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)
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Combined Pre- and Post-capillary Pulmonary Hypertension, CpcPH, HFmrEF, HFpEF, Group 2 Pulmonary Hypertension
In brief
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.
Key facts
- Study ID
- NCT07147114
- Run by
- Gachon University Gil Medical Center
- People needed
- 64
- Starts
- 2025-11-24
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2026-04-03
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- <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
You may not qualify if…
- <Screening Visit (Visit 1)>
- Known hypersensitivity to the active ingredients (Macitentan, Dapagliflozin) or any excipients of the investigational medicinal product
- 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 with type 1 diabetes mellitus or secondary diabetes mellitus
- Participants with metabolic acidosis, such as diabetic ketoacidosis
- 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
- Participants who meet the following criteria on RHC performed within 12 weeks prior to screening:
- a. PAWP ≤ 15 mmHg
- 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
- 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
- eGFR ≤ 30 mL/min/1.73 m² or AST or ALT ≥ 2.5 × ULN
Where it is running
- Pusan National University Hospital — Busan, South Korea (enrolling)
- Chonnam National University Hospital — Gwangju, South Korea (enrolling)
- Gachon University Gil Hospital — Incheon, South Korea (enrolling)
- Seoul National University Hospital — Seoul, South Korea (enrolling)
- Asan Medical Center — Seoul, South Korea (enrolling)
- The Catholic University of Korea, Seoul St.Mary — Seoul, South Korea (enrolling)
- Yonsei University, Wonju Severance Christian Hospital — Wŏnju, South Korea (enrolling)
- Keimyung University Dongsan Hospital — Daegu, South Korea (enrolling)
- Chungnam National University Hospital — Daejeon, South Korea (enrolling)
- Chungbuk National University Hospital — Chungju, South Korea
- Pusan National University Yangsan Hospital — Yangsan, South Korea
- Yonsei University Health System, Severance Hospital — Seoul, South Korea
- Koera University Guro Hospital — Seoul, South Korea
- Incheon Sejong Hospital — Incheon, South Korea
- Samsung Medical Center — Seoul, South Korea
Full record on ClinicalTrials.gov
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