[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-failure-diastolic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-failure-diastolic":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,55,83,116,139,171,193,213,261,288,313,336,358,385],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100507429","phase-2-a-randomised-controlled-trial-of-a-low-energy-diet-for-improving-functional-status-in-heart-failure-with-preserved-ejection-fraction-preserved-ejection-fraction-100507429",false,"NCT05887271","A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction","A Multi-Ethnic, Multi-centre raNdomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction (AMEND-preserved)","AMEND","Inclusion Criteria:\n\n1. Established clinical diagnosis of heart failure with preserved ejection fraction HFpEF (EF\\>45%) made by a cardiologist or a primary care physician with heart failure expertise, or a heart failure nurse\n2. Clinically stable for ≥ 3 months (no admissions to hospital)\n3. Obesity (BMI ≥30kg\u002Fm2 if white European or ≥27kg\u002Fm2 if Asian, Middle Eastern or Black ethnicity)\n4. Age ≥18\n\nExclusion Criteria:\n\n1. Inability to walk\u002Fundertake 6-minute walk test\n2. Inability to follow a low-energy MRP\n3. HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy\u002Fpericardial disease or congenital heart disease.\n4. Recovered EF (previous EF \\\u003C 40%) unless reduced EF was in context of tachycardia induced cardiomyopathy (eg AF\u002FAflutter).\n5. Known heritable, idiopathic or drug-induced pulmonary arterial hypertension\n6. Severe chronic obstructive pulmonary disease (FEV1\\\u003C 1.0L)\n7. Severe primary valvular heart disease\n8. Anaemia (Hb\\\u003C100g\u002FL)\n9. Severe renal disease (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2)\n10. Weight loss \\> 5kg in preceding 3 months.\n11. Symptomatic gallstones (including biliary colic) or cholecystitis within last 3 months\n12. Active substance abuse (drugs or alcohol)\n13. History of bariatric surgery in the last 3 years\n14. Active illness likely to cause change in weight\n15. Women who are pregnant or are considering pregnancy\n16. People currently participating in another clinical research trial that is likely to affect diet or weight change.\n17. History of a severe mental illness including an eating disorder\n\n17\\. Individuals with a diagnosis of Type 1 diabetes mellitus.","ALL","18 Years",{"count":20,"type":21},63,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Heart failure with preserved ejection fraction (HFpEF) is a common and serious complication of obesity and type 2 diabetes (T2D). HFpEF occurs when the heart muscle unable to relax efficiently to pump the blood around the body. This leads to fluid build-up, breathlessness and inability to tolerate physical exertion. People who develop HFpEF do less well because treatment options are limited. Pilot data in patients with obesity and diabetes and a small number of patients with HFpEF have shown improvements in exercise capacity and reversal of changes in the heart and blood vessels. This study will assess if this is achievable in a multi-ethnic cohort of patients with established HFpEF. A total of 63 adults will be invited and allocate by chance into two groups: 1) 12-weeks of a low calorie diet or 2) Standard care and health advice on how to lose weight followed by the option to have the low calorie diet after 12-weeks. The study will determine if weight loss over 12 weeks can improve heart function, symptoms and ability to exercise. Additionally, participants' views on changing their diet and how this has impacted their symptoms will be sought during the study in an optional interview. This will help guide treatments planning in the future to get maximum benefits, and to individualize support to patients from different cultural backgrounds.",[28,29,30,31,32],"Heart Failure With Preserved Ejection Fraction","Heart Failure, Diastolic","Diabetes Mellitus, Type 2","Diabetes Mellitus Type 2 in Obese","Obesity Adult Onset",[34,35,36,37,38,39,40,41],"Heart failure with preserved ejection fraction","Diastolic heart failure","Type 2 diabetes mellitus","Obesity","Meal replacement plan","Cardiac magnetic resonance imaging","Exercise intolerance","Diabetes remission","RECRUITING","2026-06-22",{"date":45,"type":46},"2026-06-25","ACTUAL",{"date":48,"type":46},"2023-12-05",{"date":50,"type":21},"2026-06-30",{"name":52,"class":53},"University of Leicester","OTHER",3,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100635042","phase-1-a-study-of-ly3971297-in-participants-with-heart-failure-100635042","NCT07547540","A Study of LY3971297 in Participants With Heart Failure","A Phase 1, Single-Blinded, Single-Ascending Dose Study to Evaluate the Safety and Tolerability of a Single Dose of LY3971297 in Participants With HFpEF and Participants With HFrEF","Inclusion Criteria:\n\n* Are diagnosed with chronic heart failure with New York Heart Association Class II-III (Heart Failure) HF symptomatology at screening and on guideline-directed HF therapy for at least 6 months prior to screening.\n* Have not changed optimal guideline-directed HF therapy, either medication or medication dose, in the last 4 weeks prior to screening and during screening period, and do not plan to change HF therapy for the next 90 days.\n* Must be on a stable dose of vasodilator therapy for at least 4 weeks prior to screening, with no dose adjustments planned during the study.\n* Have an estimated glomerular filtration rate of greater than or equal to (≥) 30 milliliter per minute per 1.73 square meters (mL\u002FMinute\u002F1.73m²) at screening.\n* Are between 30 days and within 12 months from recent heart failure hospitalization to screening.\n* Have systolic blood pressure (SBP) greater than (\\>) 110 millimeters of mercury (mmHg) at screening and at enrollment.\n* Have a body mass index within the range of 18.5 to 40 kilograms per square meter (kg\u002Fm²) (inclusive).\n* Are individuals assigned male or female at birth, who are not of childbearing potential.\n* Have venous access sufficient to allow blood sampling.\n* Applicable to heart failure with preserved ejection fraction (HFpEF) participants only\n\n  * Have left ventricular ejection fraction (LVEF) \\>45 percent (%).\n  * Left atrial volume index \\>34 milliliters per square meter (mL\u002Fm²) in participants in sinus rhythm, or \\>40 mL\u002Fm² in participants with atrial fibrillation (AF).\n  * N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\>300 picograms per milliliter (pg\u002FmL) for participants without AF or \\>850 pg\u002FmL for participants with AF.\n  * Have a documented history of signs, symptoms, or both, consistent with HFpEF.\n* Applicable to heart failure with reduced ejection fraction (HFrEF) participants only:\n\n  * Have LVEF \\\u003C40% .\n  * NT-proBNP \\>600 pg\u002FmL for participants without AF or \\>900 pg\u002FmL for participants with AF.\n  * Have a documented history of signs, symptoms, or both, consistent with HFrEF.\n\nExclusion Criteria:\n\n* Have known allergies to related compounds of LY3971297 or any components of the formulation, or a history of significant atopy.\n* Had a myocardial infarction, unstable angina pectoris, coronary artery bypass graft surgery, revascularization or other major cardiovascular surgery, stroke, or transient ischemic attack in the last 90 days prior to screening.\n* Have New York Heart Association (NYHA) Class 4, acute decompensated HF (exacerbation of HF) requiring IV diuretics, IV inotropes, or IV vasodilators, within 30 days prior to screening, and\u002For during screening period until randomization.\n* Have SBP ≥180 mmHg at screening.\n* Have symptomatic hypotension.\n* Have resting heart rate \\>90 beats per minute (bpm) at screening.\n* Have known cardiac amyloidosis, infiltrative myocardial diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic cardiomyopathy, pericardial constriction, or complex congenital heart disease.\n* Have any history of moderate-to-severe stenosis of the mitral and\u002For aortic valve or severe mitral and\u002For aortic regurgitation.\n* Have any history of moderate-to-severe tricuspid or pulmonic valve stenosis or severe tricuspid or pulmonic regurgitation.\n* Have a history of syncope that, in the opinion of the investigator, may affect the participant's safety.\n* Bioprosthetic valve replacement within 12 months prior to screening or any history of mechanical valve replacement, or planned valve replacement or repair during the study period.\n* Have any history of greater than moderate pulmonary hypertension.\n* Have a pacemaker or implantable cardioverter-defibrillator placement within 90 days prior to screening.\n* Have severe chronic obstructive pulmonary disease (COPD).\n* Have clinically significant or uncontrolled cardiac arrhythmia.\n* Have a significant history of, or presence of, hepatic disease, including any abnormal liver function tests.\n* Have, within 3 years prior to screening, a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (Exceptions: basal or squamous cell skin cancer).\n* For US sites: have donated blood of more than 500 mL within the previous 90 days of screening or intend to donate blood during the course of the study.\n* For Japan sites: have donated any blood within the last 4 weeks, any apheresis (blood components) within the last 2 weeks, at least 400 mL of blood within the last 16 weeks for female participants or 12 weeks for male participants, or at least 800 mL of blood for female participants or 1200 mL of blood for male participants within 12 months.\n* Other sites: Participants who have recently donated blood or blood components, or who intend to donate during the course of the study.\n* Have not been on a stable dose of medications for at least 4 weeks prior to screening, or have planned dose adjustments during the study.\n* Participants must abstain from taking new prescription or nonprescription drugs.\n* Have concurrent use or intend to use phosphodiesterase 5 inhibitor or soluble guanylyl cyclase activators.\n* Have any history of intolerance to vasodilator medications that, in the opinion of the investigator, would put them at risk of not tolerating study drug.\n* Have BP and\u002For pulse rate constituting a risk when taking the Investigational Medicinal Product (IMP).\n* Are diagnosed with orthostatic hypotension.\n* Show evidence of an acute infection with fever or infectious disease at screening.\n* Applicable to HFrEF participants only\n\n  * Have been listed for cardiac transplantation and\u002For anticipated or implanted ventricular assist device.\n  * Have received cardiac resynchronization therapy for less than 6 months.","65 Years",{"count":64,"type":21},90,[66],"PHASE1","The main purpose of this study is to assess how well LY3971297 is tolerated and what side effects may occur in participants with heart failure with preserved ejection fraction (HFpEF) and participants with heart failure with reduced ejection fraction (HFrEF). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 2 months and will include 1 inpatient visit lasting approximately 4 days and 5 outpatient visits.",[69,29,70],"Heart Failure","Heart Failure, Systolic","NOT_YET_RECRUITING","2026-06-15",{"date":74,"type":46},"2026-06-16",{"date":76,"type":21},"2026-07",{"date":78,"type":21},"2027-11",{"name":80,"class":81},"Eli Lilly and Company","INDUSTRY",10,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":96,"conditions":97,"keywords":103,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100491282","diuretics-alone-vs-aortix-endovascular-device-for-acute-heart-failure-100491282","NCT05677100","Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure","DRAIN-HF: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure","DRAIN-HF","Inclusion Criteria (Randomized Study):\n\n* Currently admitted to the hospital with a primary diagnosis of decompensated heart failure, irrespective of ejection fraction (EF);\n* Patients should be on maximally tolerated diuretic therapy and not diuresing sufficiently before being enrolled in DRAIN-HF. After being up-titrated on diuretics, patients should be followed for at least 24 hours on the higher of: i) furosemide 80 mg IV bid or equivalent or ii) IV furosemide or equivalent IV loop diuretic at a dose 2.5 x total daily home dose of furosemide equivalents in 2 divided doses, as tolerated, patient must have: Urine Output \\\u003C1,500mL in a 12-hour period OR a Net Fluid Loss ≤375mL in a 12-hour period.\n* Persistent signs and\u002For symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \\>12 cm water or ascites after treatment with IV diuretics per inclusion criterion 2.;\n* Age \\>21 years and able to provide written informed consent;\n* Negative pregnancy test if patient is of child-bearing potential.\n\nExclusion Criteria (Randomized Study):\n\n* Treatment with high dose IV inotropes within the last 48 hours prior to enrollment. High dose is defined as \\>5 µg\u002Fkg\u002Fmin dopamine OR \\>5 µg\u002Fkg\u002Fmin dobutamine OR \\>0.375 µg\u002Fkg\u002Fmin milrinone;\n* Active and ongoing hypotension with a systolic blood pressure \\\u003C90 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \\\u003C60 mmHg lasting more than 30 minutes at enrollment;\n* Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours prior to enrollment;\n* An estimated PASP of \\>80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure;\n* Acute kidney failure defined as an increase in serum creatinine to ≥4.0mg\u002FdL (≥353.6 µmol\u002FL) at enrollment;\n* Evidence of contrast induced nephropathy, nephritis or nephrotic syndrome;\n* Prior kidney transplant, single kidney, partial nephrectomy OR use of dialysis, continuous renal replacement therapy (CRRT) or ultrafiltration in the last 90 days prior to enrollment;\n* Confirmed decompensated cirrhosis (defined as Child Pugh class B or C) or concern for shock liver (AST \\> 1000U\u002FL or total Bilirubin \\> 5.0mg\u002Fdl) at enrollment;\n* Presence of an active, uncontrolled infection that would preclude safe placement or removal of the device;\n* Prior heart transplant or likely heart transplantation before the 30- day follow-up visit;\n* Current or previous support with a durable LVAD at any time or planned LVAD insertion before the 30-day follow-up visit;\n* Use of an intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g. Impella or TandemHeart) within the last 30 days;\n* Confirmed diagnosis of AL amyloidosis;\n* Acute myocardial infarction Type 1 within 30 days of enrollment, or planned coronary revascularization in the next 30 days;\n* Stroke within 30 days of enrollment;\n* Severe Bleeding Risk (any of the following):\n\n  1. Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 7 days,\n  2. GI bleeding within 6 months requiring hospitalization and\u002For transfusion,\n  3. Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding,\n  4. Procedure with arterial ilio-femoral access \\> 6 FR within 30 days,\n  5. Platelet count \\\u003C75,000 cells\u002Fmm3,\n  6. Uncorrectable bleeding diathesis or coagulopathy (e.g. INR ≥2 not due to anticoagulation therapy) or hypercoaguable state including HIT;\n  7. Inability to tolerate anticoagulation therapy for up to 7 days.\n* Contraindicated Anatomy :\n\n  1. Descending aortic anatomy that would prevent safe placement of the device \\[\\\u003C18 mm or \\>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\\],\n  2. Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath,\n  3. Femoral artery depth inconsistent with use of closure device,\n  4. Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g. aneurysm with thrombus, marked tortuosity, significant narrowing or inadequate size of the abdominal aorta, iliac or femoral arteries, or severe calcification),\n  5. Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury,\n  6. Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction\u002Fremoval of the Aortix pump as demonstrated by imaging.\n* Known hypersensitivity or contraindication to study or procedure medications (e.g. anticoagulation therapy) or device materials (e.g. history of severe reaction to nickel or nitinol);\n* Participation in any other clinical investigation that is likely to confound study results or affect the study;\n* Poor health such that the patient is unable to undergo the Aortix device placement\u002Fretrieval and\u002For unlikely to be able to survive to the 30-day visit;\n* Unable or unwilling to undergo screening (imaging, PA Catheter placement), device implant and retrieval procedures or return for 30-day visit.\n\nInclusion Criteria (Advanced Heart Failure Registry):\n\n* Currently admitted to the hospital with a primary diagnosis of decompensated HF, irrespective of ejection fraction (EF).\n* Patient has already been evaluated and indicated to receive an LVAD or heart transplant and will receive the LVAD or be listed for heart transplantation in the next 30 days if their congestion status and renal function improves.\n* Patient must have been treated with ≥ 80 mg IV furosemide bid or equivalent and have evidence of increasing diuretic dosing requirements over the past 12 months, as tolerated.\n* Must have evidence of refractoriness to medical management as documented by persistent signs and\u002For symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \\>12 cm water, or ascites after treatment with IV diuretics for a minimum of 24 hours.\n* Serum creatinine ≥ 2.0 mg\u002FdL AND eGFR ≤ 45 ml\u002Fmin\u002F1.73m2 at time of enrollment\n* Age ≥ 21 years and able to provide written informed consent.\n* Negative pregnancy test if patient is of childbearing potential.\n\nExclusion Criteria (Advanced Heart Failure Registry):\n\n* Treatment with high dose IV inotropes within 48 hours prior to enrollment. High dose is defined as any one of the following: \\>5 µg\u002Fkg\u002Fmin dopamine OR \\>5 µg\u002Fkg\u002Fmin dobutamine OR \\>0.375 µg\u002Fkg\u002Fmin milrinone.\n* Active and ongoing hypotension with a systolic blood pressure \\\u003C80 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \\\u003C55 mmHg lasting more than 30 minutes at enrollment.\n* Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours prior to enrollment.\n* An estimated PASP of \\>80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure.\n* Acute kidney failure defined as an increase in serum creatinine to ≥ 4.0mg\u002FdL at enrollment.\n* Evidence of contrast-induced nephropathy, nephritis, or nephrotic syndrome.\n* Prior kidney transplant, single kidney, partial nephrectomy OR use of dialysis, continuous renal replacement therapy (CRRT), or ultrafiltration in the last 90 days prior to enrollment.\n* Confirmed decompensated cirrhosis (defined as Child Pugh class B or C) or concern for shock liver (AST \\> 1000U\u002FL or total Bilirubin \\> 5.0mg\u002Fdl) at enrollment.\n* Presence of an active, uncontrolled infection that would preclude safe placement or removal of the device.\n* Current or previous support with a durable LVAD.\n* INTERMACS Profile 1 at enrollment.\n* Currently on mechanical ventilatory support.\n* Use of an intra-aortic balloon pump (IABP) within the last 14 days or use of an extracorporeal membrane oxygenation (ECMO) or percutaneous ventricular assist device (e.g., Impella or TandemHeart) within the last 30 days.\n* Confirmed diagnosis of AL amyloidosis.\n* Acute myocardial infarction Type 1 within 30 days of enrollment or planned coronary revascularization in the next 30 days.\n* Stroke within 30 days of enrollment.\n* Severe Bleeding Risk (any of the following):\n\n  * Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 7 days.\n  * GI bleeding within 6 months requiring hospitalization and\u002For transfusion.\n  * Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding.\n  * Procedure with arterial ilio-femoral access \\> 6 Fr within 30 days.\n  * Platelet count \\\u003C75,000 cells\u002Fmm3 .\n  * Uncorrectable bleeding diathesis or coagulopathy (e.g., INR≥ 2 not due to anticoagulation therapy) or hypercoagulable state including HIT.\n  * Inability to tolerate anticoagulation therapy for up to 7 days.\n* Contraindicated Anatomy :\n\n  * Descending aortic anatomy that would prevent safe placement of the device \\[\\\u003C18 mm or \\>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\\].\n  * Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21 Fr (outer diameter) introducer sheath.\n  * Femoral artery depth inconsistent with use of closure device.\n  * Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g., aneurysm with thrombus; marked tortuosity; significant narrowing or inadequate size of the abdominal aorta, iliac, or femoral arteries; or severe calcification).\n  * Known connective tissue disorder (e.g., Marfan Syndrome) or other aortopathy at risk of vascular injury.\n  * Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction\u002Fremoval of the Aortix pump as demonstrated by imaging.\n* Known hypersensitivity or contraindication to study or procedure medications (e.g., anticoagulation therapy) or device materials (e.g., history of severe reaction to nickel or nitinol).\n* Participation in any other clinical investigation that is likely to confound study results or affect the study.\n* Poor health such that the patient is unable to undergo the Aortix device placement\u002Fretrieval and\u002For unlikely to be able to survive to the 30-day visit.\n* Unable or unwilling to undergo screening, device implant and retrieval procedures, or return for 30-day visit.","21 Years",{"count":93,"type":21},320,[95],"NA","Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy.\n\nEligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management.",[69,98,99,100,70,29,101,102],"Cardiorenal Syndrome","Cardio-Renal Syndrome","ADHF","Heart Failure; With Decompensation","Heart Failure, Congestive",[104,105],"mechanical circulatory support","percutaneous","2026-06-05",{"date":108,"type":46},"2026-06-09",{"date":110,"type":46},"2023-08-23",{"date":112,"type":21},"2027-08",{"name":114,"class":81},"Procyrion",48,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":4},"100635588","phase-4-incretin-therapies-in-obesity-related-hfpef-100635588","NCT07554638","Incretin Therapies in Obesity-related HFpEF","Identifying Therapeutic Mechanisms for Incretin-Based Treatment in Obesity-Related Heart Failure With Preserved Ejection Fraction (HFpEF)","Inclusion Criteria:\n\n* Diagnosis of heart failure (HF) per the ACC\u002FAHA guidelines with NYHA class II-III symptoms\n* Left ventricular ejection fraction \\>= 45% within 6 months of recruitment\n* At least one of the following: elevated N-terminal pro- B-type natriuretic peptide (NT-proBNP) \\>=200 pg\u002Fml (\\>=600 pg\u002Fml with concurrent atrial fibrillation), evidence of structural heart disease (left atrial (LA) enlargement with LA volume index \\>29 mL\u002Fm2 or LA diameter \\>=40 mm in males\u002F\\>38= mm in females), elevated filling pressures (resting wedge \\>15 mmHg or exercise wedge \\>25 mmHg, lateral E\u002Fe' ratio \\>12 or septal E\u002Fe' \\> 15)\n* Body mass index (BMI) \\>30 kg\u002Fm2\n* Stable doses of HF medications within 4 weeks of screening with optimal volume control in the opinion of the investigator.\n\nExclusion Criteria:\n\n* Acute decompensated HF within 4 weeks of screening\n* Major cardiovascular event within 90 days of screening (myocardial infarction, stroke)\n* Alternate cause of HFpEF such as cardiac amyloidosis, infiltrative cardiomyopathy, hypertrophic cardiomyopathy, severe valvular disease\n* Estimated glomerular fibrilation rate (EGFR) \\\u003C15 ml\u002Fmin\u002F1.73m2 or dialysis dependence\n* Poorly controlled diabetes (A1c \\> 9.5%) OR any type 1 diabetes mellitis\n* History of acute or chronic pancreatitis\n* Personal or family history of multiple endocrine neoplasia (MEN) or medullary thyroid cancer\n* Clinically significant gastric emptying abnormality\n* Medical comorbidities that limit survival\n* Inability to comply with the study protocol\n* Pregnancy","40 Years",{"count":125,"type":21},50,[127],"PHASE4","The central hypothesis to be tested is that patients with obesity and heart failure with preserved ejection fraction (HFpEF) prescribed tirzepatide will demonstrate reductions in measured plasma volume. In conjunction with state-of-the-art body composition analysis and measures of adipokines, this will establish an important mechanism of clinical benefit and inform disease pathophysiology. To accomplish this, this study will perform a 15-month prospective cohort study in 50 patients with obesity and HFpEF who clinically qualify for treatment with tirzepatide. The investigators will serially measure plasma volume and body composition with quantitative magnetic resonance to determine changes over time with tirzepatide treatment.",[29,28,37],"2026-04-28",{"date":132,"type":46},"2026-05-04",{"date":134,"type":21},"2026-06",{"date":136,"type":21},"2030-04",{"name":138,"class":53},"Columbia University",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":170},"100625958","data-driven-phenotyping-in-heart-failure-with-preserved-ejection-fraction-100625958","NCT07429396","Data-Driven Phenotyping in Heart Failure With Preserved Ejection Fraction","Inclusion Criteria\n\n1. Retropective observational phase (Phase I):\n\n   * Age ≥18 years;\n   * Established diagnosis of heart failure with preserved ejection fraction (LVEF ≥50%);\n   * Patients receiving care (outpatient or inpatient) at the Local Health Unit of the Leiria Region (ULS RL) since September 2018.\n2. Cross-sectional observational phase (Phase II - CPET):\n\n   * Age ≥18 years;\n   * Established diagnosis of HFpEF;\n   * Selection as a volunteer representative of phenotypes identified in the retrospective clustering analysis;\n   * Provision of written informed consent prior to any study-specific procedures.\n\nExclusion Criteria:\n\n1. Retropective observational phase (Phase I):\n\n   * Incomplete or inadequate medical records preventing full data extraction.\n2. Cross-sectional observational phase (Phase II - CPET):\n\n   * Medical contraindication or physical inability to perform cardiopulmonary exercise testing (CPET);\n   * Inability to provide informed consent.",{"count":146,"type":21},200,"OBSERVATIONAL","The goal of this observational study is to learn how people with Heart Failure with Preserved Ejection Fraction (HFpEF) can be grouped into different \"phenotypes\" based on their clinical information. The researchers want to understand whether these groups have different health profiles and different responses during a cardiopulmonary exercise test (CPET).\n\nThe main questions this study aims to answer are:\n\n* Can clinical data be used to identify meaningful HFpEF phenotypes?\n* Do these phenotypes match well-known HFpEF scores, such as the H2FPEF and Heart Failure Association Pre-test Assessment, Echocardiography and Natriuretic Peptide (HFA-PEFF) scores?\n* Do people in different phenotypes show different results on a CPET?\n\nParticipants will:\n\n* Have their past clinical records reviewed if they were diagnosed with HFpEF at the Local Health Unit of the Leiria Region (ULS RL);\n* A smaller group will attend one visit to complete a CPET, which measures how the heart, lungs and muscles respond during exercise.\n\nThis study includes adults aged 18 years or older who have HFpEF. The study does not involve any new treatments or experimental drugs.",[69,29,150],"Heart Failure With Preserved Ejection Fraction (HFPEF)",[69,152,153,154,155,156,157,158,159,160],"HFpEF","Preserved Ejection Fraction","Phenotyping","Machine Learning","Data-driven clustering","Cardiopulmonary Exercise Testing","H2FPEF score","HFA-PEFF score","Exercise tolerance","2026-02-20",{"date":163,"type":46},"2026-02-24",{"date":165,"type":21},"2026-12-01",{"date":167,"type":21},"2028-05-31",{"name":169,"class":53},"Instituto Politécnico de Leiria",2,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100516803","associations-between-the-microbiome-skeletal-muscle-perfusion-and-fitness-status-100516803","NCT06009276","Associations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status","Inclusion Criteria:\n\n* Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.\n* Subjects may be of either sex with age 18 years.\n\nExclusion Criteria:\n\n* Oral antibiotic use within previous four weeks\n* Oral disease or poor oral health as determined by the Oral Health Questionnaire\n* Using an antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use\n* Tobacco smokers\n* Pregnant or lactating females\n* Hypersensitivity to any ultrasound contrast agent\n* Inability to perform exercise\n* Unable to communicate effectively in English to the study team.\n* Diagnosis of chronic renal failure (GFR \\\u003C 60 ml\u002Fmin\u002F1.73m)\n* Subjects taking nitroglycerine (or inorganic nitrates), PDE-5 inhibitors (ex: Cialis, Viagra), and xanthine oxidase inhibitors (ex: Allopurinol).",{"count":178,"type":21},70,"The purpose of the study is to determine associations between fitness status, bacteria in the mouth, and the blood flow to muscle. This study is trying to find out if fitness status impacts the bacteria that are present in the oral microbiome (environment in the mouth) or the ability of the body to send blood to the skeletal muscle.\n\nParticipants will complete all or some of the following:\n\n* A mouth swab to assess the bacteria in their mouths.\n* Produce a saliva sample into a tube.\n* Cycle on a bike until you reach maximum effort.\n* Undergo blood draws\n* Wear a 24-hour non-invasive device that monitors blood pressure.\n* Drink 70mL (1\u002F3 of a cup) of concentrated beetroot juice once",[70,29,181,182],"Peripheral Arterial Disease","Overweight and Obesity","2025-12-17",{"date":185,"type":46},"2025-12-24",{"date":187,"type":46},"2023-08-30",{"date":189,"type":21},"2026-12",{"name":191,"class":53},"University of Virginia",1,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":192},"100608248","comparative-efficacy-and-safety-of-acetazolamide-versus-metolazone-as-an-adjunct-to-standard-therapy-in-patients-with-acute-decompensated-heart-failure-100608248","NCT07199088","Comparative Efficacy and Safety of Acetazolamide Versus Metolazone as an Adjunct to Standard Therapy in Patients With Acute Decompensated Heart Failure","Inclusion Criteria:\n\n* Aged 18 years or older.\n* Diagnosed with Acute Decompensated Heart Failure (ADHF), with either preserved or reduced ejection fraction (EF).\n* At least one clinical sign of volume overload, such as:\n* Pleural effusion (confirmed by chest X-ray or ultrasound).\n* Oedema or ascites (verified by abdominal ultrasonography).\n* Plasma NT-proBNP level \\> 1000 pg\u002FmL or BNP level \\> 250 ng\u002FmL at screening.\n* Receiving at least 40 mg of furosemide as oral maintenance therapy for at least one month prior to the study initiation.\n\nExclusion Criteria:\n\n* Previous use of acetazolamide or metolazone prior to the study period.\n* Known hypersensitivity or allergies to the study drugs (acetazolamide or metolazone) or their components.\n* Patients with electrolyte disturbances, especially hypokalemia.\n* End-stage renal disease requiring dialysis or GFR \\\u003C 20 mL\u002Fmin\u002F1.73 m².\n* Pregnant or breastfeeding women.\n* Severe hypotension (systolic blood pressure \\\u003C 90 mmHg) or other significant comorbidities like congenital cardiac illness requiring surgery.\n* Patients requiring renal replacement therapy during the hospitalization.\n* History of significant electrolyte imbalances or acid-base disturbances.",{"count":93,"type":21},[95],"This clinical trial aims to compare the efficacy and safety of acetazolamide versus metolazone as adjunctive treatments to standard therapy in patients with acute decompensated heart failure (ADHF). ADHF is a life-threatening condition, and current treatments often involve loop diuretics to alleviate volume overload. This study will assess the added benefit of acetazolamide and metolazone in improving decongestion, reducing hospital stays, and preventing complications such as renal dysfunction or electrolyte imbalances. Participants will be randomized to receive either acetazolamide or metolazone in addition to standard diuretic therapy. The trial will evaluate primary outcomes including successful decongestion, in-hospital mortality, and length of hospital stay, with secondary outcomes focusing on renal function, electrolyte disturbances, and overall safety. The study is conducted at Bahawal Victoria Hospital, Bahawalpur, and aims to provide valuable insights into the management of ADHF, especially in the Pakistani population.",[203,29,70],"Acute Decompensated Heart Failure","2025-09-29",{"date":206,"type":46},"2025-10-03",{"date":208,"type":21},"2025-10-11",{"date":210,"type":21},"2026-10-30",{"name":212,"class":53},"University of Health Sciences Lahore",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":223,"conditions":224,"keywords":246,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":192},"100435439","prevalence-and-risk-factors-associated-with-cardiac-comorbidity-in-psoriasis-100435439","NCT04950218","Prevalence and Risk Factors asSOciated With CArdiac comorbiDIty in psoriAsis","PSOCADIA: Prevalence and Risk Factors asSOciated With CArdiac comorbiDIty in psoriAsis","PSOCADIA","Inclusion Criteria:\n\n* Patients 18 years or older with a diagnosis of psoriasis will be invited to participate\n\nExclusion Criteria:\n\n* Patients not able to cooperate to the study\n* Patients unable understand and sign informed consent",{"count":222,"type":21},1000,"In a prospective cohort study (n = 1.000), the investigators aim to investigate the correlation between cardiac biomarkers and advanced echocardiography and determine whether these are prognostic markers of heart disease in patients suffering from psoriasis.",[225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,69,244,245,70,29],"Psoriasis","Cardiovascular Diseases","Cardiovascular Risk Factor","Cardiovascular Pathology","Psoriasis Vulgaris","Psoriatic Nail","Psoriasis Face","Psoriasis Guttate","Psoriasis Gyrata","Psoriasis Diffusa","Psoriasis Palmaris","Psoriasis Annularis","Psoriasis Circinata","Psoriasis Plantaris","Psoriasis Universalis","Psoriasis Geographica","Left Ventricular Dysfunction","Myocardial Infarction","Myocardial Ischemia","Stroke","Heart Diseases",[225,247,248,249,250,251],"Echocardiography","Advanced echocardiography","Biomarkers","Mortality","Cardiovascular mortality","2025-09-09",{"date":254,"type":46},"2025-09-15",{"date":256,"type":46},"2021-09-01",{"date":258,"type":21},"2034-10-01",{"name":260,"class":53},"Herlev and Gentofte Hospital",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":270,"conditions":271,"keywords":274,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":287},"100576454","multiple-biomarker-approach-for-individualized-treatment-of-heart-failure-with-preserved-ejection-fraction-100576454","NCT06785506","Multiple-biomarker Approach for Individualized Treatment of Heart Failure with Preserved Ejection Fraction","A Dynamic, Multiple-biomarker Approach Aiming for Individualized Treatment of Heart Failure with Preserved Ejection Fraction (ADAPT-HFpEF)","ADAPT-HFpEF","Inclusion Criteria:\n\n* Age of 18 years or older\n* Capable of understanding and signing informed consent\n* A diagnosis of HFpEF according to the HFA-PEFF diagnostic algorithm of the ESC or\u002Fand a high (90%) probability of HFpEF according to the H2FPEF score, i.e. a score of 6 or higher.\n\nExclusion Criteria:\n\n* History of LVEF ≤40%\n* Scheduled for surgery or intervention for both coronary and non-coronary indication within 6 months of inclusion\n* Impaired renal function, defined as eGFR \\\u003C 20 mL\u002Fmin\u002F1.73 m2 (CKD-EPI) or requiring dialysis at the time of screening\n* Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening\n* COPD Gold stage IV\n* Congenital heart disease\n* Pregnancy\n* Coexistent condition with life expectancy of \\\u003C1 year\n* Unlikely to appear at all scheduled follow-up visits\n* Linguistic barrier",{"count":146,"type":21},"The primary objective is to investigate the association between temporal evolutions of blood biomarkers and clinical adverse events, in order to produce a dynamic, individual, and accurate prediction model for patients with HFpEF.\n\nMoreover several secondary objectives will be investigated.",[272,29,273],"Heart Failure with Preserved Ejection Fraction","Chronic Heart Failure",[152,275,276,277],"Heart failure","preserved ejection fraction","biomarkers","2025-01-20",{"date":280,"type":46},"2025-01-21",{"date":282,"type":46},"2022-11-25",{"date":284,"type":21},"2026-09-01",{"name":286,"class":53},"Erasmus Medical Center",6,{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":298,"briefSummary":299,"conditions":300,"keywords":303,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":192},"100483652","prevalence-and-prediction-of-attr-in-ambulatory-patients-with-hfpef-100483652","NCT05577819","Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF","Prevalence and Prediction of Transthyretin Amyloidosis in Ambulatory Patients With Heart Failure With Preserved Ejection Fraction","TTRinHFpEF","Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of HFpEF.\n* Age ≥65 years old\n\nExclusion Criteria:\n\n* End stage chronic kidney disease on dialysis (CKD stage 5 as defined as eGFR \\\u003C15mL\u002Fmin)\n* no history of HFrEF (LVEF\\\u003C40%) with the exception of low LVEF in the setting of acute decompensation, AF RVR, ACS\u002FMI, etc\n* Negative 99mTc-pyrophosphate scan within a year\n* Unable to lie down for 15 minutes for the 99mTc-pyrophosphate scan\n* Known diagnosis of amyloidosis\n* Severe valvular heart disease that is uncorrected (moderate to severe is considered exclusionary)",{"count":297,"type":21},515,[95],"Recent studies have shown that transthyretin amyloidosis (ATTR) can sometimes cause a type of heart failure where the pumping function of the heart is normal, also known as Heart Failure with Preserved Ejection Fraction (HFpEF) or diastolic heart failure. In this single center diagnostic study, we will evaluate for ATTR in patients with HFpEF in order to to determine how frequently this occurs and how we can predict which heart failure patients may have TTR amyloidosis. Our goal is to identify amyloidosis in heart failure patients earlier so that they can start treatment.",[301,69,29,302],"Transthyretin Amyloidosis","Amyloidosis",[301,69,29,302],"2024-12-06",{"date":306,"type":46},"2024-12-09",{"date":308,"type":46},"2020-10-02",{"date":310,"type":21},"2026-12-31",{"name":312,"class":53},"Massachusetts General Hospital",{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":321,"conditions":322,"keywords":323,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":192},"100476110","value-of-intense-phenotyping-in-heart-failure-with-preserved-ejection-fraction-100476110","NCT05479669","Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction","VIP-HF2","Inclusion Criteria:\n\nClinical criteria:\n\n1. Age \\>18 years\n2. Written informed consent\n3. HF with moderate to severe symptoms NYHA II or III\n4. Hospitalization or emergency room visit for HF or symptom relief with diuretics\n5. Sinus rhythm or AF\n\nEchocardiographic criteria:\n\n1. LVEF \\>0.40\n2. Left atrial size (volume ≥29 mL\u002Fm2 or LA parasternal diameter ≥45), or left ventricular hypertrophy (septal thickness or posterior wall thickness ≥11 mm) or LV diastolic dysfunction (E\u002Fe' ≥13 or mean e' septal and lateral wall \\\u003C9 cm\u002Fs).\n\nBiomarker criteria:\n\n1. BNP \\>31ng\u002FL or NT-pro-BNP\\>125ng\u002FL if sinus rhythm\n2. BNP \\>75ng\u002FL or NT-pro-BNP\\>300ng\u002FL if atrial fibrillation\n\nExclusion Criteria:\n\n1. Patients unwilling or unable to sign informed consent\n2. Patients with a pacemaker or ICD\n3. Indication for ICD therapy according to the ESC guidelines\n4. Life expectancy of less than one year\n5. Significant coronary artery disease or myocardial infarction \\\u003C 3 months\n6. Complex congenital heart disease\n7. Pregnancy",{"count":146,"type":21},"Heart failure (HF) with a left ventricular ejection fraction (LVEF) \\>0.40 is a large medical problem, for which no drug or device has a recommendation in current HF guidelines. The prevalence of mortality and HF hospitalizations in HF with LVEF \\>0.40 is high, but the identification of predictors for increased risk of mortality and HF hospitalizations in this patient category remains difficult. The hypothesis of this study is that the risk of all-cause mortality and HF hospitalizations can be measured by clinical factors, imaging parameters and circulating biomarkers, and that these factors can be used in a risk profile",[29],[324,152,325,326],"heart failure with preserved ejection fraction","cardiac MRI","99mTc-HDP scan","2024-05-15",{"date":329,"type":46},"2024-05-16",{"date":331,"type":46},"2022-03-29",{"date":333,"type":21},"2031-01-01",{"name":335,"class":53},"University Medical Center Groningen",{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":17,"minAge":344,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":346,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":170},"100520821","phase-1-modulation-of-serca2a-of-intra-myocytic-calcium-trafficking-in-heart-failure-with-preserved-ejection-fraction-100520821","NCT06061549","Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction","A Phase 1b, Pilot Trial Evaluating the Safety and Pharmacodynamic Effects of SRD-001 (AAV1-SERCA2a) in Subjects With Heart Failure With Preserved Ejection Fraction","MUSIC-HFpEF","Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Negative for anti-AAV1 neutralizing antibodies\n* NYHA class II or III\n* Left ventricular ejection fraction ≥ 50%\n* Evidence of resting or exercise-induced left ventricle filling pressure\n* On oral diuretic therapy\n* Adequate birth control\n\nExclusion Criteria:\n\n* NYHA class IV\n* Heart failure requiring hospitalization in the past 3 months\n* Manifested or provocable ischemic heart disease\n* Atrial fibrillation\n* History of congenital heart disease, restrictive or infiltrative cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm\n* History of amyloidosis\n* Untreated left-sided valvular disease\n* Severe COPD\n* BMI \\> 50 kg\u002Fm\\^2\n* Severe liver, kidney or hematologic dysfunction\n* Cancer within the past 5 years\n* Unstable concurrent conditions","50 Years",{"count":82,"type":21},[66],"The goal of this clinical trial is to test an experimental gene therapy in participants with heart failure with preserved ejection fraction, also known as diastolic heart failure. The main questions it aims to answer are:\n\n* safety and tolerability of the gene therapy; and\n* whether the gene therapy helps the heart ventricles relax during filling. Participants will undergo a one-time infusion of the gene therapy in the cardiac catheterization laboratory and then be followed for safety and effects on left-sided filling pressures while exercising. The first year will have multiple in-person visits followed by 4 years of biannual phone calls.",[29,28],"2023-09-23",{"date":351,"type":46},"2023-09-29",{"date":353,"type":46},"2023-08-24",{"date":355,"type":21},"2029-08",{"name":357,"class":81},"Sardocor Corp.",{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":365,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":368,"conditions":369,"keywords":370,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":192},"100408817","multimodality-imaging-in-the-screening-diagnosis-and-risk-stratifiction-of-hfpef-100408817","NCT04603404","Multimodality Imaging in the Screening, Diagnosis and Risk StratifictiON of HFpEF","Multimodality Imaging (Cardiovascular Magnetic Resonance Imaging, Echocardiography, and Nuclear Medicine Imaging) in the Screening, Diagnosis and Risk Stratification of Heart Failure With Preserved Ejection Fraction (HFpEF).","Inclusion Criteria:\n\n* left ventricular ejection fraction (LVEF)≥50%；\n* N-terminal pro-b type natriuretic peptide (NT-proBNP)\\>220pg\u002Fml or b type natriuretic peptide (BNP) \\>80 pg\u002Fml;\n* symptoms and syndromes of heart failure;\n* At least one criteria of cardiac structure (left ventricular hypertrophy, or left atrial enlargement) and function abnormalities (based on tissue doppler, color doppler).\n\nExclusion Criteria:\n\n* Special types of cardiomyopathy, including hypertrophic cardiomyopathy, restricted cardiomyopathy, etc.\n* Infarction, myocardial fibrosis caused by ischemic cardiomyopathy and acute coronary syndrome ;\n* Severe arrhythmia;\n* Severe primary cardiac valvular disease;\n* Restrictive pericardial disease;\n* Refuse to participate in the study.",true,{"count":367,"type":21},430,"The incidence of Heart failure with preserved ejection fraction (HFpEF) in Heart failure patients increases rapidly. However, the current clinical awareness is insufficient, and the cardiac structural and functional injury are not well understood. It is difficult to recognize the subclinical changes of the cardiac in the early stage with conventional imaging techniques, and it is common to ignore the existence of the clinical alterations. This study aimed to investigate the cardiac features, early diagnosis and risk factors of HFpEF patients, based on the multi-modal (Magnetic resonance imaging- nuclear medicine imaging- echocardiography) imaging, combined with large data and artificial intelligence. This study will provide deep insights into the HFpEF derived from different causes.",[29],[324,371,372,373,374,375],"cardiovascular magnetic resonance imaging","echocardiography","nuclear medicine imaging","early diagnosis","prognosis","2022-11-05",{"date":378,"type":46},"2022-11-08",{"date":380,"type":46},"2019-01-01",{"date":382,"type":21},"2030-12",{"name":384,"class":53},"Chinese Academy of Medical Sciences, Fuwai Hospital",{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":365,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":391,"targetDuration":392,"studyType":147,"phases":4,"briefSummary":393,"conditions":394,"keywords":396,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":192},"100408735","diagnosis-and-outcomes-evaluation-of-multicenter-patients-with-hfpef-using-multimodality-imaging-100408735","NCT04602338","Diagnosis and OutcoMes evaluAtIoN of Multicenter Patients With HFpEF Using Multimodality Imaging","Multimodality Imaging (Cardiovascular Magnetic Resonance Imaging, Echocardiography, and Nuclear Medicine Imaging) in the Screening, Diagnosis and Risk Stratification of Heart Failure With Preserved Ejection Fraction- a Multicenter Study.",{"count":222,"type":21},"8 Years","The incidence of Heart failure with preserved ejection fraction (HFpEF) in Heart failure patients increases rapidly. However, the current clinical awareness is insufficient, and the cardiac structural and functional injury are not well understood. It is difficult to recognize the subclinical changes of the cardiac in the early stage with conventional imaging techniques, and it is common to ignore the existence of the clinical alterations. This study aimed to investigate the cardiac features, early diagnosis and risk factors of HFpEF patients, based on the multi-modality (Magnetic resonance imaging- nuclear medicine imaging- echocardiography) imaging and multicenter study, combined with large data and artificial intelligence. This study will provide deep insights into the HFpEF in multicenter population.",[29,395],"Multicenter Study",[324,371,372,373,374,375],"2022-04-14",{"date":399,"type":46},"2022-04-18",{"date":401,"type":46},"2020-11-01",{"date":403,"type":21},"2028-06",{"name":384,"class":53}]