Short Of Pace: Pacemaker pacing for heart failure with preserved ejection fraction

Is this trial a fit for you?

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

What this trial studies

The trial is a multicenter, prospective, randomized, blinded crossover design in which all participants receive a CE‑marked Boston Scientific pacemaker and are randomized to 3 months with pacing programmed On followed by 3 months Off, or the reverse sequence. Each participant therefore serves as their own control during two 3‑month periods, with blinding of pacing status. Eligible patients have HFpEF with left ventricular hypertrophy, small ventricular volumes, low resting heart rate and documented chronotropic incompetence. The study focuses on symptomatic, stable HFpEF patients and uses device programming changes rather than different implanted devices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Stable symptomatic heart failure (NYHA functional class ≥II) during the last month.
* Diagnosis criteria of HFpEF according to ESC guidelines:

  1. symptoms and signs of HF.
  2. left ventricular ejection fraction ≥50% by Simpson method.
  3. proBNP \>125 pg/mL in the last month.
  4. at least one additional criterion: 1. relevant structural heart disease (left ventricular hypertrophy and/or left atrial enlargement); and/or 2. Diastolic dysfunction.
* Left ventricular hypertrophy was defined as wall thickness \> 10 mm.
* Small ventricular volume was defined as indexed left ventricular end diastolic volume \< 45 ml/m2.
* Adults ≥18 years old.
* Previous admission for acute heart failure.
* Chronotropic incompetence assessed by CPET, defined as: \[(HRmax - HRrest)\]/\[(220 - age) - (HRrest)\] \< 0.62.
* Resting heart rate \< 65 bpm in sinus rhythm or 70 bmp in atrial fibrillation.

Exclusion Criteria:

* Inability to perform a valid baseline exercise test.
* Significant primary pulmonary disease; including pulmonary arterial hypertension, chronic thromboembolic pulmonary disease or chronic obstructive pulmonary disease.
* Patient with prior history of left ventricular ejection fraction \<50%.
* History of an acute coronary syndrome in the previous 12 months.
* Effort angina or signs of ischemia during CPET.
* RER threshold at \<1.05 at the CPET.
* Significant primary moderate to severe valvular disease.
* Any other comorbidity with a life expectancy lower than 1 year.
* Heart rate at rest \> 75 lpm.
* Other pacemaker indication.
* Pregnant women.
* Baseline rhythm different from sinus rhythm or atrial fibrillation.
* Active treatment with beta-blockers, digitalis or non dihidropiridine calcium channel blockers.

Where it's running

• Hospital Clínico de la Comunidad Valenciana
  Valencia, Spain Recruiting

Study contacts

• Principal investigator: Julio Núñez, Doctor — Hospital Clínico Universitario de Valencia
• Study coordinator: Julio Núñez, Doctor
• Email: yulnunez@gmail.es
• Phone: 652856689

Similar studies

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

• Remote rehabilitation for HFpEF patients using telerehabilitation

  A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.

  Recruiting at 3 sites American Heart of Poland · Chrzanów and 2 other locations · NCT07918209

• EDG-15400 in adults with HFpEF: a phase 2 study

  This phase 2 study tests different doses of EDG-15400 against placebo in adults with HFpEF to see if it is safe and tolerable.

  Recruiting at 4 sites Phase 2 Edgewise Therapeutics, Inc. · Birmingham, Alabama and 27 other locations · NCT07795814

• Incretin therapy with tirzepatide for obesity-related HFpEF

  A 15-month study will test whether tirzepatide helps people with obesity and HFpEF by reducing plasma volume.

  Recruiting Phase 4 Columbia University · New York, New York · NCT07554638

• Boosted exercise with group coaching for HFpEF

  This trial tests a blended, guided exercise program with group coaching and remote monitoring to see if it helps older adults with HFpEF improve activity and health at a lower cost.

  Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT07413198

• Exercise cardiac MRI for heart failure with preserved ejection fraction

  This study will try low-field exercise cardiac MRI to see if it can diagnose, describe, and predict risk in people with HFpEF compared with those who have non-cardiac breathlessness and healthy volunteers.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07401771

• HRS-1893 for heart failure with preserved ejection fraction

  This trial will test whether HRS-1893 is safe and tolerable in adults aged 40 and older who have heart failure with preserved ejection fraction.

  Recruiting Phase 2 Shandong Suncadia Medicine Co., Ltd. · Shanghai, Shanghai Municipality · NCT07269717

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.