[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"reduced-ejection-fraction-heart-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:reduced-ejection-fraction-heart-failure":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100590291","initiation-and-titration-of-guideline-directed-medical-therapy-in-heart-failure-cardiogenic-shock-with-impella-55-for-cardiac-recovery-100590291",false,"NCT06965504","INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery","Initiation and Titration of Guideline Directed Medical Therapy in Heart Failure Cardiogenic Shock With Impella 5.5 for Cardiac Recovery: INTeGRATE","INTeGRATE","Inclusion Criteria:\n\n1. Age ≥ 18 and \\\u003C 80 years\n2. Subject has signed the Informed Consent Form. If the subject has been enrolled via an LAR, the subject must provide assent, the assent will be documented.\n3. LVEF ≤ 40%\n4. Subject is presenting with decompensated heart failure and meets at least one (1) of the following cardiogenic shock criteria:\n\n   1. Sustained episode of systolic blood pressure ≤ 90 mmHg for at least 30 minutes or need for vasoactive agents to maintain such blood pressure.\n   2. Cardiac index (CI) \\\u003C 2.2 L\u002Fmin\u002Fm2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia.\n   3. Require support with an intra-aortic balloon pump (IABP)\n   4. Serum lactate \\>2 mmol\u002FL\n5. Subject has inadequate heart failure GDMT based on the most recent outpatient prescription prior to index admission, defined as:\n\n   1. On 2 or less of the 4-Pillar HF Drug Classes (BB, MRA, SGLT2i, and RASi)\n   2. If on BB and RASi, at least one of the two medications is \\\u003C 50% of the maximal target dose.\n\nExclusion Criteria:\n\n1. Underlying unmodifiable conditions that limit initiation of GDMT prior to enrollment, including but not limited to:\n\n   1. Drug allergies or hypersensitivities\\* to HF GDMT medications, unless alternative can be identified.\n\n      \\*Drug allergy\u002Fhypersensitivity is an immune-mediated reaction to a medication. Adverse reactions must be a result of immune or inflammatory cell stimulations by the mеԁiсаtion.\n   2. Known bilateral renal artery stenosis\n   3. Type 1 diabetes\n   4. 2o or 3o AV block, unless pacemaker is in place\n   5. Angioedema, hereditary or idiopathic\n   6. Pregnancy, known or confirmed by a pregnancy test if of childbearing potential\n2. ST-segment elevation or acute coronary syndrome (ACS) prior to enrollment\n3. Septic shock, shock from non-cardiac origins, or mixed shock\n4. SCAI Stage E cardiogenic shock per study definition (Appendix C) prior to enrollment\n5. In cardiac arrest prior to enrollment\n6. Intra-aortic balloon pump (IABP) use \\>24 hours from the onset of cardiogenic shock if placed at the enrolling site or \\>48 hours if transferred on IABP prior to enrollment\n7. On mechanical circulatory support other than IABP (i.e. ECMO, Impella CP, etc) or on mechanical ventilation for non-procedural reasons prior to enrollment\n8. Revascularization or cardiac surgery within 30-days of the index hospitalization date or decision to undergo revascularization or cardiac surgery made prior to enrollment\n9. Infiltrative\u002Frestrictive cardiomyopathy (sarcoidosis and amyloidosis), hypertrophic cardiomyopathy, constrictive pericarditis, pericardiac tamponade, or fulminant myocarditis (giant cell or immune checkpoint inhibitor)\n10. Complex adult congenital heart disease\n11. Primary severe valvular disease\n12. Predominant RV dysfunction per Investigator's discretion\n13. History of heart transplant or listed for heart transplant or planned for heart transplantation prior to enrollment.\n14. Planned to be implanted with a permanent VAD within 180-days of the index hospitalization date.\n15. Continuous outpatient inotropic support prior to the index hospitalization date.\n16. Planned to pursue palliative care or hospice, or life expectancy of less than 1 year due to non-cardiac illness at the time of index hospitalization date.\n17. Currently on dialysis, or has pre-existing end-stage chronic kidney disease (stage 4 and above), or has nephropathy of hereditary, infectious, or autoimmune origin.\n18. Pre-existing liver disease including liver cirrhosis, alcoholic hepatitis, metabolic dysfunction associated steatohepatitis (MASH), or genetic liver disease.\n19. Pre-existing pulmonary disease with oxygen dependency.\n20. History of stroke or intracranial hemorrhage ≤ 90 days prior to the index hospitalization date, or a history of cerebrovascular disease with significant (\\> 80%) uncorrected carotid stenosis, or any permanent neurological deficit with modified Rankin Scale (mRS) \\>2.\n21. Any contraindication that precludes placing an Impella 5.5®, including but not limited to:\n\n    1. Aortic valve stenosis\u002Fcalcification with orifice area ≤ 0.6cm2 or aortic insufficiency of any grade greater than mild on pre-procedure echocardiography.\n    2. Presence of mechanical aortic valve or heart constrictive device\n    3. Thrombus in the left atrium or ventricle\n    4. Infection of the planned procedural access site or suspected systemic active infection.\n    5. Severe arterial disease precluding placement of Impella\n    6. Presence of Atrial or Ventricular Septal Defect\n    7. Left ventricular rupture\n    8. Cardiac tamponade\n    9. Combined cardiorespiratory failure\n22. Intolerance to anticoagulant or antiplatelet therapies, or will refuse blood transfusions.\n23. Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent (or assent if LAR) and\u002For to comply with study procedures.\n24. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device.\n25. Subject belongs to a vulnerable population, such as prisoners, pregnant women, handicapped, mentally disabled persons, or economically or educationally disadvantaged persons per 21CFR56.111(a)(3) and 111(b).","ALL","18 Years","80 Years",{"count":21,"type":22},250,"ESTIMATED","INTERVENTIONAL",[25],"NA","The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.",[28,29,30],"Heart Failure","Cardiogenic Shock","Reduced Ejection Fraction Heart Failure",[32,33,30,34,35,36,37],"Impella 5.5","Heart Failure Cardiogenic Shock","Mechanical Circulatory Support","Cardiovascular Disease","Heart Disease","Guideline Directed Medical Therapy","NOT_YET_RECRUITING","2026-04-20",{"date":41,"type":42},"2026-04-23","ACTUAL",{"date":44,"type":22},"2026-04-01",{"date":46,"type":22},"2029-06-01",{"name":48,"class":49},"Abiomed Inc.","INDUSTRY",7,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100606117","personalized-iot-based-physical-activity-monitoring-system-for-heart-failure-patients-100606117","NCT07171372","Personalized IoT-based Physical Activity Monitoring System for Heart Failure Patients","Personalized IoT-based Physical Activity Monitoring System for Heart Failure Patients (IoT-HFActive): Rationale and Methodological Protocol for a Randomized Clinical Trial","IoT-HFActive","Inclusion Criteria:\n\n* Diagnosis of HF confirmed by echocardiographic examination,\n* Heart failure characterized by reduced ejection fraction (HFrEF),\n* Individuals aged 18-75 years,\n* New York Heart Association (NYHA) functional class I, II, or III,\n* No evidence of ischemia on coronary angiography performed within the last three months,\n* No physical limitations preventing exercise,\n* Standardized Mini-Mental State Examination (MMSE) score ≥ 25,\n* Ownership of a smartphone compatible with the mobile application to be used in the study.\n\nExclusion Criteria:\n\n* Presence of an ischemic lesion requiring revascularization on coronary angiography,\n* History of major cardiac surgery within the last three months,\n* Worsening dyspnea at rest and exercise intolerance,\n* Presence of arrhythmia problems such as ventricular tachyarrhythmia or atrial fibrillation,\n* Uncontrolled diabetes (Hemoglobin A1C ≥ 7 mg\u002Fdl),\n* Presence of chronic pulmonary disease or renal insufficiency,\n* Symptomatic postural hypotension (≥20 mmHg systolic drop),\n* Score ≥ 9 on the Edmonton Frail Scale (moderate to severe frailty),\n* Morbid obesity (BMI \\> 40 kg\u002Fm²),\n* Neuropsychiatric disorders severely impairing cognitive functions such as dementia or Alzheimer's disease,\n* Unwillingness to participate in the exercise program.","75 Years",{"count":61,"type":22},82,[25],"Current literature emphasizes the importance of increasing physical activity, ensuring its continuity, and reducing sedentary behaviors in patients with heart failure (HF). Many patients are referred to exercise-based rehabilitation programs following hospital discharge or an acute cardiac event. Although the benefits of these programs on cardiovascular health have been consistently demonstrated, adherence to recommended exercise regimens remains a major challenge. Previous studies indicate that through repeated and effective national health policies, large segments of society have adopted strategies to promote physical activity. However, despite the availability of various exercise and physical activity protocols, patients with HF remain prone to sedentary behaviors due to physical limitations, psychosocial factors, and lack of motivation.\n\nHealthcare professionals play a critical role in promoting physical activity among HF patients, as encouraging participation in structured programs may improve health outcomes and reduce sedentary behaviors. Therefore, developing new and effective strategies to increase physical activity levels in this population is essential. Such strategies should focus on tailoring interventions to individual needs and health conditions, implementing long-term monitoring and support mechanisms to ensure continuity, and integrating technological innovations (e.g., smart wristbands, mobile applications) through user-friendly interfaces.\n\nThis study aims to improve physical activity levels and reduce sedentary behaviors among HF patients by designing a personalized, Internet of Things (IoT)-based physical activity monitoring system (IoT-HFActive). The central innovation of this system lies in its ability to generate personalized physical activity goals for the first time through automated mathematical algorithms that process real-time data collected from wearable devices.\n\nDuring supervised exercise sessions, heart rate measurements obtained via smart wristbands will be used to calculate individual heart rate reserves (HRR). Based on these data, personalized activity goals will be established, including target heart rate zones, exercise intensity, and weekly activity duration. Subsequently, the server system will continuously monitor participants' daily physical activity levels and, through a specifically developed mobile application, provide real-time visualization of the results on participants' smartphones.\n\nThe system is designed with multiple functional components. Beyond setting personalized, patient-centered physical activity goals, it will also monitor adherence, deliver behavioral support techniques, and adapt targets over time. Participants will receive periodic individualized feedback, rewards such as virtual badges, progress visualizations, and video-supported motivational messages to reinforce engagement. Repeated time-series measurements of physical activity will allow dynamic recalibration of goals based on participants' performance.\n\nIn addition, participants will be able to track their personal progress, receive visual and video-based feedback, and observe how their activity behavior improves over time. These features are expected to strengthen motivation and adherence to exercise programs. Throughout the study, all procedures will be designed to align with participants' abilities and will be supported by user-friendly, intuitive interfaces to ensure accessibility and usability.\n\nBy combining personalized physical activity goals, real-time monitoring, and behaviorally informed feedback strategies, this study introduces an innovative, patient-centered IoT-based approach. The IoT-HFActive system is expected to address the long-standing challenge of exercise adherence in HF patients and to provide valuable evidence for the integration of technological innovations into cardiac rehabilitation services.",[28,30],[66,67,68,69,70,71,72],"heart failure","internet of things","physical activity","rehabilitation","sedentary behavior","telemedicine","wearable electronic devices","2025-09-06",{"date":75,"type":42},"2025-09-12",{"date":77,"type":22},"2025-12-13",{"date":79,"type":22},"2027-03-13",{"name":81,"class":82},"Abant Izzet Baysal University","OTHER"]