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Heart Failure clinical trials

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NCT ID: NCT05636956 Recruiting - Heart Failure Clinical Trials

Education and Counseling Program on Patients With CIEDs and Low HL

Start date: June 26, 2022
Phase: N/A
Study type: Interventional

The goal of this RCT (randomized controlled trial) is to investigate the effect of education and counseling program that researches developed on patients with cardiac implantable electronic devices (CIEDs) and low health literacy. The main questions are; Is there a difference between the health literacy scores of intervention and control groups after education and counseling program? Is there a difference between the CIEDs knowledge scores of intervention and control groups after education and counseling program? Is there a difference between the daily life activity scores of intervention and control groups after education and counseling program? Researches offer an education and counseling program about living with CIEDs to patients that having CIEDs for the first time. Participants answers questions in Health Literacy Survey European Questionnaire 16, cardiac implantable electronic devices knowledge scale (researches developed) and Duke Activity Index before education and counseling program, at first month, third month and sixth month after implantation. Reseraches compare scores between intervention and control groups, also different times in same groups.

NCT ID: NCT05636176 Recruiting - Heart Failure Clinical Trials

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

HERMES
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

NCT ID: NCT05635331 Active, not recruiting - Heart Failure Clinical Trials

Real-world Dapagliflozin Experience in Patients With Heart Failure in Greece

EVOLUTION-HF
Start date: December 28, 2022
Phase:
Study type: Observational

Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality. Dapagliflozin has been approved by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in May 2020 and November 2020 respectively, for HF with reduced ejection fraction (HFrEF). The overall aim of this study is to describe the characteristics of patients initiating dapagliflozin for the treatment of HFrEF and to provide early insights into real-world dapagliflozin treatment patterns as well as patient-reported outcomes (PROs) including quality of life.

NCT ID: NCT05633784 Recruiting - Diabetes Mellitus Clinical Trials

Telemedicine Home-based Management in Patients With CHF and Type 2 Diabetes

TELEMECHRON
Start date: August 18, 2022
Phase: N/A
Study type: Interventional

The progressive ageing of the population of industrialized countries is accompanied by a dramatic increase in the prevalence of chronic multi-pathologies. In the general population, HF is associated with a higher prevalence of T2DM compared with patients without HF and with marked regional differences observed in Europe and the rest of the world. In clinical trials of chronic HF patients, the prevalence of T2DM is approximately 30% in patients with reduced or preserved ejection fraction and rises to as much as 45% in hospitalized patient registries. A complex drug regimen is often associated with low adherence in patients with HF and T2DM and poor adherence is associated with adverse clinical events. Similarly, adherence to recommendations regarding lifestyle changes, such as increasing physical activity, is often limited despite these changes' favourable effects on the patient. Therefore, interventions are needed to improve all these factors and optimize adherence. The inclusion of telemedicine (telenursing, telerehabilitation, mHealth) focused on health and correct behaviour can create opportunities to implement customized and scalable solutions in populations at risk. The project will aim to evaluate for patients with chronic diseases with a complex phenotype (heart failure and type II diabetes mellitus) the effectiveness of a remote surveillance program with particular attention to lifestyle changes.

NCT ID: NCT05633758 Withdrawn - Clinical trials for Acute Decompensated Heart Failure

Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure

MELT-HF
Start date: March 2014
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a multicenter double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to placebo in patients admitted with acute decompensated heart failure.

NCT ID: NCT05633290 Recruiting - Heart Failure Clinical Trials

CharacterisatiON of carDiac funCTion in Intensive Care Unit Survivors of Sepsis.

CONDUCT-ICU
Start date: March 1, 2023
Phase:
Study type: Observational

Cardiac dysfunction is common following hospital admission with sepsis and one of the most frequent causes for readmissions to hospital, however underlying mechanisms by which this might occur are unclear. The CONDUCT-ICU investigators will conduct a pilot, cohort study, characterizing cardiac function in ICU survivors of sepsis using a combination of CMR imaging, biomarkers and patient reported outcome measures to investigate mechanisms of cardiac dysfunction following sepsis. Comparisons will be made to that of the general population.

NCT ID: NCT05633004 Completed - Heart Failure Clinical Trials

Avicena LVDP Validation Study

Start date: September 27, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to determine the relationship between non-invasive measurement of left ventricular diastolic pressure (LVDP) using the Vivio System, compared with invasively measured LVDP via direct measurement during left heart catheterization.

NCT ID: NCT05632653 Not yet recruiting - Clinical trials for Coronary Artery Disease

CTO-PCI in Heart Failure Patients

CTO-HF
Start date: March 2023
Phase: N/A
Study type: Interventional

The study investigates wheather CTO-PCI improves survival and heart failure related rehospitalization compared to optimal medical therapy (OMT). This hypothesis will be investigated within a large-scaled international, representative, prospective, randomized, controlled, open-label, event-driven, multicentre trial (trial acronym: CTO - Heart Failure) recruiting patients with planned CTO-PCI.

NCT ID: NCT05632432 Recruiting - Clinical trials for Coronary Artery Disease

Atrial Appendage Micrograft Transplants to Assist Heart Repair After Cardiac Surgery

AAMS2
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Ischemic heart disease (IHD) leads the global mortality statistics. Atherosclerotic plaques in coronary arteries hallmark IHD, drive hypoxia, and may rupture to result in myocardial infarction (MI) and death of contractile cardiac muscle, which is eventually replaced by a scar. Depending on the extent of the damage, dysbalanced cardiac workload often leads to emergence of heart failure (HF). The atrial appendages, enriched with active endocrine and paracrine cardiac cells, has been characterized to contain cells promising in stimulating cardiac regenerative healing. In this AAMS2 randomized controlled and double-blinded trial, the patient's own tissue from the right atrial appendage (RAA) is for therapy. A piece from the RAA can be safely harvested upon the set-up of the heart and lung machine at the beginning of coronary artery bypass (CABG) surgery. In the AAMS2 trial, a piece of the RAA tissue is processed and utilized as epicardially transplanted atrial appendage micrografts (AAMs) for CABG-support therapy. In our preclinical evaluation, epicardial AAMs transplantation after MI attenuated scarring and improved cardiac function. Proteomics suggested an AAMs-induced glycolytic metabolism, a process associated with an increased regenerative capacity of myocardium. Recently, the safety and feasibility of AAMs therapy was demonstrated in an open-label clinical study. Moreover, as this study suggested increased thickness of the viable myocardium in the scarred area, it also provided the first indication of therapeutic benefit. Based on randomization with estimated enrolment of a total of 50 patients with 1:1 group allocation ratio, the piece of RAA tissue is either perioperatively processed to AAMs or cryostored. The AAMs, embedded in a fibrin matrix gel, are placed on a collaged-based matrix sheet, which is then epicardially sutured in place at the end of CABG surgery. The location is determined by preoperative late gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI) to pinpoint the ischemic scar. The controls receive the collagen-based patch, but without the AAMs. Study blood samples, transthoracic echocardiography (TTE), and LGE-CMRI are performed before and at 6-month follow-up after the surgery. The trial's primary endpoints focus on changes in cardiac fibrosis as evaluated by LGE-CMRI and circulating levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP). Secondary endpoints center on other efficacy parameters, as well as both safety and feasibility of the therapy.

NCT ID: NCT05632198 Not yet recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

The Effect of Uncertainty in Heart Failure

Start date: November 28, 2022
Phase:
Study type: Observational [Patient Registry]

This study was planned as a descriptive and correlational type study to reveal the effect of perceived uncertainty by heart failure (HF) patients with reduced ejection fraction on quality of life and self-care behaviors. In this study, which aimed to reach 122 inpatients with HF, the dependent variables were quality of life and self-care behaviors, the independent variable will be perceived uncertainty. Data will be collected by Mishel Uncertainty in Illness Scale-Community Form (MUIS-C), Left Ventricular Disfunction Scale (LVD-36) and European Heart Failure Self-Care Behavior Scale (EHFSeBS). Data analysis will basically be done with Multivariate Analysis of Variance (MANOVA).