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Heart Failure clinical trials

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NCT ID: NCT03781427 Recruiting - Clinical trials for Chronic Heart Failure

Tailoring Pacemaker Output to Physiology in Chronic Heart Failure

Start date: February 1, 2020
Phase: Phase 3
Study type: Interventional

Aims: To explore the clinical effect on exercise tolerance and quality of life, safety and tolerability of pacing at higher outputs in patients with chronic heart failure and a pacemaker. Background: Heart failure (HF) is a very common condition of breathlessness or fatigue associated with heart muscle weakness. In around 30% of people with HF, a pacemaker-based treatment known as cardiac resynchronization therapy (CRT) can improve symptoms and prognosis by retuning the timing of the contraction of the heart. However, the effect of CRT is variable and unpredictable, with around 1 in 3 of people obtaining no obvious symptomatic benefit. One of the reasons for this might be that the pacemaker pulse does not activate all of the heart muscle cells at the same time or at all. In order to provide the longest possible battery life span, the default programming for all pacemakers is to provide a stimulus at an arbitrary level above the capture threshold (at which the spike leads to contraction). Whilst this is reasonable in a normal heart where the aim is to treat a slow heart rate, in heart failure, where the aim is to retune all parts of the heart, it is possible that this is not enough to provide consistent contraction of all heart muscle cells. It is possible that providing a higher output electrical signal from the pacemaker will activate more of the heart muscle cells immediately and thereby improve the contraction of the heart. The investigators think that this might be important at rest, but even more important during activity. This concept has never been tested before in a systematic manner but could have large implications for people with heart failure and existing CRT devices which could simply be reprogrammed to derive greater benefits for patients during everyday activities. Design: The proposed project has two parts: Study 1 - 105 patients with a CRT pacemaker for heart failure but ongoing symptoms will be invited to attend the National Institute of Health Research Clinical Research Facility. Symptoms, medication, hospitalisation information will be collected and a heart ultrasound scan using the pacemaker to increase the heart rate will be done to describe the force frequency relationship. Patients will perform a cardiopulmonary exercise test. Of these patients, 40 will be invited to return for two further visits, to perform an exercise test each time with the pacemaker programmed to its usual output or high output pacing. At each visit, including the heart scans, the order of the programming will be random, and neither the observer nor the patient will know how the device has been programmed. Study 2 - 70 patients will be invited to participate in a longer term study of whether high output pacing is safe, well tolerated and has effects on walk time (on a treadmill) and heart pumping function. Participants will be randomly allocated to one of two groups: high output or standard pacemaker settings. In the high output group, the pacemaker will be programmed to deliver the highest output possible or tolerated. In the standard care group patients will have standard output settings.

NCT ID: NCT03775577 Recruiting - Clinical trials for Heart Failure With Normal Ejection Fraction

Exercise Intolerance in Heart Failure

Start date: April 1, 2017
Phase:
Study type: Observational

The investigators are studying whether metabolic abnormalities in cardiac and skeletal muscle in patients with heart failure with preserved ejection fraction (HFpEF) are associated with debilitating exercise intolerance.

NCT ID: NCT03772275 Recruiting - Heart Failure Clinical Trials

Utility of Some Novel Biomarkers of Patients With Chronic Heart Failure

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Clinical and Economic study of some new biomarkers in chronic heart failure.

NCT ID: NCT03771209 Recruiting - Heart Failure Clinical Trials

The "ABCDE" Score as a Five-step Vascular Ultrasound Examination in Heart Failure

Start date: April 26, 2018
Phase: N/A
Study type: Interventional

Heart failure (HF) is a clinical syndrome caused by structural and/or functional cardiac abnormalities, resulting in a reduced cardiac output and/or elevated intra-cardiac pressures at rest or during stress. It is the leading cause of hospitalization in Internal Medicine departments. This study aims at exploring evidence of the importance of ultrasound in HF both for hospitalized patients and in the follow up. Ultrasound may be used as a recovery monitoring instrument at the bedside and also as a global cardiovascular assessment tool for these patients. HF represents an exciting opportunity to create an integrative ultrasound approach in Internal Medicine/Geriatric departments.The Authors plan a five-step ultrasound examination to evaluate and monitor HF patients during hospitalization and follow-up. They call this examination: the "ABCDE" score. It includes the evaluations of A, the Ankle-brachial index (ABI), B, the B-lines, C, the Carotid intima media thickness (CIMT), D, the Diameter of the abdominal aorta and of the inferior cave vein and E, the echocardiographic assessment of the ejection fraction.This score represent an integrative ultrasound approach in Internal Medicine/Geriatric departments.

NCT ID: NCT03764722 Recruiting - Clinical trials for Systolic Heart Failure

Effectiveness of a Repetitive Use of 24-hour Levosimendan Infusions in Patients With Severe Systolic Heart Failure in Order to Prevent Rehospitalizations

Start date: August 1, 2018
Phase: Phase 4
Study type: Interventional

Rehospitalizations due to exacerbation of chronic heart failure are an important problem for patients suffering from heart failure. Rehospitalzations lead to worse prognosis, have an impact on the quality of life and have a negative financial impact on the health care system. Currently, studies are being conducted on the efficacy of levosimendan in the prevention of heart failure exacerbations. Patients receive levosimendan at repetitive use and preliminary results suggest a reduction in the incidence of exacerbations of heart failure. Thanks to the clinical trial planned in the Department of Cardiology of the Biziel Hospital with repeatable use of levosimendan, it is possible to determine the benefits of this method of treatment more accurately.

NCT ID: NCT03763136 Recruiting - Heart Failure Clinical Trials

Treating Heart Failure With hPSC-CMs

HEAL-CHF
Start date: October 8, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Heart failure has a high morbidity and mortality because the heart is one of the least regenerative organs in the human body. Drug treatments for heart failure manage symptoms but do not restore lost myocytes. Cellular replacement therapy is a potential approach to repair damaged myocardial tissue, restore cardiac function, which has become a new strategy for the treatment of heart failure. The purpose of this study is to assess the safety, feasibility and efficacy of intramyocardial delivery of cardiomyocytes at the time of coronary artery bypass grafting in patients with chronic heart failure.

NCT ID: NCT03753412 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Recovery From ICUAW Following Severe Respiratory and Cardiac Failure

CLEVERER
Start date: April 9, 2019
Phase:
Study type: Observational

To observe and identify determinants of recovery from intensive care unit-acquired weakness (ICUAW) following a severe cardiorespiratory failure requiring extra-corporeal membrane oxygenation (ECMO). Additionally, to discover the effects of ICUAW on physical function and health-related quality of life (HRQoL) after critical illness. CLEVERER is a clinical observational pilot study.

NCT ID: NCT03749343 Recruiting - Clinical trials for Coronary Artery Disease

International T1 Multicenter Outcome Study

T1Outcome-DE
Start date: March 1, 2016
Phase:
Study type: Observational

Mapping of magnetic relaxation within the myocardial tissue using T1 (and T2) mapping using cardiovascular magnetic resonance (CMR) are novel measures of quantifiable (scalable) myocardial tissue characterisation. Evidence suggests that myocardial mapping could be useful in detection of diffuse myocardial disease, complementing late gadolinium enhancement (LGE) as the tool for regional myocardial disease. A handful of studies, three single centre study of a single T1 index with outcomes and one multicentre study for all indices reported strong associations with all cause mortality and heart failure. These studies were based on a single-vendor platform and were using a single sequence. The main unknowns pertaining the successful translation of this technique and the transferability of the methodology beyond a single centre and lack of outcome evidence from broad and large populations. In this study, we will assess the diagnostic accuracy of T1 (and T2) mapping measurements in health and disease, and the prognostic relevance of T1 mapping measurements by associations with outcome. This study is builds upon/integrates the evidence of the NCT02407197 study, which remains active for follow-up, but is currently no longer recruiting.

NCT ID: NCT03746938 Recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

First in Humans to Evaluate Collagen Patches With Stem Cells in Patients With Ischemic Left Ventricular Dysfunction

CARDIOMESH
Start date: November 13, 2018
Phase: Phase 1
Study type: Interventional

It´s a first open-label trial in humans to evaluate the safety and efficacy of epicardial delivery of collagen patches with adipose-derived stem cells in patients with ischemic heart disease and left ventricular dysfunction that remain symptomatic despite optimal medical treatment.

NCT ID: NCT03727828 Recruiting - Heart Failure Clinical Trials

Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure

Start date: November 15, 2018
Phase:
Study type: Observational

The objective of this work is to investigate and then to sequence new biomarkers in the blood of patients with heart failure, and study their diagnostic, risk stratification and prognostic value.