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Heart Failure, Systolic clinical trials

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NCT ID: NCT06434025 Not yet recruiting - Clinical trials for Heart Failure, Systolic

IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency

COMBINED-HF
Start date: May 24, 2024
Phase: Phase 3
Study type: Interventional

Background. Treatment with intravenous iron has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. However, the mechanisms underlying these beneficial effects remain unknown. SGLT2i seem to alter hematocrit and other hematological markers or iron content. This study aims to measure cardiac magnetic resonance changes in myocardial iron content and in left ventricular function after administration of intravenous iron with and without the concomitant use of SGLT2 inhibitor in patients with HFrEF and iron deficiency.

NCT ID: NCT06336746 Not yet recruiting - Clinical trials for Heart Failure, Systolic

Effects of Steep Trendelenburg and Pneumoperitoneum on Cardiac Performance.

Start date: May 1, 2024
Phase:
Study type: Observational

The field of robotic-assisted laparoscopic surgery increases all the time. Older and more fragile patients which are not suitable for major open surgery could be scheduled for robotic- assisted surgery. The peroperative anesthesiological challenges and stresses during this type of surgery could anyway be even more prominent. The extreme positioning of patients during robotic surgery in the pelvis, often 30 degrees head down tilting (Trendelenburg positioning), should increase the work load of the heart significantly. There are no studies concerning fragile patients with heart failure during these conditions. In this study the circulatory effects in patients with normal heart function and preexisting heart failure will be studied during robotic surgery in extreme Trendelenburg positioning During surgery the work load and performance of the heart will be monitored using an esophageal doppler and optical spectrophotometry measuring regional saturation of the brain. This study can identify patients at risk of developing critical circulatory failure during this type of surgery.

NCT ID: NCT06332391 Not yet recruiting - Clinical trials for Heart Failure, Systolic

Paced Heart Rate Acceleration for Cardiac Conditioning

HeartExcel
Start date: May 20, 2024
Phase: N/A
Study type: Interventional

A clinical trial of exercise-similar heart rate acceleration delivered via cardiac pacing vs. sham intervention in subjects at rest will be performed. The study population comprises subjects with guideline-directed medically managed severe left ventricular dysfunction due to ischemic or non-ischemic cardiomyopathy and an existing implantable cardioverter defibrillator or biventricular implantable cardioverter defibrillator. The purpose of the study is to understand how the heart rate pattern of exercise contributes to the considerable cardiac conditioning effects of exercise and estimate whether the pacing approach may have translational clinical applicability. Fifty-two subjects will be randomized, single-blinded, to either the pacing intervention or a sham intervention which they will receive once daily, 3 days/week for 6 weeks. Baseline symptoms and clinical test results will be compared to the same measures at 2 weeks, 4 weeks and 6 weeks of intervention/sham and at 3 months and one-year post-intervention. The primary endpoint will be the change in left ventricular ejection fraction from baseline in intervention vs. sham groups (mixed effects linear regression with time and treatment arm as fixed effects and pre-specified covariates of sex and cardiomyopathy type as random effects). Secondary endpoints will include changes in quality of life, 6-minute walk distance, cardiopulmonary exercise test (CPET) measures, daily activity and major adverse cardiac events (MACE) at 3 and 12 months between pacing and sham groups. A "dose-response" analysis of outcomes at 2, 4, and 6 weeks of the intervention vs. sham compared with baseline will be performed.

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: NCT06240403 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Digoxin and Senolysis in Heart Failure and Diabetes Mellitus

Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

In pilot studies the investigators have shown that subcutaneous adipose tissue (SAT) from patients with reduced ejection fraction heart failure (HFrEF) and type 2 diabetes mellitus (T2DM) is dysfunctional. Endothelial cells from the adipose tissue from these patients are senescent and have deleterious effects on healthy human subcutaneous adipocytes, including increasing expression of IL-6 (gene and protein) and reducing glucose uptake. Digoxin, a well-established treatment for HFrEF, selectively clears these senescent endothelial cells and prevents adipocyte dysfunction. This study will examine the effect of digoxin on adipose tissue on the burden of senescent cells.

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: NCT06084468 Active, not recruiting - Stroke Clinical Trials

Cardiac Structure and Function in Patients With Cystic Fibrosis

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

In a prospective observational cohort study (n = 100), the investigators aim to assess the correlation between cardiac biomarkers, advanced echocardiography and cystic fibrosis genotype and severity and determine whether these are prognostic markers of heart disease in patients suffering from cystic fibrosis (CF).

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).