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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

CELL-VAD
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

ISACC
Start date: July 1, 2021
Phase:
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: 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
Phase:
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: 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.

NCT ID: NCT06140914 Recruiting - Heart Failure Clinical Trials

Biological Mechanisms Behind Resynchronization Therapy in Heart Failure

Start date: March 15, 2023
Phase:
Study type: Observational

Heart failure is a common disease, affecting 2-3% of the population in the western world. About 30% of patients with heart failure and reduced ejection fraction display signs of electrical dyssynchrony on ECG, usually left bundle branch block (LBBB), which is associated with a worse prognosis. Cardiac resynchronization therapy (CRT) reduce mortality for patients with dyssynchronic heart failure, defined as ejection fraction (EF) = or < 35% and LBBB. About 1/3 of the patients that fit CRT criteria will not respond to CRT. Which patients that will turn out to be non-responders cannot be anticipated beforehand. We have started a clinical study to collect blood samples, heart tissue and clinical data from heart failure patients eligible for CRT and a control group of heart failure patients on medical therapy. Patients will be assessed before CRT implantation or early after initiation of medical treatment, at 3 months, 6 months and 12 months. Blood samples and tissue will be analysed in the search for (i) biomarkers to separate CRT responders from non-responders and (ii) mechanisms behind the remodelling observed in CRT and with medical therapy.

NCT ID: NCT06140251 Recruiting - Heart Failure Clinical Trials

Investigation of Biomarker Response to SGLT2 Inhibition in Heart Failure

SiN-HF
Start date: August 21, 2023
Phase:
Study type: Observational

This is a 26-week, open label, single-arm prospective evaluation of the effects of sodium glucose cotransporter 2 (SGLT2) inhibition on cardiac biomarkers, myocardial remodeling and patient reported outcomes in heart failure with both impaired and preserved left ventricular fraction.

NCT ID: NCT06137885 Recruiting - Heart Failure Clinical Trials

REgiStry-based Cardiovascular qUality improvEment Research

RESCUER
Start date: April 24, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this registry-based observational study is to establish a comprehensive management plan, which focus on medical therapy, cardiac rehabilitation and active post-market surveillance of medical devices, in patients with cardiovascular diseases (CVD). Patients with CVD mainly refers to four groups of patients´╝Ü1) post-percutaneous coronary intervention (post-PCI) patients; 2) patients with heart failure (HF); 3) patients with cardiometabolic diseases (CMD); 4) patients with structural heart disease (SHD), and the detailed definition of each group can be found in "Eligibility" section. The main questions this study aims to answer are: - the effectiveness of exercise-based cardiac rehabilitation in improving cardiac function, reducing CVD recurrence and mortality, and promoting quality of life for patients with CVD; - the feasibility of registry-based active post-market surveillance of high-risk medical devices used in cardiovascular surgeries, such as PCI, heart valve replacement, and cardiac resynchronization therapy (CRT); - the utilization of multiomics datasets to identify and dissect cardiovascular heterogeneity in both healthy and diseased populations and to guide precision medicine in patients with CVD; - the analysis and evaluation of the prescription patterns and drug response in patients with CVD.

NCT ID: NCT06130319 Recruiting - Clinical trials for Chronic Heart Failure

Correlation of Disease Management and Quality of Life in Patients With Chronic Heart Failure and Their Family Caregivers

Start date: November 2023
Phase:
Study type: Observational

This study intends to investigate the current status of disease management and quality of life of patients with chronic heart failure and their family caregivers, explore the relationship between the two sides of disease management and quality of life, help nurses identify the influencing factors of quality of life of patients with chronic heart failure and their family caregivers, and carry out family-centered care in the future. This study intends to investigate the current status of disease management and quality of life of patients with chronic heart failure and their family caregivers, explore the relationship between disease management and quality of life of both sides, and help nurses identify the influencing factors affecting the quality of life of patients with chronic heart failure and their family caregivers, so as to carry out family-centered care in the future. To provide theoretical basis for improving the quality of life of both parties.

NCT ID: NCT06126081 Recruiting - Heart Failure Clinical Trials

Clinical Efficacy of Early Left Bundle Branch Pacing for Cardiac Resynchronization Therapy

Early-RESYNC
Start date: June 26, 2023
Phase: N/A
Study type: Interventional

This is a two-center, prospective randomized controlled trial. The aim of this study is to compare the clinical efficacy of early left bundle branch pacing for cardiac resynchronization therapy and guideline-directed medical therapy in heart failure with mild-reduced ejection fraction.