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Heart Failure, Systolic clinical trials

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NCT ID: NCT06324682 Recruiting - Atrial Fibrillation Clinical Trials

ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing

TREEBEARD
Start date: January 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical practice of the participating centres. The contribution of non-fluoroscopic anatomical and electrophysiological reconstruction systems to device implantation procedures will also be evaluated. Participants [patients over 18 years old with an indication to receive a definitive pacemaker/intracardiac defibrillator implant] will receive a permanent cardiac pacing implant as requested according to European Society of Cardiology (ESC) guidelines; the investigators will evaluate procedural efficacy and safety of different implantation approaches.

NCT ID: NCT06121323 Recruiting - Clinical trials for Heart Failure, Systolic

Physiological Effects of Lactate in Individuals With Chronic Heart Failure

Start date: November 22, 2023
Phase: N/A
Study type: Interventional

Background: Lactate is continuously produced in the human body through two primary processes: glycolysis and microbial fermentation in the gastrointestinal tract. At rest, its concentration in the bloodstream typically ranges from 1 to 2 mmol/L. However, during periods of physical exertion or insufficient oxygen supply, such as during intense exercise, lactate levels significantly increase. Traditionally, lactate was perceived as a byproduct of anaerobic metabolism. Nevertheless, emerging research has illuminated its vital role as both a signaling molecule and a crucial energy source for vital organs like skeletal muscle, brain, and the heart. Objectives: The primary aim of this study is to investigate the impact of physiological levels of circulating lactate on the hemodynamics of individuals with chronic heart failure. This research seeks to understand how lactate affects the cardiovascular response in this specific patient population. Design and Endpoints: The study design employs a double-blind, randomized crossover approach involving 12 heart failure patients. Each participant will undergo two separate visits. Visit 1: Participants will receive a three-hour intravenous infusion of either a racemic (D/L) mixture of sodium lactate or an intravenous isotonic sodium chloride placebo, with a subsequent crossover to the opposite infusion on the same day. Visit 2: Similar to the first visit, participants will receive either an orally administered racemic (D/L) mixture of sodium lactate or an isocaloric, isovolumic oral placebo (maltodextrin), with a crossover to the opposite administration after three hours. The study's endpoints include cardiac output (primary), mixed venous saturation (SVO2), pulmonary wedge pressure, resting echocardiography (left ventricular ejection fraction and myocardial work efficiency), and measurements of vasoactive substances in blood samples. Methods: The study employs invasive Swan-Ganz monitoring to measure cardiac output, echocardiography, and frequent venous blood sample collections. These measurements and samples will be taken at specific intervals during the study visits. Intervention: To investigate the isolated hemodynamic and physiological effects of lactate, the study utilizes lactate infusion and ingestion to induce a state of hyperlactatemia within the physiological range. The intended dosages aim to stay within the physiological range, with no values expected to exceed 3-4 mmol/L.

NCT ID: NCT06108076 Recruiting - Type 2 Diabetes Clinical Trials

Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes

Start date: January 16, 2024
Phase: Early Phase 1
Study type: Interventional

This study will provide insight into whether cardiac function changes with oral Ketone Esters (KE) administered to patients with Type 2 Diabetes Mellitus (T2DM) and Heart failure with reduced ejection fraction (HFrEF). Plasma ketones are avidly extracted by cardiac muscle and their uptake is not dependent upon insulin or influenced by insulin resistance.

NCT ID: NCT06009276 Recruiting - Clinical trials for Overweight and Obesity

Associations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status

Start date: August 30, 2023
Phase:
Study type: Observational

The purpose of the study is to determine associations between fitness status, bacteria in the mouth, and the blood flow to muscle. This study is trying to find out if fitness status impacts the bacteria that are present in the oral microbiome (environment in the mouth) or the ability of the body to send blood to the skeletal muscle. Participants will complete all or some of the following: - A mouth swab to assess the bacteria in their mouths. - Produce a saliva sample into a tube. - Cycle on a bike until you reach maximum effort. - Undergo blood draws - Wear a 24-hour non-invasive device that monitors blood pressure. - Undergo a test to assess blood flow to the muscles measured with an ultrasound. - Drink 70mL (1/3 of a cup) of concentrated beetroot juice once

NCT ID: NCT05989945 Recruiting - Stroke Clinical Trials

HIDRAdenitis Suppurativa and HEART Disease

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

In a prospective observational cohort study (n = 250) the investigators aim to assess the correlation between cardiac biomarkers, advanced echocardiography and HS severity and determine whether these are prognostic markers of heart disease in patients suffering from hidradenitis suppurativa (HS).

NCT ID: NCT05949801 Recruiting - Clinical trials for Chronic Systolic Heart Failure

Evaluation of the Effect of Injectable Neucardin on Cardiac Function and Reversal Ventricular Remodeling in Patients With Chronic Systolic Heart Failure

Start date: April 13, 2023
Phase: Phase 3
Study type: Interventional

A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the effect of recombinant human Neuregulin-1 for injection on cardiac function and reverse ventricular remodeling in male patients with NT-proBNP ≤ 1700 pg/ml and female patients with NT-proBNP ≤ 4000 pg/ml and New York Heart Association class II-III chronic systolic heart failure, and to confirm its efficacy and safety.

NCT ID: NCT05933083 Recruiting - Clinical trials for Coronary Artery Disease

MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation

Start date: October 27, 2023
Phase: N/A
Study type: Interventional

Cardiac rehabilitation is a medically recommended program for patients with certain heart conditions. It includes exercise training, health education, and counseling. Unfortunately, many patients do not participate in cardiac rehabilitation. Some find it challenging to attend the in-person sessions. This study aims to compare two methods of delivering cardiac rehabilitation: in-person and through telehealth. The investigators want to know if the effects of these two programs are alike and if certain individuals benefit more from one program over the other.

NCT ID: NCT05928026 Recruiting - Quality of Life Clinical Trials

Financial Support in an Underserved and Low-Income Population With Heart Failure

FUND-HF
Start date: June 9, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test whether financial support in the form of a one-time $500 stipend would improve medication adherence and quality of life in low-income, socially-needy patients with heart failure with reduced ejection fraction in the post-discharge setting. The main questions it aims to answer are: - Will financial support improve heart failure quality of life? - Will financial support improve medication adherence? Participants will complete surveys on quality of life, social stress, and spending habits at their baseline visit. Participants will be randomly assigned to receive $500 at their baseline visit or $0 at their baseline visit. At their one month visit, quality of life and medication adherence will be assessed. These results will be compared between groups. The group that received $0 at their baseline visit will be provided $500 at their one-month visit and return for a two-month visit. At that visit, quality of life and medication adherence will be assessed. These results will be compared to their one-month results. Researchers will compare the 1-month quality of life scores and medication adherence scores between the immediate financial support vs delayed financial support. Researchers will also compare 1-month vs 2-month quality of life and adherence data for participants who were randomized to the delayed financial support group.

NCT ID: NCT05884411 Recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Evaluation of Left Bundle Branch Area Pacing As A Rescue Strategy for Cardiac Resynchronization Therapy Non-Response

Start date: April 30, 2023
Phase: N/A
Study type: Interventional

This study aims to investigate whether the investigators can improve heart function in patients with heart failure who have undergone cardiac resynchronization therapy, but have not had an improvement in their heart function at least one year after the procedure. The investigators will evaluate whether placing a new pacing lead (electrode) in a different part of the heart may increase heart function and decrease heart failure symptoms.

NCT ID: NCT05752760 Recruiting - Heart Failure Clinical Trials

Pilot Study Lp299v Supplementation in Chronic Heart Failure

Start date: February 20, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to determine the impact of 12 weeks of Lp299v supplementation (20 million cfu/day vs. placebo) on exercise capacity, circulating biomarkers of cardiac remodeling, quality of life, and vascular endothelial function in humans with heart failure and reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) who have evidence of residual inflammation based on an elevated C-reactive protein level. This will be done in the setting of a randomized, double-blind, placebo-controlled trial.