[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474925":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":39,"responsibleParty":70,"collaborators":11,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":11,"enrollmentInfo":83,"targetDuration":11,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":11,"overallStatus":93,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Heidelberg University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Exercise training","ACTIVE_COMPARATOR",null,[13],"Other: Exercise rehabilitation",{"label":15,"type":16,"description":11,"interventionNames":17},"Standard treatment (waiting group)","PLACEBO_COMPARATOR",[18],"Other: Standard treatment",[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"Exercise rehabilitation","The initial phase of exercise training will be closely monitored and will be based on a three-weeks in-hospital stay to adjust and teach the exercise training which will be continued at home for 12 more weeks. In-hospital stays will be arranged country specific and hospitalization time may range. The rehabilitation program comprises of interval ergometer training (20 minutes 5 days per week), dumbbell training (30 minutes 5 days per week), respiratory therapy (30 minutes 5 days per week), mental training and guided walks for 2-5 times\u002Fweek.",[9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Standard treatment","Standard treatment during study duration",[15],[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Ekkehard Grünig, MD","CONTACT","+496221396","1288","ekkehard.gruenig@med.uni-heidelberg.de",{"name":36,"role":31,"phone":37,"phoneExt":33,"email":38},"Nicola Benjamin, MSc","+49 6221 396","nicola.benjamin@med.uni-heidelberg.de",[40,57],{"facility":41,"status":11,"city":42,"state":11,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Centre for Pulmonary Hypertension at the Thoraxklinik Heidelberg, Heidelberg University Hospital","Heidelberg","69126","Germany","DE",{"type":47,"coordinates":48},"Point",[49,50],8.69079,49.40768,{"lat":50,"lon":49},[53,55],{"name":30,"role":31,"phone":32,"phoneExt":54,"email":34},"8053",{"name":30,"role":56,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"facility":58,"status":11,"city":59,"state":11,"zip":11,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania","Vilnius","Lithuania","LT",{"type":47,"coordinates":63},[64,65],25.2798,54.68916,{"lat":65,"lon":64},[68],{"name":69,"role":31,"phone":11,"phoneExt":11,"email":11},"Egle Paleviciute",{"type":56,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Prof. Dr. med. Ekkehard Gruenig","Head of pulmonary hypertension centre, Thoraxklinik Heidelberg GgmbH","100474925","training-in-hfpef-ph-100474925",false,"NCT05464238","Training in HFpEF-PH","Implementation, Safety, Tolerability and Effect of Exercise and Respiratory Training on 6-minute Walking Distance in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (HFpEF): a Randomized Controlled Multicenter Trial in European Countries.","TRAIN HFpEF","Inclusion Criteria:\n\n1. Female and male patients ≥18 years\n2. WHO\u002FNYHA functional class II - IV\n3. PH with HFpEF diagnosed by right heart catheterisation showing:\n\n   mean pulmonary arterial pressure (mPAP) ≥25mmHg at rest; pulmonary arterial wedge pressure (PAWP) ≥15mmHg at rest or LVEDP ≥16mmHg and\u002For PAWP≥25 mmHg during exercise, and\n4. Preserved left ventricular ejection fraction ≥50%\n5. Patients receiving optimized therapy including intensified treatment with diuretics and who have been stable for 1 month before entering the study.\n6. Except for diuretics, medical treatment should not be changed during the study period.\n7. Able to understand and willing to sign the Informed Consent Form\n\nExclusion Criteria:\n\n1. Pre-capillary pulmonary hypertension (Group I; Group III; Group IV; Group V according to PH guidelines)\n2. Congenital or acquired severe valvular diseases (severe aortic stenosis or insufficiency, severe mitral valve stenosis or insufficiency)\n3. Pregnancy or lactation\n4. Walking disability\n5. Subject who participates in an interventional study during the course of this study\n6. Severe lung disease: FEV1\u002FFVC \\\u003C0.5 and total lung capacity \\\u003C60% of the normal value\n7. Active myocarditis, unstable angina pectoris, exercise induced ventricular arrhythmias, active liver disease, porphyria or elevations of serum transaminases \\>3 x ULN (upper limit of normal) or bilirubin \\>1.5 x ULN\n8. Haemoglobin concentration less than 75% of the lower limit of normal\n9. Systolic blood pressure \\\u003C85 mmHg\n10. History or suspicion of inability to cooperate adequately.","ALL","18 Years",{"count":84,"type":85},90,"ESTIMATED","INTERVENTIONAL",[88],"NA","Exercise interventions alone or as a component of a comprehensive cardiac rehabilitation program for patients with heart failure (HFrEF and HFpEF) have already shown to reduce the risk of hospitalisations due to HF and improved exercise capacity and health-related quality of life. Two meta-analyses have confirmed the beneficial effects in cardiorespiratory fitness and quality of life. The effects of exercise training on systolic and diastolic function remain inconclusive. Due to the positive results of exercise training in HFpEF, cardiac rehabilitation is recommended (Class I, level A) to be integrated into the overall provision of HF care. However, none of these studies focused on concomitant PH in HFpEF.\n\nExercise training in patients with pulmonary hypertension has already shown to improve exercise capacity, quality of life and peak oxygen consumption, which was confirmed by three meta-analyses and a Cochrane review. Though different diagnostic subgroups have already been enrolled in PH exercise training studies, they mainly included pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Data on combined PH and HFpEF is still lacking.\n\nAs recently pointed out by Arena et al. there may thus be an exercise training volume\u002Fintensity which may be detrimental to the RV in patients with HF and concomitant PH.\n\nThis study is sought to investigate whether a specialized training program is safe and tolerable and may improve exercise capacity, quality of life, hemodynamics, diastolic dysfunction and biomarkers in patients with PH and HFpEF.",[91,92],"Pulmonary Hypertension Due to Left Heart Disease","Heart Failure With Preserved Ejection Fraction","NOT_YET_RECRUITING","2022-09-14",{"date":96,"type":97},"2022-09-16","ACTUAL",{"date":99,"type":85},"2023-02-01",{"date":101,"type":85},"2026-12",{"name":5,"class":6},2]