Status:
RECRUITING
SHort Of Pace - Heart Failure (SHOP-HF)
Lead Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Stable symptomatic heart failure (NYHA functional class ≥II) during the last month.
- Diagnosis criteria of HFpEF according to ESC guidelines:
- symptoms and signs of HF.
- left ventricular ejection fraction ≥50% by Simpson method.
- proBNP \>125 pg/mL in the last month.
- 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
- 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.
Key Trial Info
Start Date :
June 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06992089
Start Date
June 17 2025
End Date
June 1 2026
Last Update
December 12 2025
Active Locations (1)
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1
Hospital Clínico de la Comunidad Valenciana
Valencia, Spain, 46010