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Heart Failure clinical trials

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NCT ID: NCT06166654 Not yet recruiting - Acute Heart Failure Clinical Trials

Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload

DRAIN-AHF
Start date: April 1, 2024
Phase: Phase 4
Study type: Interventional

Aim to identify the best strategy for treating acute heart failure (AHF) with volume overload, particularly focusing on patients resistant to standard loop-diuretics. The trial is a double-blinded, randomized, controlled, multicenter study. Its primary objective is to compare the efficacy of loop-diuretics combined with either Metolazone or Acetazolamide, against loop-diuretics alone. The trial will also determine the optimal type of loop-diuretic to use. Eligible participants include adults over 18 years hospitalized with AHF and volume overload, showing signs of congestion and at risk of diuretic resistance. Exclusions apply to those with acute coronary syndrome, low systolic blood pressure, prior renal therapy, or previous treatment with Acetazolamide or Metolazone. The primary outcome is the number of days alive and out-of-hospital by day 30. Secondary outcomes include a composite clinical benefit at 30 days, Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, and successful decongestion 72 hours post-inclusion. The trial aims to enroll about 1,041,939 patients across three treatment arms over three years. The minimal important difference is set as a reduction in out-of-hospital days by at least two days, with an anticipated low dropout rate. The study's power is calculated to be 80% with an adjusted alpha level for comparing the three diuretic groups.

NCT ID: NCT06161987 Recruiting - Clinical trials for Acute Decompensated Heart Failure

EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF

EACH-ADHF
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

EACH-ADHF: Early Comprehensive Rehabilitation in patients with ADHF study is a multi-center, parallel-group, randomized controlled trial designed to evaluate the effects of the early comprehensive rehabilitation including exercise and inspiratory muscle training, over a period of 6 weeks, on the quality of life of patients with ADHF.

NCT ID: NCT06161649 Recruiting - Clinical trials for Acute Decompensated Heart Failure

Mobile Education System to Improve Disease Knowledge, Self-efficacy and Quality of Life in Patients With Heart Failure

Start date: November 21, 2023
Phase: N/A
Study type: Interventional

Heart failure (HF) is an incurable and complex disease syndrome with sophisticated disease trajectories. The guideline for HF management suggests that treatment should include adequate education to help patients have better self-management ability, and improve their quality of life and prognosis. However, how to provide massive amount of HF patients a continuous, complete and individualized disease care education from hospitalization, post-discharge, to home for months is a difficult problem. This study plans to develop an automated and intelligent education system for HF on the mobile device "Line" platform. Through this platform, we hope to make the HF education continuous for 3 months from hospital to post-discharge period. We hypothesize that (1) this intervention can improve knowledge, self-care, emotional stress, self-efficacy, quality of life and disease outcomes in patients of HF; (2) the system developed in this study can reduce the hours of nursing work while improve the quality of education and become the best clinical auxiliary education tool.

NCT ID: NCT06161402 Recruiting - Heart Failure Clinical Trials

Elastic Band-Progressive Resistance Training (EB-PRT) for Sarcopenia Among Heart Failure Patients

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Heart failure (HF) is a complicated clinical syndrome caused by structural and/or functional cardiac abnormalities that result in ineffective myocardial pumping. HF management has placed more emphasis on improving the prognostic factors which determine these poor clinical outcomes. More recently, the prognostic role of sarcopenia in HF has received particular attention. Defined as progressive and generalized decline in skeletal muscle mass, strength and physical performance due to aging, sarcopenia is definitely a common comorbid of HF which follows an age-specific disease epidemiology. Given muscle disuse is the most preventable and reversible factor of sarcopenia, more evidence points to the therapeutic value of resistance training (RT) for this debilitating condition. Nevertheless, the therapeutic effects of RT on improving sarcopenia and thereby the disease prognosis among HF patients is yet to be evaluated. Therefore, the sequential mixed method study including a pilot RCT will be conducted to evaluate the preliminary effect of a 14-week elastic band-progressive resistance training (EB-PRT) and a subsequent qualitative study to explore the subjects' engagement experience. The outcomes cover the whole set of defining characteristics including muscle mass, muscle strength and functional performance and the clinical outcomes which reflect HF disease severity and patient-reported HRQL.

NCT ID: NCT06158711 Not yet recruiting - Heart Failure Clinical Trials

Real-world Research : Assessment of Effect of Combination of Drugs in the Treatment of Heart Failure

Start date: November 30, 2023
Phase:
Study type: Observational

The goal of this observational study is to assess the effect of the different combination of drugs in the treatment of heart failure. The main questions it aims to answer are: - [question 1] The changes of BNP and LVEF in patients of each groups with different drugs co-administration. - [question 2] The days of hospitalization, degree of lower limb edema (mild, moderate, severe) and 6-minute walking test in each groups. Participants will be asked to do nothing. All the records of the patients will be download from the Big Data Cloud Platform of Health Care in the First Affiliated Hospital of Shandong First Medical University. There is not a comparison group.

NCT ID: NCT06158698 Recruiting - Heart Failure Clinical Trials

CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine

CMP-MYTHiC
Start date: November 14, 2023
Phase: Phase 3
Study type: Interventional

Two-parallel groups randomized, single-blinded, multi-center phase III controlled trial in patients with chronic inflammatory cardiomyopathy to assess the efficacy of colchicine and associated prospective registry to assess the prognostic value of positive genetic testing in this population.

NCT ID: NCT06158633 Not yet recruiting - Dialysis Clinical Trials

A Pilot Observation and Feasibility Study of Prevora, Integrated Into Homecare Visits of High-risk Adults

Start date: December 2023
Phase:
Study type: Observational

Prevora is an antiseptic medication and dental treatment approved by Health Canada for reducing root decay (cavities) in adults at high risk of dental decay. An antiseptic kills germs and harmful bacteria. Prevora is applied to the teeth and gumline by a medical professional, takes about 10 minutes and is painless. Participating site(s) have a homecare program and usual care includes offering patients home care services before discharge from the hospital for some chronic diseases. Usual care includes home visits by a nurse and or personal support worker (PSW). The aim of this study is to explore the effectiveness, health benefits and feasibility of delivering preventive oral healthcare with Prevora, during a homecare visit by a nurse or PSW. All consenting and eligible subjects will continue with their usual care with the homecare program. The study is 5 months long. Subjects will have a Prevora treatment applied by the homecare nurse or PSW on Day 1, 14 days, 3 months and 4 months. The study includes several follow up visits which will be conducted in the patient's home and or by telephone or videoconferencing if needed. Oral exams, lab tests and subject completed questionnaires will be collected for the study. Changes in medications and any possible side effects will also be monitored during the study.

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: 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
Phase:
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.