[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592335":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":39,"responsibleParty":56,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":25,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Fundación para la Investigación del Hospital Clínico de Valencia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®)",{"label":15,"type":16,"description":17,"interventionNames":18},"Pacing off","PLACEBO_COMPARATOR","VVI 30 bpm",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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®).",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Julio Núñez, Doctor","Hospital Clínico Universitario de Valencia","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","652856689","yulnunez@gmail.es",{"name":37,"role":33,"phone":25,"phoneExt":25,"email":38},"Vicente Bertomeu, Doctor","vbertog@gmail.com",[40],{"facility":41,"status":42,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hospital Clínico de la Comunidad Valenciana","RECRUITING","Valencia","46010","Spain","ES",{"type":48,"coordinates":49},"Point",[50,51],-0.37966,39.47391,{"lat":51,"lon":50},[54],{"name":55,"role":33,"phone":25,"phoneExt":25,"email":25},"Julio Núñez Villota",{"type":57,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100592335","short-of-pace---heart-failure-shop-hf-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":68,"type":69},30,"ESTIMATED","INTERVENTIONAL",[72],"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.",[75],"Heart Failure With Preserved Ejection Fraction","2025-12-05",{"date":78,"type":79},"2025-12-12","ACTUAL",{"date":81,"type":79},"2025-06-17",{"date":83,"type":69},"2026-06",{"name":5,"class":6},1]