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RECRUITING

NCT07270536

Accelerated Pacing and Cardiac Filling Pressures During Exercise in Patients With Heart Failure With Preserved Ejection Fraction

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

Summary

Heart failure with preserved ejection fraction (HFpEF) is a condition where the heart pumps strongly enough, but has trouble relaxing and filling with blood properly. This causes the pressure on the left side of the heart to rise, especially during activity, which can lead to symptoms like shortness of breath and fatigue. Even light activities such as walking or climbing stairs can be difficult, limiting daily life. Recent research suggests that increasing the heart rate in people with HFpEF may help lower this elevated pressure in the heart. Because patients usually experience their symptoms during exercise, this study aims to see whether, during light activity, increasing the heart rate in patients who already have a pacemaker by adjusting its settings, can reduce this elevated pressure in the heart. Furthermore, we will look at how increasing the heart rate affects the amount of blood the heart pumps each minute, another key factor in a person's ability to perform physical activity. The investigators will examine 20 patients using a heart catheter to measure pressures, along with breathing analyses. During the measurements, all patients will perform light-intensity cycling. If increasing the pacemaker rate lowers the pressure in the heart, this simple, non-drug-based intervention could improve daily functioning and comfort for thousands of patients with heart failure, justifying further long-term studies to evaluate effects beyond the immediate changes in heart pressures.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12-10

Completion Date

2027-01-01

Last Updated

2026-01-08

Healthy Volunteers

Conditions

HFpEF

Interventions

OTHER

Accelerated pacing with AV-delay optimization during rest and light intensity cycling

Patients will undergo one protocol at rest and two exercise protocols (10 Watts followed by 25 Watts). During each protocol, the pacemaker rate will be gradually increased in three stages. At each stage, intracardiac pressures and shear-wave velocity will be measured. In a final fourth stage, the pacemaker rate will return to the level associated with the lowest heart pressure, blood oxygen levels and oxygen uptake will be assessed.

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. HFA-PEFF score \>= 5 or 2. H2FPEF score \>= 6 or 3. EF \>= 50% and i. 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), 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. Episode of atrial fibrillation in the last 3 months 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

Locations (2)

Jessa Ziekenhuis Hasselt

Hasselt, Belgium

University Hospitals Leuven

Leuven, Belgium