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.
The first phase of the study is the screening phase. During this phase, the investigators will review all patients from the LBBA pacing registries at UZ Leuven and Jessa Hospital to identify who may be eligible. From this review, the investigators will create a list of potential candidates, who will then be contacted during their regular check-up visits, which take place at least once a year. If a patient is found to be eligible during this visit, the study visit will be scheduled within three weeks. If the patient remains eligible, the study tests will begin. A small tube (catheter) will be placed in a vein in the neck and in an artery in the wrist to measure heart pressures and blood oxygen levels. The patient will then be positioned on a slightly reclined stationary bike. During the test, the heart rate will be gradually increased in three steps by adapting the pacemaker settings, and at each step, the pressures inside the heart will be measured. In a final step, the heart rate will return to the level associated with the lowest heart pressure, and blood oxygen levels will be checked. This allows the research team to calculate how much oxygen the heart pumps per minute. After the exercise, the patient will rest briefly while the catheters are safely removed. The entire study visit lasts about three hours, after which participation ends. The full study is expected to be completed once 20 patients have finished all study tests, which should take approximately one year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
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.
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 pulmonary capillary wedge pressure at each pacing step compared to the pulmonary capillary wedge pressure at the intrinsic heart rate at rest and during exercise (cycling at 10 Watts and 25 Watts). The PCWP at the intrinsic heart rate is defined as the average of the PCWP at the intrinsic heart rate heart rate before and after each pacing step.
Time frame: Intraprocedural
Cardiac output, measured using the direct Fick principle
The change in cardiac output (CO), measured by the direct Fick principle, at the pacing frequency corresponding to the greatest reduction in PCWP compared to the intrinsic heart rate at rest and during exercise (cycling at 10 Watts and 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 intrinsic heart rate at rest and during exercise (cycling at 10 Watts and 25 Watts) The shear wave velocity at the intrinsic heart rate is defined as the average of the SWV at the intrinsic 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 intrinsic heart rate at rest and during exercise (cycling at 10 Watts and 25 Watts)
Time frame: Intraprocedural
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