[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-failure-with-moderately-reduced-ejection-fraction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-failure-with-moderately-reduced-ejection-fraction":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"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":25,"conditions":26,"keywords":32,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100444229","assessment-of-ccm-in-hf-with-higher-ejection-fraction-100444229",false,"NCT05064709","Assessment of CCM in HF With Higher Ejection Fraction","Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction","AIM HIGHer","Inclusion Criteria:\n\n1. Signed and dated informed consent form;\n2. Male or non-pregnant female, 18 years or older;\n3. Diagnosed with symptomatic heart failure;\n4. LVEF ≥40 and ≤70% (as assessed by site echo);\n5. A. Heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent OR B. If there is no heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent, an elevated BMI-adjusted natriuretic peptide value must be achieved (Refer to Table 1 in Section 9.2.6)\n6. Subjects must meet one of the following conditions:\n\n   * Have stable, scheduled oral loop diuretic treatment (not just PRN) for a minimum of 30 days before providing study consent unless there is a documented allergy or intolerance.\n   * Eligibility for enrollment is maintained for patients on an SGLT2 inhibitor without prescribed concurrent standing loop diuretic therapy if investigators provide instructions for a flexible PRN diuretic regimen (deemed appropriate by the clinician in response to symptoms or weight gain) Note: Stable is defined as no more than a 100% increase or 50% decrease in dose within the last 30 days. A one-time hold of diuretic dosing for 24 hours during the 30-day period is allowed and not an exclusionary event.\n\nExclusion Criteria:\n\n1. Resting ventricular rate \\\u003C50 or \\>110 bpm;\n2. Resting systolic blood pressure \\\u003C100 or ≥160 mmHg;\n3. BMI greater than 46\n4. Any severe valvular stenotic disease or any severe valvular regurgitation;\n5. Mechanical tricuspid valve;\n6. Complex congenital heart disease;\n7. Exercise tolerance limited by a condition other than heart failure that, in the opinion of the investigator, contributes significantly to the primary symptoms of shortness of breath and\u002For exercise intolerance;\n8. Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT;\n9. A KCCQ CCS score higher than 85;\n10. Hypertrophic, infiltrative\u002Frestrictive or inflammatory cardiomyopathy;\n11. Unstable angina pectoris within 30 days prior to study consent;\n12. Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting;\n13. Receiving cardiac resynchronization therapy (CRT); NOTE: Subjects with active\u002Fongoing cardiac resynchronization therapy (CRT) implanted more than one year ago are eligible for inclusion if they are currently classified as NYHA class III or higher.\n14. Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or have undergone cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;\n15. Myocardial infarction within 90 days prior to study consent;\n16. Prior heart transplant or ventricular assist device;\n17. Planning to become pregnant during the study;\n18. Dialysis (permanent) or GFR \\\u003C15 ml\u002Fmin\u002F1.73m2;\n19. Participating in another investigational drug or device study that may interfere with the interpretation of study data;\n20. Currently undergoing active chemotherapeutic and\u002For radiation treatment for cancer or has a history of chemotherapy during the 2-year period prior to study consent;\n21. Expected lifespan of less than 18 months from time of study consent;\n22. Unable to follow through study protocol for any reasons in the investigator's judgement.","ALL","18 Years",{"count":20,"type":21},1500,"ESTIMATED","INTERVENTIONAL",[24],"NA","The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.",[27,28,29,30,31],"Heart Failure","Heart Failure With Preserved Ejection Fraction","Heart Failure With Mid Range Ejection Fraction","Heart Failure With Moderately Reduced Ejection Fraction","Diastolic Heart Failure",[33,34,35,36,37,38,39,40,41,42,43],"HFpEF","Heart failure","CCM","CCM therapy","cardiac contractility modulation","symptomatic heart failure","left ventricular ejection fraction","LVEF","Optimizer","Optimizer Smart Mini","Quality of Life","RECRUITING","2026-06-24",{"date":47,"type":48},"2026-06-26","ACTUAL",{"date":50,"type":48},"2022-02-03",{"date":52,"type":21},"2029-02-01",{"name":54,"class":55},"Impulse Dynamics","INDUSTRY",105,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100478289","phase-3-the-effect-of-sacubitrilvalsartan-versus-ramipril-on-left-ventricular-function-and-remodeling-in-patients-with-ischemic-heart-failure-with-mid-range-ejection-fraction-100478289","NCT05508035","The Effect of Sacubitril\u002Fvalsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients with Ischemic Heart Failure with Mid-range Ejection Fraction","CRACOVIA-HF","Inclusion Criteria:\n\n* Written consent to participate in the study, expressed prior to any procedures related to the study.\n* Age 18 and over.\n* Symptomatic HF in NYHA class II to IV of ischemic etiology.\n* Left ventricular ejection fraction at screening visit ranged from 40-49%.\n* Elevated concentration of NT-proBNP natriuretic peptide ≥125 pg\u002Fml.\n* Features of a structural \u002F functional disease of the left ventricle.\n* Optimal pharmacotherapy with ACEI or ARB and beta-blocker, unless they are contraindicated.\n\nExclusion Criteria:\n\n* History of hypersensitivity or allergy to any of the drugs tested or drugs of similar chemical class, ACEIs, ARBs or neprilysin inhibitors.\n* Previous history of intolerance to recommended ACEI or ARB target doses.\n* Known history of angioedema.\n* Requirement of simultaneous treatment with ACEI and ARB.\n* Acute decompensated HF within 6 weeks prior to screening visit.\n* Symptomatic hypotension systolic blood pressure \\\u003C100 mmHg at screening visit.\n* Current or previous treatment with sacubitril \u002F valsartan.\n* Estimated creatinine clearance \\\u003C30 ml \u002F min \u002F 1.73 m2 at screening visit.\n* Serum potassium \\>5.2 mmol \u002F L at screening visit.\n* Acute coronary syndrome or elective revascularization within 6 weeks prior to screening.\n* Stroke, transient ischemic attack, carotid angioplasty, heart surgery, or any other major cardiovascular surgery in the 3 months prior to screening.\n* Implantation of a cardioverter defibrillator, pacemaker, or resynchronization therapy device incompatible with MRI.\n* Fixed atrial fibrillation.",{"count":65,"type":21},666,[67],"PHASE3","Heart failure with moderately reduced ejection fraction (HFmrEF) is a frequent disease associated with significant morbidity and mortality and therefore requires effective therapies that may improve clinical outcomes. The most common reason of HFmrEF is ischemic injury, usually caused by myocardial infarction, that may lead to left ventricular remodeling and systolic dysfunction, accompanied by symptoms of heart failure. Therefore, the anti-remodeling therapies may effectively improve clinical outcomes. Recently, sacubitril\u002Fvalsartan - the angiotensin receptor neprilysin inhibitor suppressing the renin-angiotensin-aldosterone system and enhancing the effect of natriuretic peptides - has been introduced in the treatment of heart failure. To date, this drug was found to be clinically beneficial in patients with heart failure with reduced ejection fraction (HFrEF), however has not been tested in the group of patients with HFmrEF.\n\nThe aim of the study is to evaluate effectiveness of sacubitril\u002Fvalsartan as compared with ramipril on left ventricular remodeling and function in patients with ischemic HFmrEF.\n\nPatients with ischemic HFmrEF, New York Heart Association class II-IV symptoms, an elevated plasma natriuretic peptide level and the left ventricular ejection fraction (LVEF) of 40-49 % will be enrolled in this prospective, multicenter, randomized, double-blind, active-controlled study. Initially, patients will enter a single-blind ramipril run-in period (titrated to 5 mg bid), followed by a sacubitril\u002Fvalsartan run-in period (100 mg titrated to 200 mg bid). A total of 666 patients tolerating both periods will be randomized 1:1 to either ramipril 10 mg bid or sacubitril\u002Fvalsartan 200 mg bid. The primary endpoint will be the change of left ventricular end-systolic volume index within 12-month of treatment as measured by magnetic resonance imaging. The main secondary endpoints include the change of left ventricular end-diastolic volume index within 12-month of treatment, the change of LVEF within 12-month of treatment, 12-month composite endpoint of cardiovascular death or heart failure requiring hospitalization, 12-month cardiovascular death, 12-month heart failure requiring hospitalization, time to death or heart failure requiring hospitalization or mortality rate within 12-month of treatment.\n\nThis study may determine the place of sacubitril\u002Fvalsartan as an alternative to ramipril in the treatment of patients with ischemic HFmrEF in order to prevent further left ventricular remodeling and to improve its systolic function.",[70],"Heart Failure with Moderately Reduced Ejection Fraction",[72,73],"chronic heart failure","congestive heart failure","2024-10-29",{"date":76,"type":48},"2024-10-31",{"date":78,"type":48},"2023-07-13",{"date":80,"type":21},"2027-06",{"name":82,"class":83},"John Paul II Hospital, Krakow","OTHER",1]