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Heart Failure, Diastolic clinical trials

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NCT ID: NCT04475042 Recruiting - Clinical trials for Heart Failure, Diastolic

Stratified Treatment to Ameliorate Diastolic Left Ventricular Stiffness in Heart Failure With Preserved Ejection Fraction

STADIA-HFpEF
Start date: July 1, 2020
Phase: Phase 2
Study type: Interventional

A 35-week, single-center, prospective, double-blind, controlled, randomized, 2x2 crossover, interventional Phase II study, investigating the effect of treatment with dapagliflozin 10mg od on Left Ventricular distensibility in patients with early HFpEF.

NCT ID: NCT04450576 Active, not recruiting - Clinical trials for Heart Failure, Diastolic

HbA1c as an Early Serologic Marker for the Hemodynamic Progression of Stage A Heart Failure

Start date: December 20, 2019
Phase:
Study type: Observational

In a retrospective community based cohort study from Pueblo County Colorado which has a higher population proportion of metabolic syndrome and diabetes mellitus, we hope to clarify and quantify an association of the AGE HBa1c elevation with the early subclinical hemodynamic changes of diabetic cardiomyopathy as measured by LAV, LVM, E/A ratio, E/e' ratio and BNP in patients with stage A heart failure.

NCT ID: NCT04336995 Completed - Clinical trials for Heart Failure, Diastolic

Exercise Pulmonary Transit Time

Start date: August 27, 2020
Phase: Phase 4
Study type: Interventional

The study seeks to measure pulmonary transit time via contrast-echocardiography before and after exercise.

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: NCT04179643 Recruiting - Heart Failure Clinical Trials

NAN-101 in Patients With Class III Heart Failure

NAN-CS101
Start date: November 20, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of BNP116.sc-CMV.I1c in patients with NYHA Class III heart failure. Patients with symptomatic congestive heart failure will be enrolled until up to 12 subjects have received infusions of investigational product. All patients will be followed until 12 months post treatment intervention, and then undergo long-term follow-up via semi-structured telephone questionnaires every 6 months for an additional 24 months (+/- 30 days).

NCT ID: NCT04160000 Recruiting - Heart Failure Clinical Trials

Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure

TAP-CHF
Start date: July 26, 2020
Phase: Phase 4
Study type: Interventional

Heart failure (HF) with preserved left ventricular function (pEF) is difficult clinical syndrome to treat effectively with few evidence based therapies. Atrial fibrillation (AF) is now an important co-morbidity being observed in 43% of patients with HFpEF. Rhythm control has not been studied in this population. Catheter ablation and antiarrhythmic drugs are rhythm control therapies that have been used for treatment of AF without HF or HF with reduced systolic function but have not been widely applied in HFpEF. No controlled comparative evaluation has been performed in HFpEF. The introduction of wireless pulmonary artery hemodynamic monitoring has permitted optimization of HF therapy in patients with chronic HF with reduced and preserved EF. Reduction in HF hospitalizations has been observed in post hoc analyses of HFpEF patients but has not been systematically applied in AF patients with HFpEF. In this study, we propose to study both rhythm control and optimized HF therapeutic approaches in an AF with HFpEF study population in a pilot study using a sequential two phase randomized controlled clinical trial design.

NCT ID: NCT04157660 Completed - Clinical trials for Heart Failure, Diastolic (HFpEF)

Effect of Short-term Oxygen During CPET in HFpEF

Start date: September 12, 2019
Phase: N/A
Study type: Interventional

In a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with heart failure with preserved ejection fraction.

NCT ID: NCT04154878 Completed - Clinical trials for Diastolic Heart Failure

2 New Measurements Used to Describe the Filling Phase of the Left Ventricle (LV).

INDEX
Start date: October 30, 2019
Phase:
Study type: Observational

As we live longer our population experiencing heart failure (HF) continues to grow consuming an increasing percent of healthcare dollars. Systolic heart failure or pump failure is easy to recognize and measure and is expressed as ejection fraction. Diastolic heart failure (DHF) or failure to fill adequately is much more difficult to quantify with no single measure or number being used to express the severity instead groupings are used with normal and Grade I, II or Grade III to classify with Grade III being the direst. Heart Failure with Reduced Ejection Fraction (HFrEF) and Heart Failure with Preserved Ejection Fraction (HFpEF) are used to identify the primary clinical presentation of HF but do not adequately describe the combined effect often presenting within the same subject. It is estimated 35 to 50% of those with HFrEF, having Left Ventricle Ejection Fraction (LVEF) < 50%, and 50 to 70% of those with HFpEF, having ejection fraction ≥ 50%, also have moderate to severe diastolic dysfunction (DD). The purpose of this study is two fold. The first is to determine if the rate of change measured from the left ventricular inflow inspiratory phase Doppler waveform provides insight into a cause of diastolic heart failure by comparing echocardiographic data points obtained prior to and immediately following optimization of a bi-ventricular pacemaker. This HF population requires an ejection fraction of 35 percent or lower to qualify for the device. These echocardiograms have been previously completed and will be reanalyzed. The second purpose is to determine if relationships between different features of a LV volume curve can be used to generate a single number to describe global diastolic function using the same echocardiograms from the pacemaker group. Results will be compared to a small group of healthy normal participants as a control for validation.

NCT ID: NCT04154657 Recruiting - Clinical trials for Heart Failure, Diastolic

Mechanisms of Right Ventricular Adaptation in Patients With Heart Failure With Preserved Ejection Fraction

INTERACT-HFpEF
Start date: February 15, 2020
Phase: N/A
Study type: Interventional

Biventricular PV-loop studies and advanced imaging to assess left-to-right ventricular interaction in HFpEF: In a group of 30 HFpEF patients with clinical indication for LH/RH catheter investigation, we will perform biventricular PV loop assessment in combination with extensive imaging (MRI, echo) for in-depth analysis of left-to-right ventricular interaction in the different HFpEF categories, both under baseline and stress (volume challenge and exercise) conditions.

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