Hospital Clínico de la Comunidad Valenciana
Valencia, 46010, Spain
Location status: Recruiting
NCT Number: NCT06992089
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Valencia, 46010, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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®).
Time frame: 3 months after the pacemarker stimulation
The primary endpoint of the study is absolute and relative changes in peak oxygen uptake (peakVO2) after three months of pacemaker stimulation.
Time frame: From randomization until the end of study in month 7
Absolute changes in quality of live assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time frame: From baseline until the end of study in month 7
Absolute changes in echocardiogram parameters (E/E' ratio)
Time frame: From baseline until the end of study in month 7
Absolute changes in echocardiogram parameters (Left ventricular volume index)
Time frame: From baseline until the end of study in month 7
Absolute changes in echocardiogram parameters (Left atrial volume index)
Time frame: From baseline until the end of study in month 7
Absolute and relative changes in prognostic biomarkers (pro-B-type natriuretic peptide)
Time frame: From baseline until the end of study in month 7
Absolute and relative changes in prognostic biomarkers (serum carbohydrate antigen 125).
Time frame: From baseline until the end of study in month 7
Total number of episodes of acute HF hospitalizations.
Time frame: From baseline until the end of study in month 7
Total episodes of worsening HF not requiring hospitalization
Time frame: From baseline until the end of study in month 7
Mortality
Interested in participating?
Request InfoFundación para la Investigación del Hospital Clínico de Valencia
Other
Pacemaker Implantation in Patients With Heart Failure With Preserved Ejection Fraction, Chronotropic Incompetence and Small Ventricular Volume. The SHOP-HF Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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