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Scientists squeeze and release heart failure patients to uncover exercise secrets

NCT ID NCT05764564

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study looked at how applying positive or negative pressure around the body affects exercise in people with heart failure with preserved ejection fraction. 27 participants, including healthy volunteers and heart failure patients, were tested non-invasively and some invasively. The goal was to measure changes in cardiac output, heart rate, and other factors during exercise.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors understand how body pressure changes affect exercise capacity in heart failure patients, potentially guiding future treatments.
What could go wrong
This is a small, early-phase study (27 participants) focused on understanding mechanisms, not testing a treatment. Results may not apply to all heart failure patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

27 people

The number who actually took part.

Started

Apr 2023

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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 * Severe untreated arterial hypertension at rest (\>200 mm Hg systolic, \>120 mm Hg diastolic) * Tachyarrhythmias or bradyarrhythmias * Hypertrophic cardiomyopathy * Significant pulmonary hypertension * Thrombosis of the lower extremity until treated for a minimum of 2 weeks * Within 2 weeks of acute symptomatic pulmonary embolus * Abdominal aortic aneurysm \>8.0 cm * Electrolyte abnormalities * Pregnancy * Inmate of correctional facility (i.e. prisoner) * Diagnosed history of dementia * Inability to ambulate independently * Considered inappropriate to participate by Principal Investigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

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