[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Gachon University Gil Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100604253","phase-4-clinical-trial-to-evaluate-the-efficacy-and-safety-in-concomitant-administration-of-macitentan-and-dapagliflozin-in-patients-with-heart-failure-with-mildly-reduced-and-preserved-ejection-fraction-hfmref-and-hfpef-and-combined-pre--and-post-capillary-pulmonary-hypertension-cpcph-100604253",false,"NCT07147114","Clinical Trial to Evaluate the Efficacy and Safety in Concomitant Administration of Macitentan and Dapagliflozin in Patients With Heart Failure With Mildly Reduced and Preserved Ejection Fraction (HFmrEF and HFpEF) and Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH)","A Multicenter, Randomized, Double-Blind, Exploratory Clinical Trial to Evaluate the Efficacy and Safety in Concomitant Administration of Macitentan and Dapagliflozin in Patients With Heart Failure With Mildly Reduced and Preserved Ejection Fraction (HFmrEF and HFpEF) and Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH)","Inclusion Criteria:\n\n\\\u003CScreening Visit (Visit 1)\\>\n\n1. A male or female adults aged 19 years or older in South Korea\n2. LVEF greater than 40% on echocardiogram performed within 12 weeks prior to screening\n3. Presence of heart failure with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF) accompanied by combined pre- and post-capillary pulmonary hypertension (CpcPH)\n4. Meeting all of the following criteria on RHC performed within 48 weeks prior to screening:\n\n   1. mPAP \\> 20 mmHg\n   2. PVR \\> 2 Wood units (WU)\n   3. PAWP \\> 15 mmHg\n5. World Health Organization Functional Class (WHO-FC) II or III at the time of screening\n6. If taking any of the following medications at the time of screening, the participant must have been on a stable dose for at least 3 months:\n\n   1. Renin-angiotensin system inhibitors\n   2. Beta-blockers\n   3. Mineralocorticoid receptor antagonists (aldosterone antagonists)\n   4. Sodium-glucose cotransporter-2 (SGLT2) inhibitors\n   5. Ivabradine\n\n\\\u003CBaseline Visit (Visit 2)\\>\n\n1\\. World Health Organization Functional Class (WHO-FC) II or III at the time of baseline visit\n\nExclusion Criteria:\n\n\\\u003CScreening Visit (Visit 1)\\>\n\n1. Known hypersensitivity to the active ingredients (Macitentan, Dapagliflozin) or any excipients of the investigational medicinal product\n2. Pregnant or breastfeeding women, or those who do not agree to use at least two appropriate contraceptive methods\\* (self or partner) during the clinical trial period and for 30 days after the last administration of the investigational medicinal product (for male participants, those who do not agree to refrain from sperm donation)\n\n   \\*: a. Surgical sterilization (e.g., vasectomy) or intrauterine device (IUD; copper IUD or hormone-releasing intrauterine system), b. Non-oral hormonal contraceptive or spermicide in combination with a barrier method, c. Cervical cap or diaphragm used in combination with a male condom.\n3. Participants with type 1 diabetes mellitus or secondary diabetes mellitus\n4. Participants with metabolic acidosis, such as diabetic ketoacidosis\n5. Participants diagnosed with pulmonary hypertension other than WHO Group 2 pulmonary hypertension (i.e., WHO Group 1, 3, 4, or 5)\n\n   1. Group 1: Pulmonary arterial hypertension\n   2. Group 3: Pulmonary hypertension associated with lung diseases and\u002For hypoxia\n   3. Group 4: Chronic thrombo-embolic pulmonary hypertension\n   4. Group 5: Pulmonary hypertension with unclear and\u002For multifactorial mechanisms\n6. Participants who meet the following criteria on RHC performed within 12 weeks prior to screening:\n\n   a. PAWP ≤ 15 mmHg\n7. History of taking any of the following medications within 4 weeks prior to screening:\n\n   1. Calcium channel blockers\n   2. Endothelin receptor antagonists\n   3. Phosphodiesterase type 5 inhibitors (PDE5i)\n   4. Riociguat\n   5. Prostacyclin (PC) analogs or prostacyclin receptor agonists\n   6. Activin signaling inhibitors\n8. History of any of the following medical conditions, surgeries, or procedures:\n\n   1. Myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention (PCI) within 3 months prior to screening\n   2. Uncontrolled tachycardia (\\>110 bpm) due to atrial fibrillation or atrial flutter\n   3. History of heart transplantation or implantation of a ventricular assist device, or planned to undergo such procedures\n9. eGFR ≤ 30 mL\u002Fmin\u002F1.73 m² or AST or ALT ≥ 2.5 × ULN\n10. Urinary tract infection, genital infection (including fungal infections), or voiding disorder within 24 weeks prior to screening\n11. Hemoglobin \\\u003C 9 g\u002FdL at the time of screening\n12. Participants with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n13. Known hypersensitivity to soybean oil or history of soybean oil allergy\n14. Known hypersensitivity to soy or peanuts\n15. Participation in another clinical trial involving administration\u002Fapplication of an investigational medicinal product or medical device within 3 months prior to screening\n\n\\\u003CBaseline Visit (Visit 2)\\>\n\n1. Participants who, upon re-confirmation of inclusion\u002Fexclusion criteria at the baseline visit, have any disqualifying condition\n2. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this clinical trial","ALL","19 Years",{"count":19,"type":20},64,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This clinical trial will evaluate whether combination therapy with Dapagliflozin + Macitentan improves outcomes compared to Dapagliflozin + placebo in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH).\n\nThe study will measure changes in pulmonary vascular resistance, NT-proBNP, 6-minute walk distance, and quality of life (KCCQ scores) over 24 weeks.\n\nParticipants will be randomly assigned to one of two groups, take study medication for 24 weeks, and undergo regular clinical, laboratory, and safety assessments.",[26,27,28,29,30],"Combined Pre- and Post-capillary Pulmonary Hypertension","CpcPH","HFmrEF","HFpEF","Group 2 Pulmonary Hypertension","RECRUITING","2026-03-30",{"date":34,"type":35},"2026-04-03","ACTUAL",{"date":37,"type":35},"2025-11-24",{"date":39,"type":20},"2027-09-30",{"name":41,"class":42},"Gachon University Gil Medical Center","OTHER",15,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100601522","personalized-health-coaching-for-patients-with-hf-100601522","NCT07111585","Personalized Health Coaching for Patients With HF","Effect of Personalized Health Coaching Program in Patients With Frailty and Heart Failure","Coach-FrailHF","Inclusion Criteria:\n\n* Participants aged 40 years or older will be included in the study, as heart failure (HF)-related mortality and the prevalence of HF increase significantly from this age onward. Inclusion criteria requires a diagnosis of acute HF by a cardiologist and hospitalization based on the following criteria: presence of HF symptoms (e.g., breathlessness, fatigue, ankle swelling) and signs (e.g., elevated jugular venous pressure, pulmonary crackles, peripheral edema), evidence of pulmonary congestion or edema on chest X-ray, and elevated levels of BNP (≥100 pg\u002FmL) or NT-proBNP (≥300 pg\u002FmL). After initial screening for frailty using both the Tilburg Frailty Indicator (TFI) and Fried's Phenotype (FP), participants will be enrolled if they are classified as frail, able to cooperate with functional assessments, and willing to provide written informed consent with a clear understanding of the study's purpose and procedures.\n\nExclusion Criteria:\n\n* The exclusion criteria were as follows: current enrollment in other programs or planning to participate in similar programs during the intervention period; residing outside Korea and not understanding Korean; diagnosis of dementia with the Global Deterioration Scale stage of 5 or greater; inability to comprehend the study purpose and content.","40 Years",{"count":54,"type":20},80,[56],"NA","Frailty in heart failure (HF) patients contributes to poor outcomes, emphasizing the need for effective management. In many previous studies, frailty interventions have mainly targeted physical frailty or focused community-dwelling patients, neglecting the multidimensional needs of hospitalized individuals. As a frailty for HF patients need to include clinical, functional, cognitive, and social domains, nurses must assess it holistically and provide personalized support, especially during care transitions. This study aims to evaluate the effectiveness of a nurse-led, personalized health coaching program for hospitalized HF patients with frailty through a randomized controlled trial. This 12-week intervention program targets hospitalized HF patients with frailty. After screening frailty HF patients using validated tools such as Fried's phenotype (FP), Tilburg Frailty Indicator (TFI), participants will be randomly assigned to either an intervention or control group. The intervention group will receive personalized health services, including pre-discharge education and weekly telephone coaching, addressing clinical, functional, psycho-cognitive, and social frailty domains. Psychiatric support and community integration program will be provided as needed. The control group will receive standard care. Frailty, QoL, and clinical outcomes will be measured at baseline, 12 weeks, and 24 weeks. The primary outcomes will be improvements in frailty and QoL. Frailty will be measured both multidimensional and each of the four domains of frailty for HF patients. This study will clarify the role of multidimensional personalized interventions in addressing adverse outcomes related to frailty in patients with HF, thereby providing evidence of their necessity in its management.",[59,60,61,62,63,64],"Heart Failure","Frailty","Health Coaching","Telenursing","Patient Monitoring","Randomized Controlled Trial","2025-08-07",{"date":67,"type":35},"2025-08-08",{"date":69,"type":35},"2025-07-03",{"date":71,"type":20},"2027-06",{"name":41,"class":42},1,""]