[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592335":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":46,"studyPopulation":46,"armGroups":52,"interventions":64,"overallOfficials":70,"centralContacts":75,"locations":83,"responsibleParty":100,"collaborators":46,"id":102,"slug":46,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":46,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":46,"enrollmentInfo":110,"targetDuration":46,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":46,"overallStatus":86,"whyStopped":46,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Fundación para la Investigación del Hospital Clínico de Valencia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"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.","3 months after the pacemarker stimulation",[14,18,22,25,28,31],{"measure":15,"description":16,"timeFrame":17},"Minnesota Living with Heart Failure Questionnaire (MLHFQ)","Absolute changes in quality of live assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ)","From randomization until the end of study in month 7",{"measure":19,"description":20,"timeFrame":21},"E\u002FE' ratio","Absolute changes in echocardiogram parameters (E\u002FE' ratio)","From baseline until the end of study in month 7",{"measure":23,"description":24,"timeFrame":21},"Left ventricular volume index","Absolute changes in echocardiogram parameters (Left ventricular volume index)",{"measure":26,"description":27,"timeFrame":21},"Left atrial volume index","Absolute changes in echocardiogram parameters (Left atrial volume index)",{"measure":29,"description":30,"timeFrame":21},"Pro-B-type natriuretic peptide","Absolute and relative changes in prognostic biomarkers (pro-B-type natriuretic peptide)",{"measure":32,"description":33,"timeFrame":21},"Serum carbohydrate antigen 125","Absolute and relative changes in prognostic biomarkers (serum carbohydrate antigen 125).",[35,38,41],{"measure":36,"description":37,"timeFrame":21},"Acute HF hospitalizations","Total number of episodes of acute HF hospitalizations.",{"measure":39,"description":40,"timeFrame":21},"Worsening HF not requiring hospitalization","Total episodes of worsening HF not requiring hospitalization",{"measure":42,"description":42,"timeFrame":21},"Mortality",{"allocation":44,"interventionModel":45,"interventionModelDescription":46,"primaryPurpose":47,"observationalModel":46,"timePerspective":46,"maskingInfo":48},"RANDOMIZED","CROSSOVER",null,"TREATMENT",{"masking":49,"maskingDescription":46,"whoMasked":50},"SINGLE",[51],"PARTICIPANT",[53,59],{"label":54,"type":55,"description":56,"interventionNames":57},"Pacing on","EXPERIMENTAL","Pacemarker stimulation programmed as AAIR \u002F DDDR \u002F VVIR with the basic stimulation frequency and the rate response as follows (pacing on):\n\n* Basic heart rate: derived from the averaged resting heart rates of healthy adults according to height and LVEF.\n* Rate response through a combination of minute ventilation and accelerometer: with a response factor of 3 and a medium-low activity threshold.",[58],"Device: Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®)",{"label":60,"type":61,"description":62,"interventionNames":63},"Pacing off","PLACEBO_COMPARATOR","VVI 30 bpm",[58],[65],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":46},"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®).\n\nSingle-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®).",[60,54],[71],{"name":72,"affiliation":73,"role":74},"Julio Núñez, Doctor","Hospital Clínico Universitario de Valencia","PRINCIPAL_INVESTIGATOR",[76,80],{"name":72,"role":77,"phone":78,"phoneExt":46,"email":79},"CONTACT","652856689","yulnunez@gmail.es",{"name":81,"role":77,"phone":46,"phoneExt":46,"email":82},"Vicente Bertomeu, Doctor","vbertog@gmail.com",[84],{"facility":85,"status":86,"city":87,"state":46,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Hospital Clínico de la Comunidad Valenciana","RECRUITING","Valencia","46010","Spain","ES",{"type":92,"coordinates":93},"Point",[94,95],-0.37966,39.47391,{"lat":95,"lon":94},[98],{"name":99,"role":77,"phone":46,"phoneExt":46,"email":46},"Julio Núñez Villota",{"type":101,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100592335",false,"NCT06992089","SHort Of Pace - Heart Failure (SHOP-HF)","Pacemaker Implantation in Patients With Heart Failure With Preserved Ejection Fraction, Chronotropic Incompetence and Small Ventricular Volume. The SHOP-HF Trial","Inclusion Criteria:\n\n* Stable symptomatic heart failure (NYHA functional class ≥II) during the last month.\n* Diagnosis criteria of HFpEF according to ESC guidelines:\n\n  1. symptoms and signs of HF.\n  2. left ventricular ejection fraction ≥50% by Simpson method.\n  3. proBNP \\>125 pg\u002FmL in the last month.\n  4. at least one additional criterion: 1. relevant structural heart disease (left ventricular hypertrophy and\u002For left atrial enlargement); and\u002For 2. Diastolic dysfunction.\n* Left ventricular hypertrophy was defined as wall thickness \\> 10 mm.\n* Small ventricular volume was defined as indexed left ventricular end diastolic volume \\\u003C 45 ml\u002Fm2.\n* Adults ≥18 years old.\n* Previous admission for acute heart failure.\n* Chronotropic incompetence assessed by CPET, defined as: \\[(HRmax - HRrest)\\]\u002F\\[(220 - age) - (HRrest)\\] \\\u003C 0.62.\n* Resting heart rate \\\u003C 65 bpm in sinus rhythm or 70 bmp in atrial fibrillation.\n\nExclusion Criteria:\n\n* Inability to perform a valid baseline exercise test.\n* Significant primary pulmonary disease; including pulmonary arterial hypertension, chronic thromboembolic pulmonary disease or chronic obstructive pulmonary disease.\n* Patient with prior history of left ventricular ejection fraction \\\u003C50%.\n* History of an acute coronary syndrome in the previous 12 months.\n* Effort angina or signs of ischemia during CPET.\n* RER threshold at \\\u003C1.05 at the CPET.\n* Significant primary moderate to severe valvular disease.\n* Any other comorbidity with a life expectancy lower than 1 year.\n* Heart rate at rest \\> 75 lpm.\n* Other pacemaker indication.\n* Pregnant women.\n* Baseline rhythm different from sinus rhythm or atrial fibrillation.\n* Active treatment with beta-blockers, digitalis or non dihidropiridine calcium channel blockers.","ALL","18 Years",{"count":111,"type":112},30,"ESTIMATED","INTERVENTIONAL",[115],"NA","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\u002FIV, left ventricular hypertrophy with small ventricular volume, sinus rhythm with low basal heart rate and chronotropic incompetence (CI).\n\nAll 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.",[118],"Heart Failure With Preserved Ejection Fraction","2025-12-05",{"date":121,"type":122},"2025-12-12","ACTUAL",{"date":124,"type":122},"2025-06-17",{"date":126,"type":112},"2026-06",{"name":5,"class":6},1]