SHort Of Pace - Heart Failure (SHOP-HF)

ConditionHeart Failure With Preserved Ejection Fraction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorFundación para la Investigación del Hospital Clínico de Valencia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Stable symptomatic heart failure (NYHA functional class ≥II) during the last month.

symptoms and signs of HF.

left ventricular ejection fraction ≥50% by Simpson method.

proBNP >125 pg/mL in the last month.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®)
Device
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®).

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Pacing onExperimental treatment 1 intervention

Group B: Pacing offPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Peak oxygen uptake

The primary endpoint of the study is absolute and relative changes in peak oxygen uptake (peakVO2) after three months of pacemaker stimulation.

Time frame

3 months after the pacemarker stimulation

Secondary outcomes

Minnesota Living with Heart Failure Questionnaire (MLHFQ)

Absolute changes in quality of live assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ)

Time frame

From randomization until the end of study in month 7

E/E' ratio

Absolute changes in echocardiogram parameters (E/E' ratio)

Time frame