NCT06992089 SHort Of Pace - Heart Failure (SHOP-HF)
| NCT ID | NCT06992089 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación para la Investigación del Hospital Clínico de Valencia |
| Condition | Heart Failure With Preserved Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-06-17 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-06-17 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Julio Núñez, Doctor
PRINCIPAL INVESTIGATOR
Hospital Clínico Universitario de Valencia
Frequently Asked Questions
Who can join the NCT06992089 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Preserved Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06992089 currently recruiting?
Yes, NCT06992089 is actively recruiting participants. Contact the research team at yulnunez@gmail.es for enrollment information.
Where is the NCT06992089 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT06992089 clinical trial?
NCT06992089 is sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. The principal investigator is Julio Núñez, Doctor at Hospital Clínico Universitario de Valencia. The trial plans to enroll 30 participants.
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