Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07270536

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

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-01-08

20

Participants Needed

2

Research Sites

55 weeks

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

J

Jessa Ziekenhuis Hasselt

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary written informed consent before screening
  • Age 18 years or older
  • Heart failure with preserved ejection fraction defined by HFA-PEFF score ≥ 5 or H2FPEF score ≥ 6 or EF ≥ 50% with heart failure hospitalization after pacemaker implantation or on loop-diuretics at inclusion
  • DDD-pacemaker with left bundle branch area pacing implanted at least 12 weeks before testing
  • At least 6 weeks on optimal HFpEF therapy unless contraindicated or not tolerated
  • Sinus rhythm at time of screening and exercise test
Not Eligible

You will not qualify if you...

  • History of significant pulmonary disease (FEV1 < 60%) or lung abnormalities more than mild on imaging
  • Severe or symptomatic heart valve diseases
  • Severe pulmonary hypertension (PASP > 55mmHg)
  • Unstable arrhythmias such as ventricular tachycardia or fibrillation
  • Recurrent fainting after pacemaker implantation
  • Atrial fibrillation episode in the last 3 months
  • Amyloid cardiomyopathy
  • Physical inability to perform exercise
  • More than one heart failure hospitalization in the last year
  • Resting heart rate over 100 bpm
  • Decompensated heart failure or unstable coronary syndrome at inclusion
  • Contraindications to central venous access including severe coagulopathy, infections, thrombosis, or lung pathology
  • Contraindications to arterial access including thrombosis, vasospastic disorders, infection, severe coagulopathy, or insufficient collateral circulation
  • Contraindications to exercise testing including signs of myocardial injury, lethal arrhythmias, abnormal blood pressure, fainting symptoms, low oxygen saturation, or severely elevated heart pressure during exercise

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Jessa Ziekenhuis Hasselt

Hasselt, Belgium, 3500

Actively Recruiting

2

University Hospitals Leuven

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

M

Margot Vermeiren, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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