What is HFpEF? In heart failure with preserved ejection fraction (HFpEF), the heart pumps well but struggles to relax and fill with blood between beats. This raises the pressure inside the heart, especially during physical activity, causing symptoms like shortness of breath and fatigue - even with light activities like walking or climbing stairs. What is this study about? Recent research suggests that a higher heart rate may help lower this elevated pressure. Many HFpEF patients already have a pacemaker. This study investigates whether simply increasing the pacemaker rate during light exercise can reduce the pressure in the heart. How does the study work? We wille measure heart pressures in 20 patients in rest and while cycling using a heart catheter and monitor their breathing. Throughout these measurements, we will gradually increase the pacemaker rate step by step. Why does this matter? If a higher pacemaker rate successfully lowers heart pressure, this could offer a simple, drug-free way to improve daily functioning and comfort for thousands of patients with HFpEF, justifying further long-term studies to evaluate effects beyond the immediate changes in heart pressures.
First, we will review patient records to identify eligible participants, who will then be contacted during their regular check-up visit. If they are interested in participating, they will be invited for an additional screening visit if needed. Patients who meet the eligibility criteria will be invited for an invasive exercise test. At this visit, two small tubes (catheters) will be placed, one in a neck vein and one in a wrist artery, to measure heart pressures and blood oxygen levels. The patient then sits on a reclined stationary bike, wearing a breathing mask to monitor oxygen uptake. Throughout the visit, ultrasound measurements of the heart will also be performed. First, heart pressures are measured at rest while the pacemaker rate is gradually increased in three steps (+20, +40, +60 beats per minute). Second, the patient cycles gently while the same measurements are repeated, with the pacemaker rate increased in three steps (+10, +30, +50 beats per minute). In a final step of both the rest and exercise protocol, the heart rate will return to the level associated with the lowest heart pressure, and blood oxygen levels will be checked, allowing the research team to calculate how many liters of blood the heart pumps per minute. Afterward, the catheters are safely removed and the pacemaker settings are restored to their original values. This visit is expected to last about three hours, after which study participation ends. The full study is expected to be completed once 20 patients have finished all study tests.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Patients will undergo one resting and one exercise protocol (25 Watts). During each protocol, the pacemaker rate will be gradually increased in three stages: +20, +40, +60 bpm at rest and +10, +30, +50 bpm during exercise. At each stage, intracardiac pressures and shear-wave velocity will be measured. In a final fourth stage, the pacemaker rate returns to the level associated with the lowest filling pressure, after which blood oxygen levels and oxygen uptake are assessed to calculate cardiac output.
Jessa Ziekenhuis Hasselt
Hasselt, Belgium
RECRUITINGUniversity Hospitals Leuven
Leuven, Belgium
RECRUITINGPulmonary capillary wedge pressure (PCWP), measured using a Swan-Ganz catheter (pulmonary artery catheter).
The change in PCWP at each pacing frequency (+20 bpm, +40 bpm, +60 bpm) with its corresponding optimal AV-delay at rest, compared to baseline PCWP. The change in PCWP at each pacing frequency (+10 bpm, +30 bpm, +50 bpm) using dynamic AV-delay programming, while avoiding truncation, compared to baseline PCWP during exercise (cycle ergometry at 25 W) Baseline PCWP is calculated as the average of the measurements before and after each accelerated pacing-on step, using the intrinsic HR or baseline atrial pacing rate as the reference HR, as applicable
Time frame: Intraprocedural
Cardiac output, measured using the direct Fick principle
The change in CO, measured by the direct Fick principle, at the pacing frequency corresponding to the greatest reduction in PCWP compared to the reference HR at rest and during exercise (cycling at 25 Watts)
Time frame: Intraprocedural
Shear wave velocity, measured via echocardiographically obtained myocardial shear waves following mitral valve closure
The change in shear wave velocity (SWV) at each pacing rate compared to the reference heart rate at rest and during exercise (cycling at 25 Watts) The shear wave velocity at the reference heart rate is defined as the average of the SWV at the reference heart rate heart rate before and after each pacing step.
Time frame: Intraprocedural
Peripheral oxygen extraction
The change in peripheral oxygen extraction, measured by the oxygen uptake divided by the cardiac output, at the pacing frequency corresponding to the greatest reduction in pulmonary capillary wedge pressure compared to peripheral oxygen extraction at the reference heart rate at rest and during exercise (cycling at 25 Watts)
Time frame: Intraprocedural
Stroke volume
The change in stroke volume, measured by the cardiac output divided by the heart rate, at the pacing frequency corresponding to the greatest reduction in pulmonary capillary wedge pressure compared to stroke volume at the reference heart rate at rest and during exercise (cycling at 25 Watts)
Time frame: Intraprocedural
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