SHort Of Pace - Heart Failure (SHOP-HF)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®).
- Who it may be relevant to
- Registry conditions: Heart Failure With Preserved Ejection Fraction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pacemaker Implantation in Patients With Heart Failure With Preserved Ejection Fraction, Chronotropic Incompetence and Small Ventricular Volume. The SHOP-HF Trial
Overview
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.
Interventions
- Device Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®)
Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), with rate-adaptive pacing of the right atrium. There will be an associated right atrial lead (INGEVITY™ MRI Pacing Lead Boston®) and right ventricular lead (INGEVITY™ MRI Pacing Lead Boston®). Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®), with rate-adaptive pacing of the ventricles. There will be a right ventricular lead (INGEVITY™ MRI P Boston®).
Primary outcome measures
- Peak oxygen uptake [Time frame: 3 months after the pacemarker stimulation]
Secondary outcome measures (6)
- Minnesota Living with Heart Failure Questionnaire (MLHFQ) [Time frame: From randomization until the end of study in month 7]
- E/E' ratio [Time frame: From baseline until the end of study in month 7]
- Left ventricular volume index [Time frame: From baseline until the end of study in month 7]
- Left atrial volume index [Time frame: From baseline until the end of study in month 7]
- Pro-B-type natriuretic peptide [Time frame: From baseline until the end of study in month 7]
- Serum carbohydrate antigen 125 [Time frame: From baseline until the end of study in month 7]
Eligibility criteria
Inclusion criteria
- 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Clínico de la Comunidad Valenciana — Valencia
Identifiers
NCT: NCT06992089 · SHOP-HF