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Cardiomyopathy, Dilated clinical trials

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NCT ID: NCT06224660 Not yet recruiting - Clinical trials for DMD-Associated Dilated Cardiomyopathy

Modulation of SERCA2a of Intra-Myocytic Calcium Trafficking in Cardiomyopathy Secondary to Duchenne Muscular Dystrophy

MUSIC-DMD
Start date: March 2024
Phase: Phase 1
Study type: Interventional

This research study is testing whether an experimental drug, called SRD-001, is safe and helps the weakened heart of patients with Duchenne muscular dystrophy (DMD) regain its ability to effectively pump blood to the rest of the body. SRD-001 is a form of gene therapy. The goal of SRD-001 gene therapy is to provide the heart muscle cells with extra copies of the SERCA2a gene so that they can produce more SERCA2a protein to help the heart muscle cells squeeze/contract better. Researchers will compare SRD-001 treated participants with no-treatment participants; all participants will continue to take their current heart medications. All participants will be followed very closely for 2 years and undergo cardiac magnetic resonance imaging of their heart at baseline, year 1 and year 2 along with assessment of upper limb function and lung function. After the 2 years of close follow-up, all participants will roll over into long-term follow-up where they will be called biannually for information on their current medical status.

NCT ID: NCT06091475 Not yet recruiting - Heart Failure Clinical Trials

Therapy to Maintain Remission in Dilated Cardiomyopathy

TRED-HF2
Start date: October 20, 2023
Phase: N/A
Study type: Interventional

One third of patients diagnosed with heart failure demonstrate left ventricular reverse remodelling and recovery of cardiac function following a period of medical therapy. The TRED-HF trial investigated the impact of therapy withdrawal in this cohort and found that 40% of patients relapsed within 6 months of stopping treatment. In this follow-on study, the investigators will investigate the safety of therapy withdrawal of sodium cotransporter 2 inhibitors (SGLT2i) and mineralocorticord receptor anatagonists (MRAs) in patients with a previous diagnosis of heart failure and recovered cardiac function, in a randomised controlled trial to assess whether this maintains remission in this population.

NCT ID: NCT06072937 Not yet recruiting - Clinical trials for Pulmonary Arterial Hypertension

IntelliStent Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy

HEARTFUL-CHD
Start date: March 4, 2024
Phase: N/A
Study type: Interventional

IntelliStent is intended to achieve reduction of pulmonary hypertension, improvements in symptoms and quality of life in adolescent and adult patients with congenital heart disease and dilated cardiomyopathy.

NCT ID: NCT06039072 Not yet recruiting - Clinical trials for Cardiomyopathy, Dilated

Clinical Observation of Long-term Cardiac Function Prognosis in Patients With PPCM Who Have Recovered Cardiac Function

Start date: October 10, 2023
Phase:
Study type: Observational [Patient Registry]

Peripartum cardiomyopathy (PPCM) is an idiopathic cardiomyopathy that occurs in late pregnancy and early postnatal period, which is mainly characterized by varying degrees of impaired ventricular systolic function and symptoms related to heart failure, and is a serious threat to maternal health. About 50% of patients can achieve complete recovery of cardiac function within 6 months after diagnosis with early standardized treatment, about 30%-40% of patients can have delayed recovery, and about 12.6% of patients have long-term impairment of cardiac function and poor prognosis. However, there are still controversies about whether and when to stop the drug after standardized treatment. The Chinese Society of Cardiovascular Disease of the Chinese Medical Association proposed in the Guidelines for the Diagnosis and Treatment of Dilated Cardiomyopathy in China that patients with PPCM should be considered for gradual withdrawal of the drug after at least 1 year of stabilization of cardiac structure and function recovery. And in the China Heart Failure and Diagnostic and Treatment Guidelines released in the same year, it is proposed that standardized heart failure therapy for patients with peripheral cardiomyopathy should be continued until at least 6 months after the left ventricular function has been fully recovered before gradual discontinuation of the drug. The American Heart Association's 2019 guidelines for perinatal cardiomyopathy remain skeptical about the timing of discontinuation, with some experts suggesting that the drug can be gradually discontinued 1-2 years after cardiac function has recovered, while others still recommend long-term use of the drug to avoid deterioration of cardiac function after discontinuation. At present, there is a lack of large-scale clinical studies on the effect of stopping standardized treatment on the long-term prognosis of PPCM patients, and clarifying whether PPCM patients can discontinue the drug and the timing of discontinuation is of great significance to the long-term prognosis of the patients and even to the rational allocation of the national healthcare resources as a whole.

NCT ID: NCT05760924 Not yet recruiting - Heart Failure Clinical Trials

Left Bundle Branch Pacing on Outcomes and Ventricular Remodeling in Biventricular CRT Nonresponders

RESCUE
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Heart failure (HF) is the most common nosology encountered in clinical practice. Its incidence and prevalence increase exponentially with increasing age and it is associated with the increased mortality, more frequent hospitalization and decreased quality of life. An initial approach to the treatment of HF patients with reduced left ventricular (LV) systolic function and left bundle branch block (LBBB) was implantation of device for cardiac resynchronization therapy using biventricular pacing. This has resulted in long-term clinical benefits such as improved quality of life, increased functional capacity, reduced HF hospitalizations and overall mortality. However, conventional cardiac resynchronization therapy (CRT) is effective in only 70% of patients. And the remaining 30% of patients are non-responders to conventional CRT. Cardiac conduction system pacing is currently a promising technique for these patients. Particularly, His bundle pacing (HBP) has been developed to achieve the same results. According to other studies HBP has shown greater improvement in hemodynamic parameters comparing with conventional biventricular CRT. But, nevertheless, there are significant clinical troubles with HBP, especially high pacing threshold. In this regard, in 2017, the left bundle branch pacing (LBBP) was developed, which demonstrated clinical advantages compared to conventional biventricular CRT. Also, since 2019, left bundle branch pacing-optimized CRT (LBBPO CRT) has been used in clinical practice. These methods have become an alternative to HBP due to the stimulation of LBB outside the blocking site, a stable pacing threshold and a narrow QRS complex duration on electrocardiogram. A series of case reports and observational studies have demonstrated the efficacy and safety of LBBP and LBBPO CRT in patients with CRT indications. However, it is not enough data about impact of CRT with LBBP and combined CRT with LBBP and LV pacing on myocardial remodeling, reducing mortality and complications. According to our hypothesis, CRT with LBBP and combined CRT with LBBP and LV pacing compared with conventional biventricular pacing will significantly improve the clinical outcomes and reverse myocardial remodeling in patients who are non-responders to biventricular CRT with HF, reduced LV ejection fraction and with indications to CRT devices with defibrillator function (CRT-D) or one of the CRT-D leads replacement.

NCT ID: NCT05193838 Not yet recruiting - Clinical trials for Dilated Cardiomyopathy

Effect of Allopurinol on Left Ventricular Function in Children With Dilated Cardiomyopathy

Start date: May 1, 2022
Phase:
Study type: Observational

The aim of this study is to detect effect of allopurinol supplementation in pediatric patients with dilated cardiomyopathy.

NCT ID: NCT04860921 Not yet recruiting - Zinc Deficiency Clinical Trials

Zinc Deficiency in Dilated Cardiomyopathy

Start date: April 20, 2021
Phase:
Study type: Observational

The aim of this study is to detect effect of oral zinc supplementation in pediatric patients with dilated cardiomyopathy.

NCT ID: NCT04703751 Not yet recruiting - Clinical trials for Dilated Cardiomyopathy

Evaluation of the CIRCULATE Catheter for Transcoronary Administration of Pharmacologic and Cell-based Agents

Start date: September 2022
Phase: N/A
Study type: Interventional

Clinical evaluation of the CIRCULATE catheter involves intracoronary administration of a typical medical agent (nitroglycerin) and a shown-to-be-safe cell-based agent (CardioCell) in patients with a diagnosis of dilated cardiomyopathy (DCM).

NCT ID: NCT04139460 Not yet recruiting - Clinical trials for Cardiomyopathy, Dilated, 3B

CRT-P or CRT-D in Dilated Cardiomyopathy

CRT-REALITY
Start date: June 2020
Phase: N/A
Study type: Interventional

The ICD-Reality study is a non-commercial, investigator-led, multicenter, prospective, randomized, controlled trial. We aim to determine the effect of CRT-D or CRT-P implantation in non-ischemic cardiomyopathy and heart failure patients. The reason why we initiated this trial is the lack of evidence-based treatment for the significant number of these patients. In these patients, 5-year mortality remains as high as 20% despite recent therapeutic advances. Based on currently available evidence, because of a significant decrease in mortality due to modern pharmacotherapy, it is not certain which of these patients should receive a CRT-P and who should receive a CRT-D. No dedicated and adequately powered trial has addressed this important question. We hypothesize that patients with symptomatic HF, LVEF ≤35%, without left ventricular mid-wall fibrosis on LGE-CMR, will not benefit from CRT-D implantation compared with CRT-P only implantation. If our hypothesis is confirmed, this could provide evidence for the management of these patients with a significant impact on common daily praxis and health care expenditures. We aim to enroll 600 patients in the trial. 924 patients are needed to be screened for these 600 patients to be randomized. Patients with non-ischemic HF visiting an out-patient department and possibly eligible for the trial will have their pharmacotherapy optimized. Patients with a significant amount of fibrosis will be excluded from the study and treated according to local practice with an emphasis on ICD implantation to prevent SCD. After fulfilling all eligibility criteria, including maximally tolerated pharmacotherapy, subjects will be randomized by the physicians who enrolled them in a 1:1 ratio to receive CRT-D or CRT-P implantation. All patients will be followed-up for at least 3 years after the implantation.

NCT ID: NCT03993730 Not yet recruiting - Clinical trials for Dilated Cardiomyopathy

Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy

CMR GUIDE DCM
Start date: June 2020
Phase: N/A
Study type: Interventional

CMR GUIDE DCM is a randomized controlled trial with a registry for non-randomized patients. Patients enrolled will have non-ischemic cardiomyopathy (NICM) with mild to severe Left Ventricular (LV) systolic dysfunction with replacement fibrosis identified on Cardiac Magnetic Resonance (CMR). 954 patients will be randomised from 50 sites across 4-6 countries worldwide to receive an implantable defibrillator (ICD) or implantable loop recorder (ILR). Device and clinical follow-up will be performed at 3, 6, 12, 24, 36 months and at end of study.