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Dilated Cardiomyopathy clinical trials

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NCT ID: NCT04159454 Completed - Heart Failure Clinical Trials

PITA-HF: Feasibility, Safety, and Tolerability

Start date: November 20, 2020
Phase: N/A
Study type: Interventional

Heart failure affects over 25 million people worldwide and nearly 7 million adults in the United States alone. Nearly 25% of patients with heart failure have worsened disease burden from dyssynchronous ventricular contraction due to abnormal electrical impulse propagation. These patients may benefit from cardiac resynchronization therapy (CRT) where contraction between the ventricles is coordinated by simultaneous electrical stimulation of the right and left ventricles. In animal models, CRT changes molecular and cellular biology by improving myofilament function, ion channel regulation, beta-receptor signaling, and overall mitochondrial energetics. In randomized clinical outcomes trials, the use of CRT further reduced the incidence of heart failure events and improved overall mortality. However, nearly 75% of patients with heart failure have synchronous ventricular contraction and therefore do not qualify for CRT. CRT profoundly alters underlying molecular and cellular biology as a result of the transition from dyssynchronous to resynchronized contraction, enhancing myocyte function and adrenergic responsiveness. The investigators previously hypothesized CRT-like benefits could be achieved in otherwise synchronous heart failure by purposely inducing dyssynchrony for several hours each day and then reversing this for the remainder of the time. The investigators termed this pacemaker induced transient dyssynchrony, or PITA, and tested its impact in a canine dilated cardiomyopathy model. Following several weeks of rapid atrial pacing to induce heart failure in the animals, the investigators compared implementing 4-weeks of PITA - consisting of dyssynchronous rapid right ventricular pacing for 6 hours each night and atrial pacing for the remaining time - to animals that always received rapid atrial pacing. The fast rate is used to generate a heart failure phenotype. PITA improved chamber dilation, increased beta-adrenergic responsiveness and contractile function, and improved myofiber structure compared to heart failure canine controls. While first tested in an intact conscious translational model, no study has yet investigated PITA in humans. This pilot research protocol tests the feasibility, safety, and tolerability of PITA in humans with dilated cardiomyopathy. The study will leverage pre-existing Medtronic (Mounds View, MN) pacemaker/defibrillators implanted in dilated cardiomyopathy patients based on current clinical guidelines. If successful, this study will allow for a larger, first-in-human study to assess indexes of left ventricular function in dilated cardiomyopathy patients with PITA.

NCT ID: NCT04146701 Recruiting - Sepsis Clinical Trials

Metabolomics and Microbiomics in Cardiovascular Diseases

MEMORIA
Start date: February 1, 2019
Phase:
Study type: Observational [Patient Registry]

"MEtabolomics and MicrObiomics in caRdIovAscular diseases Mannheim (MEMORIAM) " is a single-center, prospective and observational study investigating to identify disease-specific metabolic, respectively microbiomic, patterns of patients with high-risk cardiovascular diseases. High-risk cardiovascular diseases comprise patients suffering from acute heart failure (AHF), ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), sepsis, septic shock, ischemic and non-ischemic cardiomyopathy.

NCT ID: NCT04055636 Recruiting - Heart Failure Clinical Trials

Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy.

PROMETEY
Start date: June 14, 2019
Phase:
Study type: Observational

Advances in treatment have led to improved survival of patients with cancer, but have also increased morbidity and mortality due to cancer treatment side effects. Cardiotoxicity is one the most frequent side effect which may lead to premature morbidity and death among cancer survivors. The most concerning cardiovascular complications of cancer therapy is myocardial dysfunction, leading to heart failure, and fatal arrhythmias, especially those induced by QT-prolonging drugs. PROMETEY (PROspective Multidisciplinary obsErvational Trial of cardiotoxicity in patiEnts undergoing anticancer therapy) - is Russian multicenter observational study assessing cardiotoxicity and its clinical, biochemical and genetic factors in patients on cancer therapy. The objectives of the study are: - to reveal prevalence of cardiotoxic effects of cancer therapy in routine clinical practice in Russian Federation, - to assess contribution of these effects to mortality of patients on cancer therapy, - to evaluate clinical and economic consequences of cardiotoxicity in patients with cancer, - to develop an individualized model of cardiotoxicity risk factors based on clinical and laboratory parameters. Patients: 400 cancer patients with toxic cardiomyopathy and 100 patients with idiopathic or family dilated cardiomyopathy. Study duration: 60 months. All patients will undergo complex examination after signing informed consent form(ICF): physical exam, echocardiography with speckle tracking analysis, ambulatory 48-hours ECG monitoring, biochemistry, analysis of biomarkers of myocardial injury, fibrosis and inflammation. Primary endpoint: all-cause mortality, heart transplantation, cardioverter-defibrillator implantation, hospitalization with heart failure decompensation. Secondary endpoints: - thromboembolism, - fatal/ nonfatal myocardial infarction, stroke, - sudden cardiac death, - surgical therapy of heart failure or arrhythmias, - cardiovascular death, - all-cause mortality, - heart transplantation, - cardioverter-defibrillator 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.

NCT ID: NCT03893760 Completed - Heart Failure Clinical Trials

Assessment of Right Ventricular Function in Advanced Heart Failure

Start date: October 2016
Phase:
Study type: Observational

We examined the feasibility and reliability of a combined echocardiographic and right heart catheterization (RHC) approach for right ventriculo/arterial (R-V/A) coupling assessment in HF patients with dilated cardiomyopathy (D-CMP).

NCT ID: NCT03843255 Recruiting - Clinical trials for Cardiovascular Diseases

Defining the Genetics, Biomarkers and Outcomes for Dilated Cardiomyopathy

Go-DCM
Start date: January 9, 2020
Phase:
Study type: Observational

Finding new ways to diagnose and treat Dilated Cardiomyopathy (DCM) could improve the health and well-being of patients with this condition. The main aim of this research study is to help develop better ways of diagnosing and treating patients with DCM. The information that is collected may help develop tailored treatments for patients with this disease in the future. This research study will recruit patients with DCM from a number of centres across England and follow their health over a period of years. Patients will give some blood samples for a type of genetic test called whole genome sequencing (WGS) to look for genetic changes. Patients will also have a magnetic resonance imaging (MRI) scan of their heart to look for any changes in the heart such as scarring, and check their heart function. The aim of this study is to discover if using WGS and MRI can improve the diagnosis of DCM. Another aim of the study is to look at how genetic changes and scarring in the heart may affect the progress of the disease. Studying patients with DCM may also help the investigators learn more about diagnosing and treating other diseases of the heart. The second aim of this study is to see whether using WGS and MRI scanning can also be useful in other types of heart diseases which might be affected by genetic changes or scarring in the heart.

NCT ID: NCT03775070 Completed - Clinical trials for Dilated Cardiomyopathy

Simvastatin Therapy in Patients With Dilated Cardiomyopathy.

SavDCM
Start date: January 17, 2019
Phase: Phase 2
Study type: Interventional

Dilated cardiomyopathy (DCM) is the most common childhood cardiomyopathy and is associated with significant early morbidity and mortality. About half of patients die or require heart transplantation within 5 years of diagnosis. The medical therapy for DCM with heart failure includes anti-congestive medications and antiplatelet therapy. Those who fail to improve within the first year of diagnosis usually deteriorated even upon aggressive anti-congestive medications. The investigators had conducted precision-medicine-based approach to provide strategic approach as drug repurposing to identify new treatments. The investigators have identified the beneficial effects from a statin, simvastatin, to restore the cardiac contractility. The investigators would further assess the efficacy of simvastatin to improve the cardiac function in patients with DCM.

NCT ID: NCT03607669 Completed - Clinical trials for Hypertrophic Cardiomyopathy

Manganese-Enhanced Magnetic Resonance Imaging of the Myocardium

Start date: June 1, 2018
Phase:
Study type: Observational

Scanning the heart using magnetic resonance imaging (MRI) enables detailed assessment of its structure and function. MRI can give more detailed information about the heart by using a contrast 'dye' that is injected into a vein during the scan. This can highlight abnormal areas within the heart. Current contrast dyes help identify scarring within the heart, which is useful in people who have had heart attacks. The investigators plan to test new contrast dye containing manganese, which works differently to current agents. They believe it will provide unique insight into how the heart works. There are many different causes of heart problems and the investigators plan to use this new contrast agent to scan three patient groups; (i) heart disease caused by heart attacks, (ii) heart disease with abnormal thickening of the heart muscle, and (iii) heart disease where the heart becomes stretched and enlarged. Healthy volunteers will be scanned for comparison. The study will be carried out at the Royal Infirmary of Edinburgh. Adults between 18 and 65 with stable heart failure can be considered. Women who may be pregnant are unable to participate, as is anyone who has some types of metal in their body, as these people can't have an MRI scan safely. All participants will have 2 MRI scans lasting about an hour each, at least 2 days apart. Some participants will be have 4 MRI scans, over a longer time period. The investigators will also take some blood samples and record a tracing of the heart rhythm and will ensure there are no abnormal side-effects by telephone follow up. The investigators believe this new agent has potential to better measure disease in the heart, improve the ability to establish the cause of heart disease and help monitor the disease over time as well as guide future treatment for individual patients.

NCT ID: NCT03572660 Recruiting - Clinical trials for Dilated Cardiomyopathy

Use of Bone Marrow Derived Stem Cell and G-CSF With Circulatory Assistance in the Treatment of DCM

DCM-Support
Start date: December 24, 2018
Phase: Phase 2
Study type: Interventional

DCM Support is recruiting patients with dilated cardiomyopathy and heart failure symptoms. The goal of this clinical trial is to examine whether treatment with a patient's own stem cells can improve their heart function and alleviate heart failure symptoms. - Stem cells will be collected from bone marrow in the patient's hip under local anaesthetic. - The stem cells will be infused into the arteries that supply blood to the heart under local anaesthetic. - A mini heart pump will be used to take the strain off the heart during the procedure. - The follow-up involves a phone call at 1 month and clinic visits at 3 and 12 months

NCT ID: NCT03572569 Recruiting - Clinical trials for Hypertrophic Cardiomyopathy

Risk Stratification in Children and Adolescents With Primary Cardiomyopathy

RIKADA
Start date: January 2013
Phase:
Study type: Observational

RIKADA is a prospective study performing systematic family screening including clinical and genetic testing in pediatric patients with primary cardiomyopathy and their first-degree relatives with the aim to facilitate risk stratification.