Actively Recruiting
SHort Of Pace - Heart Failure (SHOP-HF)
Led by Fundación para la Investigación del Hospital Clínico de Valencia · Updated on 2025-12-12
30
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SHort Of Pace - Heart Failure (SHOP-HF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Stable symptomatic heart failure with NYHA functional class II or higher during the last month
- Diagnosis of HFpEF according to ESC guidelines with symptoms and signs of heart failure
- Left ventricular ejection fraction of 50% or higher by Simpson method
- ProBNP level greater than 125 pg/mL in the last month
- Presence of left ventricular hypertrophy (wall thickness over 10 mm) and/or left atrial enlargement, or diastolic dysfunction
- Small ventricular volume defined as indexed left ventricular end diastolic volume less than 45 ml/m2
- Previous hospital admission for acute heart failure
- Chronotropic incompetence defined by cardiopulmonary exercise testing (CPET) as [(HRmax - HRrest)]/[(220 - age) - (HRrest)] less than 0.62
- Resting heart rate less than 65 bpm in sinus rhythm or less than 70 bpm in atrial fibrillation
You will not qualify if you...
- Inability to perform a valid baseline exercise test
- Significant primary pulmonary diseases such as pulmonary arterial hypertension, chronic thromboembolic pulmonary disease, or chronic obstructive pulmonary disease
- History of left ventricular ejection fraction below 50%
- Acute coronary syndrome within the previous 12 months
- Effort angina or signs of ischemia during CPET
- Respiratory exchange ratio (RER) threshold below 1.05 during CPET
- Moderate to severe primary valvular disease
- Any comorbidity with life expectancy less than 1 year
- Resting heart rate above 75 bpm
- Indications for other pacemaker use
- Pregnancy
- Baseline heart rhythm other than sinus rhythm or atrial fibrillation
- Current treatment with beta-blockers, digitalis, or non-dihydropyridine calcium channel blockers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Clínico de la Comunidad Valenciana
Valencia, Spain, 46010
Actively Recruiting
Research Team
J
Julio Núñez, Doctor
CONTACT
V
Vicente Bertomeu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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