Clinical trial NCT06992089: SHort Of Pace - Heart Failure (SHOP-HF)
Official title: Pacemaker Implantation in Patients With Heart Failure With Preserved Ejection Fraction, Chronotropic Incompetence and Small Ventricular Volume. The SHOP-HF Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Peak oxygen uptake
timeFrame: 3 months after the pacemarker stimulation
Secondary outcomes:
measure: Minnesota Living with Heart Failure Questionnaire (MLHFQ)
timeFrame: From randomization until the end of study in month 7
measure: E/E' ratio
timeFrame: From baseline until the end of study in month 7
measure: Left ventricular volume index
timeFrame: From baseline until the end of study in month 7
measure: Left atrial volume index
timeFrame: From baseline until the end of study in month 7
measure: Pro-B-type natriuretic peptide
timeFrame: From baseline until the end of study in month 7
measure: Serum carbohydrate antigen 125
timeFrame: From baseline until the end of study in month 7
Other outcomes:
measure: Acute HF hospitalizations
timeFrame: From baseline until the end of study in month 7
measure: Worsening HF not requiring hospitalization
timeFrame: From baseline until the end of study in month 7
measure: Mortality
timeFrame: From baseline until the end of study in month 7
Locations:
Study officials:
affiliation: Hospital Clínico Universitario de Valencia
name: Julio Núñez, Doctor
role: PRINCIPAL_INVESTIGATOR
References: