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Pacemaker tweak may help heart failure patients breathe easier during exercise

NCT ID NCT07270536

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether increasing the pacemaker rate during light exercise can lower pressure inside the heart for people with heart failure with preserved ejection fraction (HFpEF). Twenty participants will have their heart pressures measured at rest and while cycling, as the pacemaker rate is gradually increased. If successful, this could lead to a simple, drug-free way to reduce breathlessness and fatigue.

What this could mean

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

Active substance
accelerated pacing with AV-delay optimization
What this could lead to
If it works, this could offer a simple, drug-free way to improve daily functioning and comfort for HFpEF patients with pacemakers.
What could go wrong
This is a very small, early study (20 participants) measuring immediate effects only. It may not translate to long-term benefits or apply to all HFpEF 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

About 20 people

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

Started

Dec 2025

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

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.

Participants eligible for inclusion in this study must meet all of the following criteria: 1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures 2. At least 18 years of age at the time of signing the Informed Consent Form (ICF) 3. Heart failure with preserved ejection fraction, defined as one of the below criteria: 1. EF \>= 45% and HFA-PEFF score \>= 5 (Heart Failure Association-Pre-test assessment, Echocardiography and natriuretic peptide, Functional testing, Final etiology; heart failure association of the European Society of Cardiology and the Heart Failure Association (34)) 2. EF \>= 45% and H2FPEF score \>= 6 (Heavy, Hypertensive, Atrial fibrillation, Pulmonary hypertension, Elder, Filling pressure; Mayo Clinic group (35))) 3. EF \>= 45% and i. History of heart failure hospitalization after pacemaker implantation or ii.On loop-diuretics at time of inclusion 4. Having a DDD-pacemaker with LBB area pacing, implanted at least 12 weeks before iCPET 5. \>=6 weeks on optimal HFpEF therapy (MRA and SGLT2i) at time of iCPET, unless contraindicated or not tolerated 6. Sinus rhythm at time of screening and iCPET Participants eligible for this Study must not meet any of the following criteria: 1. Participant has a history of: 1. Evidence of significant pulmonary comorbidity based on abnormal pulmonary function tests (FEV1 \<60%) or aberrant lung parenchyma more than mild on radiological imaging 2. Severe/symptomatic valvular diseases 3. Severe pulmonary hypertension (PASP \> 55mmHg estimated by Doppler Echo) 4. Unstable arrhythmias (VT, VF) 5. Recurrent syncopes after pacemaker implantation 6. Permanent atrial fibrillation 7. Amyloid cardiomyopathy 2. Physical inability to perform exercise 3. More than 1 hospitalization for heart failure in the last year 4. Resting heart rate\> 100bpm 5. At time of iCPET or inclusion: decompensated heart failure, unstable coronary syndrome 6. Contraindication to central venous access 1. Severe coagulopathy (e.g., spontaneous INR \> 2, thrombocytopenia \< 50,000/µL) 2. Local infection or skin infection at the insertion site 3. Thrombosis or anatomical abnormalities of the right jugular vein 4. Pneumothorax or contralateral lung pathology 5. Inability to properly position the patient 7. Contraindication to arterial access 1. Thrombosis or occlusion of the target artery 2. Raynaud's phenomenon or other vasospastic disorders 3. Active infection at the intended insertion site 4. Severe coagulopathy (e.g., spontaneous INR \> 2, thrombocytopenia \< 50,000/µL) 5. Insufficient collateral circulation (e.g., inadequate perfusion in an Allen test) 8. Contraindications to CPET 1. ECG signifying myocardial injury 2. ECG signifying current or potentially lethal arrhythmias 3. Systemic hypotension (e.g. systolic blood pressure \< 90 mmHg) 4. Extreme hypertension (e.g. systolic blood pressure \> 220 mmHg) 5. Syncope, presyncope, or lightheadedness 6. SaO2 \< 88% 7. Severely elevated PCWP (\> 40 mmHg) during exercise

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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

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

  1. The places running it

    2 sites. 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

  • Jessa Ziekenhuis Hasselt

    RECRUITING

    Hasselt, 3500, Belgium

  • University Hospitals Leuven

    RECRUITING

    Leuven, 3000, Belgium

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