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Pacemaker trick may boost failing right heart in lung disease

NCT ID NCT04194632

Disease control Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

In pulmonary arterial hypertension, the right side of the heart works against high pressure in the lungs and can weaken over time. This study tests whether temporary pacing of the right ventricle at the spot where it contracts latest can improve its pumping strength. Researchers will measure changes in contractility and blood output during a routine heart catheterization in 16 patients with this condition. The goal is to see if this pacing approach could become a new way to support the failing right heart.

What this could mean

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

Active substance
Temporary right ventricular pacing, a procedure where a pacemaker stimulates the heart's right ventricle at the site of latest activation to improve its pumping efficiency.
What this could lead to
If pacing improves right ventricular contractility and blood flow, it could become a new treatment option for heart failure in pulmonary arterial hypertension, where current therapies do not directly target the heart's pumping strength.
What could go wrong
This is a small, early-phase study in 16 patients, so results may not apply broadly. Pacing might not improve heart function, or the benefit could come at the cost of increased oxygen demand or wall stress on the heart.

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 16 people

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

Started

Jan 2021

Expected to finish

Jan 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

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Inclusion Criteria: * Patients referred for a clinically indicated right heart catheterization to either diagnose pulmonary arterial hypertension prior to initiating therapies or monitor response to ongoing therapies in patients with diagnosed pulmonary arterial hypertension. * Patients with pulmonary arterial hypertension with or without significant right ventricular dysfunction as assessed by baseline echocardiography and standard of care right heart catheterization * Functional class 2 or 3 symptoms * Are able to undergo cardiac MRI, endocardial mapping, and pressure volume measurements * English speaking * All patients will be required to have evidence of right ventricular hypertrophy or conduction delay (QRS \> 130ms) on surface ECG Exclusion Criteria: * Preexisting left bundle branch block, current atrial fibrillation, or pacemaker/ defibrillators * Functional class 4 symptoms * Patients treated with parenteral or subcutaneous therapies for pulmonary hypertension * Contraindication to right heart catheterization including significant thrombocytopenia (platelets \< 50,000), coagulopathy (INR \> 1.8), or pregnancy as determined by routine screening laboratory work * Mean pulmonary artery pressure less than 25 mmHg as determined by the right heart catheterization on the day of the study procedure * Pulmonary capillary wedge pressure greater than or equal to 15 mmHg as determined by the right heart catheterization on the day of the study procedure * Severe tricuspid regurgitation as determined by baseline transthoracic echocardiogram. * Left ventricular dysfunction (EF \< 50%) as determined by baseline transthoracic echocardiogram. * Inability to complete cardiac MRI or transthoracic echocardiography * Patients with confounding systemic disease specifically portopulmonary hypertension and scleroderma associated pulmonary hypertension * Patients otherwise deemed not appropriate for the study as determined by the study investigators

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Conditions

The condition(s) this trial relates to.

Familial Primary Pulmonary Hypertension pulmonary arterial hypertension pulmonary hypertension Ventricular Dysfunction, Right

As listed by the trial registrant

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

Pulmonary artery hypertension Right ventricular dysfunction

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

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