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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
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®).
Hospital Clínico de la Comunidad Valenciana
Valencia, Spain
RECRUITINGPeak 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
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: From baseline until the end of study in month 7
Left ventricular volume index
Absolute changes in echocardiogram parameters (Left ventricular volume index)
Time frame: From baseline until the end of study in month 7
Left atrial volume index
Absolute changes in echocardiogram parameters (Left atrial volume index)
Time frame: From baseline until the end of study in month 7
Pro-B-type natriuretic peptide
Absolute and relative changes in prognostic biomarkers (pro-B-type natriuretic peptide)
Time frame: From baseline until the end of study in month 7
Serum carbohydrate antigen 125
Absolute and relative changes in prognostic biomarkers (serum carbohydrate antigen 125).
Time frame: From baseline until the end of study in month 7
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