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Heart Failure clinical trials

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NCT ID: NCT05855135 Recruiting - Heart Failure Clinical Trials

Assessment of Combined CCM and ICD Device in HFrEF

INTEGRA-D
Start date: May 17, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%). Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.

NCT ID: NCT05851053 Recruiting - Heart Failure Clinical Trials

Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study

BLOC-II
Start date: September 1, 2022
Phase:
Study type: Observational

Rationale: In addition to surgery, effective breast cancer (BC) treatment typically requires chemotherapy, radiotherapy, or both. However, it is still unclear whether patients with BC are at increased risk of long-term cardiac dysfunction due to the adverse effects of these therapies. In a cross-sectional study in primary care, a comparison on cardiac dysfunction between 350 BC survivors and 350 age- and general practitioner (GP)- matched controls without cancer was made. In that study, BC survivors were at increased risk of mild systolic cardiac dysfunction (left ventricle ejection fraction (LVEF)< 54%). By contrast, there was no significant difference in an LVEF < 50% or in diastolic dysfunction. To date it remains uncertain whether the mild or subclinical dysfunction we observed predicts further cardiac deterioration. Consequently, the translation of these results into guidelines for the daily practice of the GP is unclear. Objective: The aim of the here proposed study is to clarify whether cardiac function in survivors of BC should be monitored by GPs, by assessing whether an unselected population of long-term BC survivors is at increased risk of developing cardiac dysfunction, whether in this group at-risk subgroups exists, and what factors are associated with the highest risk. Study design: A new assessment of cardiac function among women included in the BLOC-I study. This produces a longitudinal matched cohort design consisting of two cohorts in primary care. Study population: Survivors of BC, diagnosed ≥11 years ago who received chemotherapy and/or radiotherapy, and a matched reference population with no history of cancer. All participants participated in the Breast cancer Long-term Outcome of Cardiac function (BLOC-I) study. Main study parameters/endpoints: Left ventricular systolic dysfunction. Systolic cardiac dysfunction is defined as a LVEF <54/50/45%.

NCT ID: NCT05847244 Recruiting - Obesity Clinical Trials

The Effect of Addition of Metformin In Obese Non- Diabetic Patients With Heart Failure With Preserved Ejection Fraction

Start date: October 1, 2023
Phase: Phase 2
Study type: Interventional

Diabetes mellitus people have a higher incidence of cardiovascular disease, and the results of cardiovascular events are worse. Heart failure and diabetes both have a worse prognosis, with a 1.5-2 times increased risk of death. Data from the literature have shown that MET lowers mortality by 14-35% in this patient population, which represents one-third of all HF patients with no increases in lactic acidosis incidence.

NCT ID: NCT05841199 Recruiting - Clinical trials for Coronary Artery Disease

Coronary Flow During Rapid Heart Rates

VT flow
Start date: August 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the factors which determine how well ventricular tachycardia (VT) is tolerated. The main questions it aims to answer are: 1. What impact does coronary artery disease have on the ability for a patient to tolerate VT? 2. Does treatment of coronary artery disease with stents improve the tolerability of VT? Participants who are undergoing a clinically indicated coronary angiogram or coronary angioplasty procedure will have measurements of blood pressure, coronary pressure and coronary flow made during pacing at a range of heart rates.

NCT ID: NCT05839067 Recruiting - Heart Failure Clinical Trials

Supporting Health in Veterans With Heart Failure

CARE-HF
Start date: May 31, 2023
Phase: N/A
Study type: Interventional

This study will test the effectiveness of a culturally-sensitive, telephone-based, tailored problem-solving intervention to improve physical and mental health in Veterans with heart failure (HF). Veterans will be recruited from VA clinics throughout the United States. As a component of this study, Veterans will partner with a registered nurse for a 12-week telehealth program that includes 8 telephone sessions. Follow-up data will be collected at 3-months (post intervention) and 6-, 12-, and 18-months to examine sustainability of intervention effect.

NCT ID: NCT05838287 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants

PIOHF
Start date: July 10, 2023
Phase: Phase 4
Study type: Interventional

Our goal of the study is to learn the effects of the diabetes medication named Pioglitazone, in type-2 diabetic obese participants with Heart failure. The main question it aims to answer are: 1. To demonstrate that impaired mitochondrial function leading to reduced ATP generation plays a key pathophysiologic role in the development of heart failure with preserved ejection fraction (HFpEF) in obese type 2 diabetic (T2D) individuals. 2. To demonstrate that pioglitazone, improves diastolic (as well as systolic) function by improving myocardial insulin sensitivity and by reducing both myocardial and epicardial fat content.

NCT ID: NCT05837143 Recruiting - Heart Failure Clinical Trials

Myocardial Telomere Recapping Study for Dilated Cardiomyopathy

MERCURY-DCM
Start date: April 6, 2023
Phase: Early Phase 1
Study type: Interventional

The aim of this study is to determine the safety and feasibility of giving an adeno-associated viral vector expressing a modified telomerase protein (TERT), driven by cardiac troponin T promoter (AAV9-cTnT-modTERT), to 15 dilated cardiomyopathic patients.

NCT ID: NCT05836233 Recruiting - Right Heart Failure Clinical Trials

Predictive Value of Vasodilator Challenge for Right Heart Failure After LVAD Implantation

PREVV-RHF-LVAD
Start date: February 15, 2023
Phase:
Study type: Observational [Patient Registry]

Prospective evaluation of the predictive value for post-LVAD right ventricular failure (RHF) of pulmonary vasodilator challenge, in addition to current laboratory, echocardiographic and haemodynamic parameters. LVAD candidates satisfying the inclusion criteria will undergo vasodilator challenge with sodium nitroprusside (NTP) infusion following the study protocol. Thereafter, we will evaluate all data in order to determine which variables significantly correlate with RHF onset after LVAD implantation.

NCT ID: NCT05835024 Recruiting - Heart Failure Clinical Trials

Acorai MLG Study (Machine Learning Generalisation)

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

Acorai is developing a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters in patients with suspected or confirmed heart failure, and/or pulmonary hypertension, who require hemodynamic assessment. The device will be intended as a companion test or clinical decision support tool to be used and interpreted by qualified healthcare professionals to aid standard-of-care clinical assessment in identifying hemodynamic congestion and supporting personalized treatment of heart failure and pulmonary congestion. This study is part of the development of a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters. It will be conducted to collect the data needed to train the machine learning models retrospectively.

NCT ID: NCT05834803 Recruiting - Heart Failure Clinical Trials

Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.

DAN-PTRAII
Start date: June 26, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to document a beneficial effect of percutaneous transluminal renal angioplasty (PTRA) of atherosclerotic renal artery stenosis in high-risk patients selected according to the criteria used in the DAN-PTRA study. The main questions the trial aims to answer are if renal artery stenting compared with optimal medical treatment alone has beneficial effects on: - Blood pressure - Kidney function - Hospitalizations for heart failure