Pacemaker tweak may help heart failure patients breathe easier during exercise
NCT ID NCT07270536
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
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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
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Jessa Ziekenhuis Hasselt
RECRUITINGHasselt, 3500, Belgium
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University Hospitals Leuven
RECRUITINGLeuven, 3000, Belgium
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