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Heart Failure clinical trials

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NCT ID: NCT06154044 Recruiting - Heart Failure Clinical Trials

Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support

Start date: May 1, 2022
Phase: Phase 2
Study type: Interventional

The goal of CELL-VAD Pilot trial is to investigate a personalized stem cell therapy approach for patients with advanced non-ischemic chronic heart failure (NICM) who are supported by LVAD. In the clinical trial, the investigators aim to enroll 10 patients with NICM, scheduled for LVAD implantation. After successful LVAD implantation, patients will be enrolled and followed for 2 months to allow for postoperative rehabilitation and heart failure medical therapy and LVAD support optimization. All patients will then undergo autologous CD34+ cell therapy which will be intracoronaryly delivered to the target myocardium using NOGA electromechanical mapping system. All patients will be followed for 6 months after cell therapy. At baseline, and at 1, 3, and 6 months after cell therapy, the investigators will perform comprehensive clinical evaluation.

NCT ID: NCT06149806 Recruiting - Clinical trials for Complex Congenital Heart Disease

National Registry of Adult Heart Failure Patients With Complex Congenital Heart Disease: Systemic Right Ventricle and Single Ventricle Treated With Sacubitril/Valsartan

Start date: July 1, 2021
Study type: Observational

Heart failure in adults with congenital heart disease is a major cause of morbidity and mortality. Patients with systemic right ventricle (SRV) and single ventricle (SV) are particularly at risk1, 2, 3. There are no specific recommendations for the management of heart failure in adults with congenital heart disease, whose management is based on "general cardiology" recommendations4,5. Sacubitril/Valsartan is validated as a treatment for heart failure in adults with acquired pathological left ventricular dysfunction (left ventricular ejection fraction (LVEF) < 40%, New York Heart Association (NYHA) functional class II and III despite optimal heart failure therapy)7. Although this molecule is used in current practice in patients with congenital heart disease, published data are limited 6-10. The aim of our work is to describe the efficacy and tolerability of Sacubitril/Valsartan in the treatment of chronic heart failure on VDS and VU through an observational, prospective, multicenter registry. The latest heart failure treatment guidelines, updated in 202111, recommend the addition of type 2 sodium-glucose co-transport inhibitors in heart failure patients with impaired ejection fraction (class IA recommendation). Two molecules are used in current practice: dapagliflozin and empagliflozin, at a single dosage of 10 mg/day. We will also be collecting data on the efficacy and safety of iSGLT2. It should be noted that, for practical reasons, there may be a delay between the end of the 1st study period (ISACC1) of one year and the start of the 2nd study period (ISACC2). Follow-up examinations carried out during the study period will not differ from those currently recommended in current practice5.

NCT ID: NCT06149195 Enrolling by invitation - Clinical trials for Rest Gated Myocardial Perfusion Imaging in Heart Failure

18F-MFBG Cardiac Imaging for Heart Failure Administration

Start date: January 1, 2024
Study type: Observational

The clinical feasibility of 18F-FMBG cardiac PET imaging will be observed in sympathetic nervous system activity in patients with heart failure, predicted cardiac events, guided ICD implantation, and evaluated therapy efficiency.

NCT ID: NCT06149104 Not yet recruiting - Heart Failure Clinical Trials

A Safety Study of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study

Start date: December 15, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this open-label study is to collect additional safety information of sacubitril/valsartan and to provide post-trial access to sacubitril/valsartan for the eligible Japanese patients who completed CLCZ696B2319E1 study until marketed product of pediatric formulation, film-coated granules in capsule, is available in Japan.

NCT ID: NCT06148935 Not yet recruiting - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

An Observational Study to Learn More About the Use of Vericiguat in Korean People With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) in Real-world Setting

Start date: November 30, 2023
Study type: Observational

This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in people with chronic heart failure with reduced ejection fraction (HFrEF). HFrEF is a long-term condition in which the heart does not pump blood as well as it should. Blood and fluid may collect in the lungs, blood vessels, and tissues causing shortness of breath or tiredness. Over time, heart failure can lead to other serious medical conditions that may result in hospital stays and death. The study treatment vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). sGC helps to regulate the heart and blood circulation. Vericiguat has already been studied in previous clinical studies and is available for doctors to prescribe to people with heart failure. This study will collect important data from real-world setting in Korea. The participants of this study are people with HFrEF who will receive vericiguat as prescribed by their doctors according to the approved product information. The main purpose of this study is to learn more about how safe vericiguat is in the participants. To do this, researchers will collect data on all medical problems (also called adverse events) that the participants have during the study. Doctors keep track of all adverse events, even if they do not think they might be related to the study treatment. Further, researchers will collect data on how well vericiguat works and treatment patterns in the participants. For this, the following information will be collected: - occurrence of death due to heart and circulatory events - hospital stays due to heart conditions (failure) - dose levels of vericiguat and duration of treatment The data for this study will come from medical records and visits that take place in routine practice. Participants will be treated with vericiguat and observed up to 12 months or until death or they leave the study, whatever comes first.

NCT ID: NCT06148571 Recruiting - Clinical trials for Left Ventricular Ejection Fraction Less Then or Equal to 50percent

Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal

Start date: October 10, 2023
Study type: Observational

While cardiac resynchronization therapy remains the mainstay for advanced HF, it is not always feasible due to unfavorable anatomy of coronary sinus or pacing characteristics. In such cases, left bundle branch area pacing itself or left bundle optimized cardiac resynchronization therapy could be a rescue therapy for failed or unsuccessful biventricular cardiac resynchronization therapy. However, the efficacy and safety of left bundle branch area pacing (or left bundle optimized cardiac resynchronization therapy) as rescue therapy for biventricular cardiac resynchronization therapy is largely hypothetic and lack concrete evidence still. Therefore, there is an unmet need for the registry purposed for left bundle branch area pacing among heart failure with mid-range (or mildly reduced) ejection fraction and heart failure with reduced ejection fraction patients to investigate its efficacy and safety. This study aims to investigate the efficacy and safety of left bundle branch area pacing in heart failure patients with ejection fraction below normal using Selectra catheters.

NCT ID: NCT06147336 Not yet recruiting - Heart Failure Clinical Trials

A Multi-center, National, Open-label, Prospective Study to Evaluate the Safety, Usability and Performance of the V-lap™ System

Start date: April 2024
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and performance of the V-LAP System in subjects with New York Heart Association (NYHA) functional class II and III HF, irrespective of left ventricular ejection fraction.

NCT ID: NCT06146803 Not yet recruiting - Clinical trials for Congestive Heart Failure

the "Level of Resilience" Influencing Self-care in Heart Failure Patients

Start date: November 20, 2023
Study type: Observational

Adaptation to the new health condition and self-care skills allow people to be able to adhere to the therapeutic treatment in the most correct way possible, but there are many cases in which subjects do not show adherence to it, and for this reason the risk increases to manifest acute complications and also to develop long-term ones

NCT ID: NCT06142903 Recruiting - Heart Failure Clinical Trials

Comparative Effectiveness of 7 Versus 21 Home-delivered Medically Tailored Meals to Improve Malnutrition Risk in Malnourished Patients With Heart Failure

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

This protocol is designed to compare the effectiveness of two dietary intervention doses for patients with heart failure (HF) and malnutrition risk or malnutrition at hospital discharge. This random order crossover design will provide evidence as to whether the provision of dinner meals alone versus all 3 daily meals to patients' homes is more effective at improving malnutrition risk score, and secondarily unplanned emergency department visits and readmissions.

NCT ID: NCT06142474 Recruiting - Ventilator Lung Clinical Trials

SGLT2 Inhibitors in Patients With ADHF During Ventilator Weaning

Start date: October 10, 2022
Phase: Phase 3
Study type: Interventional

This study will explore the potential benefits of sodium-glucose cotransporter 2 (SGLT2) inhibitors in preventing cardiac ischemia and cardiopulmonary edema in patients with acute decompensated heart failure during weaning from ventilators.