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Pacemaker study aims to boost stamina in stubborn heart failure

NCT ID NCT06992089

Symptom relief Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a pacemaker can improve exercise ability and quality of life in people with heart failure with preserved ejection fraction (HFpEF) who also have a small heart chamber and a low heart rate during activity. About 30 participants will get a pacemaker and be randomly assigned to have it turned on or off for 3 months, then switch. The main goal is to see if pacing increases peak oxygen uptake, a measure of fitness.

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 30 people

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

Started

Jun 2025

Expected to finish

Jun 2026

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 years and older

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: * Stable symptomatic heart failure (NYHA functional class ≥II) during the last month. * Diagnosis criteria of HFpEF according to ESC guidelines: 1. symptoms and signs of HF. 2. left ventricular ejection fraction ≥50% by Simpson method. 3. proBNP \>125 pg/mL in the last month. 4. at least one additional criterion: 1. relevant structural heart disease (left ventricular hypertrophy and/or left atrial enlargement); and/or 2. Diastolic dysfunction. * Left ventricular hypertrophy was defined as wall thickness \> 10 mm. * Small ventricular volume was defined as indexed left ventricular end diastolic volume \< 45 ml/m2. * Adults ≥18 years old. * Previous admission for acute heart failure. * Chronotropic incompetence assessed by CPET, defined as: \[(HRmax - HRrest)\]/\[(220 - age) - (HRrest)\] \< 0.62. * Resting heart rate \< 65 bpm in sinus rhythm or 70 bmp in atrial fibrillation. Exclusion Criteria: * Inability to perform a valid baseline exercise test. * Significant primary pulmonary disease; including pulmonary arterial hypertension, chronic thromboembolic pulmonary disease or chronic obstructive pulmonary disease. * Patient with prior history of left ventricular ejection fraction \<50%. * History of an acute coronary syndrome in the previous 12 months. * Effort angina or signs of ischemia during CPET. * RER threshold at \<1.05 at the CPET. * Significant primary moderate to severe valvular disease. * Any other comorbidity with a life expectancy lower than 1 year. * Heart rate at rest \> 75 lpm. * Other pacemaker indication. * Pregnant women. * Baseline rhythm different from sinus rhythm or atrial fibrillation. * Active treatment with beta-blockers, digitalis or non dihidropiridine calcium channel blockers.

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Conditions

The condition(s) this trial relates to.

diastolic heart failure

As listed by the trial registrant

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

Heart failure with preserved ejection fraction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

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Contacts and locations

Locations

  • Hospital Clínico de la Comunidad Valenciana

    RECRUITING

    Valencia, 46010, Spain

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