Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Raising pacemaker heart rate during light exercise to lower left-heart pressures in HFpEF

Official title: The Impact of Accelerated Pacing and AV-delay Regulation on the Pulmonary Capillary Wedge Pressure During Exercise in Patients With HFpEF

Run by Universitaire Ziekenhuizen KU Leuven · NCT07270536 · Data updated 2026-11-12

This test will try whether temporarily increasing the heart rate by adjusting pacemaker settings during light exercise can lower left-heart filling pressures and improve cardiac output in people with HFpEF who already have a DDD pacemaker.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorUniversitaire Ziekenhuizen KU Leuven
Academic / other
Locations2 sites (Hasselt and 1 other locations)
StatusRecruiting
StartedDecember 10, 2025
Main results expectedMarch 1, 2027
Study endsMarch 1, 2027
Registry record updatedJune 5, 2026
Trial IDNCT07270536 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with HFpEF in sinus rhythm who have had a DDD pacemaker with left bundle branch area pacing implanted at least 12 weeks prior and are on optimized HFpEF therapy.

Probably not a fit

Patients without a compatible pacemaker, with atrial arrhythmias, significant pulmonary comorbidity, or who cannot undergo invasive catheter testing are unlikely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with HFpEF who have a DDD pacemaker will undergo a single on-site invasive hemodynamic test while pedaling a light stationary bike. A venous and arterial catheter will measure intracardiac pressures and blood oxygen while the pacemaker heart rate is increased in three steps and the AV delay is optimized. Measurements at each step will be used to identify the heart rate associated with the lowest filling pressures and to calculate cardiac output. The visit lasts about three hours and the protocol plans to enroll 20 patients from Leuven and Hasselt.

Why it matters

Potential benefit: If successful, this approach could provide a non-drug way to reduce exercise-related left-heart pressures and potentially improve exercise capacity by reprogramming an existing pacemaker.

How similar studies have gone: Small physiologic studies and case reports suggest heart-rate modulation can lower filling pressures, but using pacemaker-driven accelerated pacing in HFpEF remains largely experimental.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Jessa Ziekenhuis Hasselt
    Hasselt, Belgium
    Recruiting
  • University Hospitals Leuven
    Leuven, Belgium
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.