CompletedPhase 1/2

External Body Pressure in Heart Failure With Preserved Ejection Fraction

United States27 participantsStarted 2023-04-21

Plain-language summary

The primary objective of the study is to test the impact of positive and negative body pressure on exercise capacity, symptoms, blood volume distribution and central cardiac hemodynamics in patients with heart failure and preserved ejection fraction. Aim 1 will study healthy volunteers and heart failure patients non invasively while Aim 2 will study heart failure patients invasively (intracardiac pressures).

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* Heart Failure Study Population * Inclusion Criteria (Aim 1 and 2): * Age greater than or equal to 30 yrs * Established diagnosis of HFpEF with left ventricular ejection fraction greater than or equal to 50% * NYHA II-III symptoms * Stable HF drug regimen for the preceding 1 month * Wedge pressure greater than or equal to 15 mmHg at rest or greater than or equal to 25 mmHg with peak exercise * (For Aim 2 only) Scheduled for an elective right heart catheterization at Duke University Hospital. * Exclusion Criteria (Aim 1 and 2): * HF hospitalization for type I myocardial infarction within 3 months * Infiltrative (ie amyloid) or hypertrophic cardiomyopathy * Uncontrolled atrial or ventricular arrhythmia * Chronic oxygen use * History of vasovagal syncope * Considered inappropriate to participate by PI or Sub-I * Healthy Volunteers (Controls) * Inclusion Criteria (Aim 1): * Age greater than or equal to 30 yrs * Able to speak English * Ambulatory \[assistive devices ok\] * Able to provide informed consent * Exclusion Criteria (Aim 1): * Acute myocardial infarction (3-5 days) * Unstable angina * Uncontrolled arrhythmia causing symptoms or haemodynamic compromise * Syncope * Active endocarditis * Acute myocarditis or pericarditis * Symptomatic severe aortic aneurysm * Uncontrolled asthma * Arterial desaturation at rest on room air \<85% * Untreated left main stem coronary stenosis * Asymptomatic severe aortic stenosis * …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

change in exercise cardiac output

Timeframe: Day 1

Trial details

NCT IDNCT05764564

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More Heart Failure, Diastolic trials