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Heart Failure, Systolic clinical trials

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NCT ID: NCT04281849 Completed - Heart Failure Clinical Trials

Balance, Aerobic Capacity, Mobility and Strength in Patients Hospitalized for Heart Failure (BAMS-HF) Program

BAMS-HF
Start date: June 15, 2020
Phase: N/A
Study type: Interventional

This is a pilot randomized trial of the BAMS-HF (Balance, Aerobic capacity, Mobility and Strength in patients hospitalized for Heart Failure) Program versus usual care. The BAMS-HF Program pilot study is an initial step in eventually creating a comprehensive, patient-centered, primarily home-based rehabilitation intervention aimed at preventing worsening disability and dependence among older adults hospitalized for HF. The BAMS-HF Program will enroll patients hospitalized for HF (or with HF as an active problem during hospitalization) within the past 4 weeks and will engage patients during the vulnerable post-discharged period. The objective of this pilot study is to test the feasibility, acceptability and preliminary effect of the BAMS-HF Program in older (>/= 65 years) adults hospitalized for HF. The BAMS-HF Program will begin within 4 week of hospital discharge and be administered 3 times weekly for 12 weeks in the patient's home upon discharge. Patients who are able to safely complete the program without in-person assistance will transition to telehealth (aka telerehabilitation) visits. The BAMS-HF Program is innovative because it is home-based, and will utilize rigorous, progressive exercises across multiple domains of physical function. The estimated preliminary effect size will be measured with the Short Physical Performance Battery (SPPB), a well-validated measure that predicts incident mobility/disability and falls in the geriatric population. Aim #1: To assess the feasibility of the BAMS-HF Program by measuring 1) study enrollment rate, 2) proportion of prescribed sessions that were actually performed, 3) proportion of patients completing full baseline assessment and outcome measures Aim #2: To assess the acceptability of the BAMS-HF Program with qualitative interviews of participants in the intervention arm that will ask about their experience in the program, any aspects of the intervention they recommend changing and whether patients would recommend the program to others. Reason for declining or stopping participation in the study will also be recorded and considered in adjusting the study protocol. Aim #3: To estimate the preliminary intervention effect by investigating the difference in change in SPPB between the BAMS-HF Program arm and the usual care arm.

NCT ID: NCT04145635 Completed - Heart Failure Clinical Trials

The Aortix CRS Pilot Study

Start date: February 5, 2021
Phase: N/A
Study type: Interventional

The Aortix CRS Pilot Study: An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients with Cardiorenal Syndrome

NCT ID: NCT04112576 Completed - Clinical trials for Heart Failure, Systolic

Physiological Signals, Activity and Posture for Surface Mounted Insertable Cardiac Monitor in Heart Failure Study

HAPI-HF
Start date: July 23, 2020
Phase:
Study type: Observational

To characterize the physiological signals collected from a Wearable Cardiac Monitor (WCM) prototype device in subjects with heart failure and preserved ejection fraction (HFpEF) and compare against signals from subjects with heart failure and reduced ejection fraction (HFrEF). To evaluate the relationship of physiological signals measured from a wearable cardiac monitor (WCM) prototype device with ECHO measures of systolic and diastolic function

NCT ID: NCT04065893 Completed - Clinical trials for Ventricular Tachycardia

Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy

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

Cardiac resynchronization therapy reduces mortality in patients with systolic heart failure and left bundle branch block. Reduced biventricular pacing can lead to therapy failure. Most effective mortality reduction was seen with a BiV pacing above 98%. Reduced BiV pacing is a common phenomenon with potential impact on CRT-response and pts' prognosis. Frequent ventricular ectopy may be associated with attenuated benefit from CRT. The investigators sought to systematically assess the effect of ventricular arrhythmia treatment on BiV pacing.

NCT ID: NCT04064541 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction

Virtual Visits to Optimize Research Trial Offerings to HF Patients

Optimize-HF
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

This pilot study seeks to understand if distance health technology with virtual visits hold the key to improving access for patients who wish to partake in clinical trials clearing barriers to enrollment.

NCT ID: NCT04019314 Completed - Heart Failure Clinical Trials

Assessment of ProEnkephalin to Detect Acute Kidney Injury (AKI)

Start date: June 11, 2019
Phase: N/A
Study type: Interventional

Researchers are observing the values of proEnkephalin (PENK) via a blood draw in hospitalized patients that are volume overloaded requiring diuresis. If changes in PENK are found, physicians may predict values of change in kidney function during treatment.

NCT ID: NCT03917459 Completed - Heart Failure Clinical Trials

COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure

CONFIDENCE-HF
Start date: April 16, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine the effect of sacubitril/valsartan (LCZ696) vs. Enalapril on improvement in erectile function and ability in male patients with chronic heart failure with reduced ejection fraction and erectile dysfunction.

NCT ID: NCT03677271 Completed - Clinical trials for Heart Failure, Systolic

A Novel Home-based Physical Activity Intervention for Stable Chronic Heart Failure Patients

PAHF
Start date: December 16, 2015
Phase: N/A
Study type: Interventional

The project focuses on heart failure (HF), a complex clinical syndrome of symptoms and signs that suggest the efficiency of the heart as a pump is impaired. Around 950,000 people in the UK have HF. Both the incidence and prevalence of heart failure increase steeply as a result of an ageing population, improved survival of people with ischaemic heart disease and more effective treatments for heart failure. Aside from the obvious individual burden HF also accounts for 1 million inpatient bed days - 2% of all NHS inpatient bed days and 5% of all emergency medical admissions to hospital which are projected to rise by 50% over the next 25 years. There is a pressing need to explore effective ways to manage the individual and societal burden of HF. Despite exercise being an effective, safe, and a recommended (class I) therapy for people with heart failure according to clinical guidelines from the UK, EU, and USA, it is currently out of reach for majority people with HF. This project addresses this directly by designing and evaluating an exercise therapy that will be available to those living with HF with potential to improve their symptoms, function and quality of life

NCT ID: NCT03627585 Completed - Clinical trials for Heart Failure, Systolic

Reprogramming to Prevent Progressive Pacemaker-induced Remodelling

PPPR
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

The aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity. This will be achieved by showing in a single centre, phase II, double-blind, randomised, placebo-controlled trial that reducing the amount of pacemaker beats to a minimum reverses these changes and extends battery life.

NCT ID: NCT03534297 Completed - Clinical trials for Systolic Heart Failure

Study of Dapansutrile Capsules in Heart Failure

Start date: May 16, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1b randomized, double-blinded, single-center safety and pharmacodynamics study of sequential cohort, dose-escalating, repeat-dosing of dapansutrile or placebo (4:1 ratio) in subjects with stable systolic heart failure (HF) with LVEF≤40% symptomatic for NYHA functional classification II-III who show signs of systemic inflammation (high sensitivity plasma C reactive protein [hsCRP] > 2 mg/L). A total of 30 subjects will be enrolled in 3 sequential cohorts by randomized allocation (8 active and 2 placebo within each cohort). Progression to cohort 2 with dose escalation will occur following the Day 28 visit of the last subject in the first cohort. Progression to cohort 3 with dose escalation will occur following the Day 8 visit of the last subject in the second cohort. Subjects will be screened and evaluated twice for eligibility: 1) at the time of Screening (up to 28 days prior to enrollment); and 2) at the Baseline visit, prior to randomization. Following enrollment, Baseline assessments will be conducted and the first dose of investigational product (either dapansutrile capsules or placebo capsules) will be administered at the clinical site upon completion of all assessment and collection of baseline parameters. Subjects will then self-administer investigational product once, twice or four times daily, depending on cohort, for up to fourteen (14) consecutive days beginning at the Baseline visit and continuing through the planned Day 14 visit. Subjects will return to the study clinic on Days 4, 8, 14 and 28 for follow-up visits. Additionally, subjects will be contacted for telephone follow-up on Day 42.