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Heart Failure clinical trials

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NCT ID: NCT05572814 Recruiting - Heart Failure Clinical Trials

Transform: Teaching, Technology, and Teams

T3
Start date: September 30, 2022
Phase: N/A
Study type: Interventional

This initiative supports a quality improvement effort evaluating the use of strategies (including technology-based decision support, referral to a virtual GDMT team, and general educational tools/resources for clinicians and patients) to improve use of guideline-directed therapeutics known to lower cardiovascular (CV) events among patients with cardiovascular diseases of heart failure, atrial fibrillation and type 2 diabetes (T2D)/ASCVD with a specific focus on underserved populations and those with a history of health care disparities.

NCT ID: NCT05568069 Recruiting - Heart Failure Clinical Trials

RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure

BRITISH
Start date: April 12, 2023
Phase: N/A
Study type: Interventional

BRITISH is a UK multicentre trial of patients who have been diagnosed with heart failure due to Non-Ischemic Cardiomyopathy (NICM, or heart failure that is not caused by blocked heart arteries. Participants will be randomised into two groups. Half the participants will receive an Implantable Cardioverter-Defibrillator (ICD) and the other half will not. The aim of the study will be to compare all-cause mortality (death from any cause) between these two groups at 36 months, and longer-term to 10 years. The study has the potential to change international heart failure treatment guidelines and to improve how patients with this condition are managed.

NCT ID: NCT05566600 Recruiting - Clinical trials for Chronic Heart Failure

Allogeneic iPSC-derived Cardiomyocyte Therapy in Patients With Worsening Ischemic Heart Failure

Start date: October 9, 2022
Phase: Early Phase 1
Study type: Interventional

This study is designed to evaluate the safety and efficacy of allogeneic induced pluripotent cell derived cardiomyocytes (iPSC-CMs) in treating patients with worsening ischemic heart failure undergoing coronary artery bypass graft surgery. After screening, iPSC-CMs will be administrated intramyocardially in consented and eligible patients undergoing open-chest CABG surgery and the estimated population size for the study will be 32 patients.

NCT ID: NCT05564793 Recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Improving CRT Outcome With Non-Invasive Cardiac Mapping

ICONIC-M
Start date: December 20, 2023
Phase: N/A
Study type: Interventional

The ICONIC-M study is a multicenter randomized controlled study to assess patient response to CRT comparing ECGI map guided left ventricular lead placement with empirical lead placement. The hypothesis of the investigation is to demonstrate that CRT LV lead implantation guided by a map obtained with the Amycard 01C System and showing LV Latest Electrical Activated Site (LEAS) in combination with a CT cardiac venogram improves CRT outcome. An improved CRT outcome is defined as a ≥30% increase in LVESVi reduction compared to empiric CRT LV lead implantation. The sample size will be 136 in the Control arm and 194 in the Active arm. A total of 330 subjects. The study follows an adaptive design, in where one interim analysis at 70% enrollment will be performed. The sponsor may stop enrollment when either one of the following conditions apply: - Statistical significant difference between groups in the primary endpoint has been reached confirming a difference in reduction of the LVESVi of ≥30% in the Active arm compared to the Control arm - There is no trend or reason to believe statistical significance will be reached with a higher sample size. Statistical significance (primary endpoint) is reached at interim (70%) or at total (100%) of enrollment with a significance value P lower than 0.025.

NCT ID: NCT05564689 Recruiting - Heart Failure Clinical Trials

Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy

FLOW-LBBB
Start date: September 29, 2022
Phase:
Study type: Observational

Cardiac resynchronization therapy (CRT) is an effective therapeutic strategy in patients with symptomatic heart failure (HF) patients with LVEF of ≤35% and left bundle branch block (LBBB). However, approximately one-third of CRT-recipients do not improve after therapy (non-responders), despite meeting the required criteria. Previous studies have documented that the positive respons to CRT is related to the delayed electrical activation of the left ventricle in patients with LBBB. It has also been illustrated that non-ischemic CRT-candidates with LBBB demonstrate lower regional myocardial blood flow and metabolism in the septum. Additionally, it has been suggested that LBBB can lead to impaired coronary blood flow in the left anterior descending artery (LAD). This observation is based on an echocardiography-based study, that showed that the percentage of diastolic flow duration (%DD) in LAD was shorter in patients with LBBB compared to the control-group and patients with right-ventricular pacing. It has been demonstrated that CRT has positive effects on septal myocardial perfusion in patients with HF and LBBB. The dominant hypothesis explaining this phenomenon is built on improved septal myocardial work after CRT-implantation, which leads to increased myocardial energy and therefore increased myocardial perfusion. In contrast, it has been suggested that due to re-established synchronous left ventricular electrical activation, CRT reduces the septal intramyocardial pressure in early diastole, leading to a relatively longer antegrade flow duration in LAD. Therefore, the aim of the study is to evaluate the effect of CRT on coronary blood flow in LAD in patients with non-ischemic HF and LBBB. The investigators hypothesize that increased LV-function after CRT not only is due to resynchronized LV ejection and filling, but also improved coronary flow. The study aims to enroll 60 patients with heart failure due to non-ischemic dilated cardiomyopathy, LBBB, with or without CRT. All patients meeting the criteria will be recruited from the outpatient clinic at the Department of Cardiology, Aalborg University Hospital. Invasive flow measurements in the LAD, including fractional flow reserve (FFR), absolute coronary flow and -reserve will be conducted with the CRT on and off, respectively.

NCT ID: NCT05562167 Recruiting - Heart Failure Clinical Trials

The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF)

iNIX-HF
Start date: March 31, 2023
Phase: Phase 2
Study type: Interventional

The goals of this project are to determine the effectiveness of acute (2 hours after a single dose) and chronic (after 6 weeks of once-a-day dosing) KNO3 treatment (10mmol) vs. placebo on quadriceps muscle power and on aerobic exercise performance (V̇O2peak) in patients with HFrEF (left ventricular ejection fraction <45%). The investigators hypothesize that both acute and chronic dosing of 10mmol of KNO3 will improve exercise performance in HFrEF. To test this hypothesis, the investors will perform a randomized, double-blind, placebo-controlled, parallel-arm design study.

NCT ID: NCT05562063 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients

Start date: October 26, 2022
Phase: Phase 4
Study type: Interventional

The clinical benefits of the dual Sodium-Glucose cotransporter (SGLT) 1 and 2-inhibition have recently been reported in two clinical trials. The SOLOIST reported the benefits of sotagliflozin in Type-2 Diabetes Mellitus (T2DM) patients hospitalized for worsening of Heart Failure (HF), while the SCORED involved T2DM patients with Chronic Kidney Disease (CKD). It is worth noting that not only did the event curves separate within the first week post-treatment, but the effects of sotagliflozin on HF-related outcomes were observed regardless of Left Ventricular Ejection Fraction (LVEF) values and did not seem to attenuate with increasing LVEF as seen with empagliflozin and sacubitril/valsartan. Despite the favorable outcomes, the mechanism(s) of action through which sotagliflozin exerts these benefits remains unclear. The present study aims to investigate the potential (non-glucose dependent) "cardio-renal" pleiotropic effects of sotagliflozin in a mechanistic, randomized, double blind, placebo-control trial in HF patients with preserved ejection fraction (HFpEF). Comparisons between treatment groups will be made using cardiac MRI, CPET, 6-MWT and KCCQ-12.

NCT ID: NCT05562037 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA

Start date: September 8, 2022
Phase: N/A
Study type: Interventional

This feasibility trial will focus on older adults 60+ who are candidates for cardiac or pulmonary rehabilitation and who are vulnerable, mildly or moderately frail. We will randomize older frail adults living in rural regions of the county to Treatment as usual (TAU) or Stepped care (SC). TAU refers to center-based rehabilitation (CBR). Patients randomized to SC will be enrolled in traditional CBR and based on prespecified non-response criteria, will step up to three services: 1) Transportation-subsidized CBR, 2) Home-based telerehabilitation (TR), and 3) Community health worker-(CHW) supported home-based TR.

NCT ID: NCT05558605 Recruiting - Heart Failure Clinical Trials

Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment

AGILE-Echo
Start date: February 24, 2023
Phase: N/A
Study type: Interventional

Heart Failure and valvular heart disease are disproportionate problems in rural and remote Australia (RRA). Echocardiography is the best imaging investigation, and essential for management, but access to this essential test shows huge geographic variations, primarily because of dependence on expert acquisition. This trial seeks to demonstrate the effectiveness of artificial intelligence-based echocardiography for triage and management of patients with known or suspected heart disease in RRA.

NCT ID: NCT05556785 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Association of Epicardial Adipose Tissue Volume Axnd Radiodensity With Coronary Artery Calcification in Patients With HFpEF

Start date: January 1, 2020
Phase:
Study type: Observational

Recruiting patients who were diagnosed with HFpEF. Using Non-contrast CT to measure the total Agatston coronary artery calcification score, epicardial adipose tissue volume and attenuation. Analysing the correlation between them.