SHort Of Pace - Heart Failure (SHOP-HF)

Not Applicable

Not yet recruiting

• Conditions: Heart Failure With Preserved Ejection Fraction

• Registration Number: NCT06992089
• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

Brief Summary

This study is designed as a multicenter, prospective, controlled, randomized, two-arms, cross-over, two parallel cohorts, efficacy Clinical research with CE-marked medical device . The crossover trial will be performed in a blind fashion, so each participant will be evaluated during both blinded pacing-on and pacing-off phases, each of which will last 3 months. The population includes patients with the diagnosis of stable HFpEF according to criteria of the European Society of Cardiology and New York Heart Association (NYHA) functional class II-III/IV, left ventricular hypertrophy with small ventricular volume, sinus rhythm with low basal heart rate and chronotropic incompetence (CI).

All patients will undergo pacemaker implantation, and computer-generated randomization sequence previously designed will be used to allocate participants (in a 1:1 ratio) to receive: (a) programming of the pacemaker with pacing On followed by pacing Off in two periods of 3 months; or (b) programming of the pacemaker with pacing Off followed by pacing On in two periods of 3 months. The study will be conducted in three centers in Spain. Discounting the time due to staggered entry, the total duration of a patient's follow-up will be 7 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-19
• Study First Posted: 2025-05-28
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-03
• Last Update Posted: 2025-06-08
• Study Start: 2025-06-15
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Peak oxygen uptake	3 months after the pacemarker stimulation	The primary endpoint of the study is absolute and relative changes in peak oxygen uptake (peakVO2) after three months of pacemaker stimulation.

Secondary Outcome Measures

Name	Time	Method
Pro-B-type natriuretic peptide	From baseline until the end of study in month 7	Absolute and relative changes in prognostic biomarkers (pro-B-type natriuretic peptide)
Minnesota Living with Heart Failure Questionnaire (MLHFQ)	From randomization until the end of study in month 7	Absolute changes in quality of live assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ)
E/E' ratio	From baseline until the end of study in month 7	Absolute changes in echocardiogram parameters (E/E' ratio)
Left ventricular volume index	From baseline until the end of study in month 7	Absolute changes in echocardiogram parameters (Left ventricular volume index)
Left atrial volume index	From baseline until the end of study in month 7	Absolute changes in echocardiogram parameters (Left atrial volume index)
Serum carbohydrate antigen 125	From baseline until the end of study in month 7	Absolute and relative changes in prognostic biomarkers (serum carbohydrate antigen 125).