Tests macitentan with dapagliflozin in heart failure and lung blood pressure
Tests macitentan plus dapagliflozin in adults with heart failure and high lung blood pressure.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Busan, Chungju, Daegu, Daejeon, Gwangju, Incheon, Seoul, Wŏnju, and Yangsan, South KoreaSee the 15 sites
- Phase
- Phase 4
Where in South Korea
- Pusan National University HospitalBusan, South KoreaTaking people
- Chungbuk National University HospitalChungju, South KoreaNot yet recruiting
- Keimyung University Dongsan HospitalDaegu, South KoreaTaking people
- Chungnam National University HospitalDaejeon, South KoreaTaking people
- Chonnam National University HospitalGwangju, South KoreaTaking people
- Gachon University Gil HospitalIncheon, South KoreaTaking people
- Incheon Sejong HospitalIncheon, South KoreaNot yet recruiting
- Asan Medical CenterSeoul, South KoreaTaking people
- Koera University Guro HospitalSeoul, South KoreaNot yet recruiting
- Samsung Medical CenterSeoul, South KoreaNot yet recruiting
- Seoul National University HospitalSeoul, South KoreaTaking people
- The Catholic University of Korea, Seoul St.MarySeoul, South KoreaTaking people
- Yonsei University Health System, Severance HospitalSeoul, South KoreaNot yet recruiting
- Yonsei University Wonju Severance Christian HospitalWŏnju, South KoreaTaking people
- Pusan National University Yangsan HospitalYangsan, South KoreaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gachon University Gil Medical Center
- Trial code
- NCT07147114
- Record updated
- 3 April 2026
- Original description
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).Read full original descriptionShow less
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)
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).
The study will measure changes in pulmonary vascular resistance, NT-proBNP, 6-minute walk distance, and quality of life (KCCQ scores) over 24 weeks.
Participants will be randomly assigned to one of two groups, take study medication for 24 weeks, and undergo regular clinical, laboratory, and safety assessments.
Inclusion: <Screening Visit (Visit 1)>; A male or female adults aged 19 years or older in South Korea; LVEF greater than 40% on echocardiogram performed within 12 weeks prior to screening; 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); Meeting all of the following criteria on RHC performed within 48 weeks prior to screening:; mPAP > 20 mmHg; PVR > 2 Wood units (WU); PAWP > 15 mmHg; World Health Organization Functional Class (WHO-FC) II or III at the time of screening; 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:; Renin-angiotensin system inhibitors; Beta-blockers; Mineralocorticoid receptor antagonists (aldosterone antagonists); Sodium-glucose cotransporter-2 (SGLT2) inhibitors; Ivabradine; <Baseline Visit (Visit 2)>; World Health Organization Functional Class (WHO-FC) II or III at the time of baseline visit.
Exclusion: 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); *: 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; Participants who meet the following criteria on RHC performed within 12 weeks prior to screening:; PAWP ≤ 15 mmHg; History of any of the following medical conditions, surgeries, or procedures:; Myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention (PCI) within 3 months prior to screening; Uncontrolled tachycardia (>110 bpm) due to atrial fibrillation or atrial flutter; History of heart transplantation or implantation of a ventricular assist device, or planned to undergo such procedures; Urinary tract infection, genital infection (including fungal infections), or voiding disorder within 24 weeks prior to screening; Participation in another clinical trial involving administration/application of an investigational medicinal product or medical device within 3 months prior to screening; <Baseline Visit (Visit 2)>; Known hypersensitivity to the active ingredients (Macitentan, Dapagliflozin) or any excipients of the investigational medicinal product; Participants with type 1 diabetes mellitus or secondary diabetes mellitus; Participants diagnosed with pulmonary hypertension other than WHO Group 2 pulmonary hypertension (i.e., WHO Group 1, 3, 4, or 5); Group 1: Pulmonary arterial hypertension; Group 3: Pulmonary hypertension associated with lung diseases and/or hypoxia; Group 4: Chronic thrombo-embolic pulmonary hypertension; Group 5: Pulmonary hypertension with unclear and/or multifactorial mechanisms; Known hypersensitivity to soybean oil or history of soybean oil allergy; Known hypersensitivity to soy or peanuts; Participants who, upon re-confirmation of inclusion/exclusion criteria at the baseline visit, have any disqualifying condition; Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this clinical trial; History of taking any of the following medications within 4 weeks prior to screening:; Calcium channel blockers; Endothelin receptor antagonists; Phosphodiesterase type 5 inhibitors (PDE5i); Riociguat; Prostacyclin (PC) analogs or prostacyclin receptor agonists; Activin signaling inhibitors; eGFR ≤ 30 mL/min/1.73 m² or AST or ALT ≥ 2.5 × ULN; Hemoglobin < 9 g/dL at the time of screening; Participants with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption; <Screening Visit (Visit 1)>; Participants with metabolic acidosis, such as diabetic ketoacidosis.