Leg workouts may unlock a hidden cause of exercise intolerance in common heart failure

NCT ID NCT03465072

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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.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
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)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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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

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First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This study investigates whether a specific leg exercise program can improve how blood vessels, muscles, and nerves work during exercise in people over 65 with heart failure with preserved ejection fraction (HFpEF). The trial focuses on peripheral problems—like reduced blood flow and slow oxygen uptake—rather than the heart itself. Participants will undergo 8 weeks of supervised knee extensor training to see if it boosts exercise tolerance and daily function.

What this could mean

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

Active substance
a supervised exercise training program targeting the leg muscles
What this could lead to
If it works, this could point toward a simple, drug-free way to improve exercise capacity and quality of life in people with this type of heart failure.
What could go wrong
This is a small, early-stage study with only 22 participants. The exercise program is supervised and may not be feasible for all patients. Results may not apply to the broader heart failure population.

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

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2018

Expected to finish

Mar 2027

An estimate. End dates often move.

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

65 to 85 years

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.

All subjects will be \>65 years of age. The controls will be screened carefully for hypertension and cardiac disease, including structural heart and hemodynamically significant obstructive coronary disease, using a history, physical examination, and resting and post-exercise transthoracic echocardiograms. Additional exclusion criteria for this group will include valvular heart disease, atrial flutter/ fibrillation, renal insufficiency, chronic lung disease, regular cigarette smoking within the past 10 years, and cardiovascular medication. Subjects demonstrating greater than moderate levels of activity \> 2 days per week will not be allowed to participate, as chronic high levels of physical activity could potentially impact the primary outcome variables. * HFpEF Inclusion Criteria: * Patients will be \> 65 years old * We will use a modification of the European Guidelines for the diagnosis of HFpEF to select the patient population. * The key components of these guidelines include: * signs and symptoms of heart failure; * b) an ejection fraction \> 0.50; and * c) objective evidence of diastolic dysfunction. To satisfy the first criteria, we will use the Framingham criteria (dyspnea, orthopnea, PND, edema); however we will require objective evidence of congestion including * chest X-ray, * elevated BNP, * or elevated PCWP (pulmonary capillary wedge pressure) or * LVEDP (left ventricular end-diastolic pressure) \> 16 mmHg; for the second, we will accept echo, nuclear or catheter documentation; and for * we will require a depressed tissue Doppler mitral annular velocity \< 7.5 cm/s along with PCWP \> 16 mmHg if available. HFpEF Exclusion Criteria: * underlying valvular or congenital heart disease; * restrictive or infiltrative cardiomyopathy; * acute myocarditis; * NYHA Class IV CHF, or CHF that cannot be stabilized on medical therapy; * other condition that would limit the patient's ability to complete the protocol; * manifest ischemic heart disease. * Patients with CABG or previous history of atrial fibrillation will be allowed to participate, though for safety reasons, patients on Coumadin will be excluded. * All patients must be in sinus rhythm without a left bundle branch block at the time of study, and be off beta blockers or non-dihydropyridine Ca++ blockers for at least 5 half-lives. β blockers will be weaned over 3-5 days and additional doses of vasodilators added to control blood pressure if necessary. Drugs that affect the renin-angiotensin-aldosterone system and diuretics will be maintained.

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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.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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Contacts and locations

Locations

  • The Institute for Exercise and Environmental Medicine

    Dallas, Texas, 75231, United States

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