Clinical Trial to Evaluate the Efficacy and Safety in Concomitant Administration of Macitentan an… (NCT07147114) | Clinical Trial Compass
RecruitingPhase 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)
South Korea64 participantsStarted 2025-11-24
Plain-language summary
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.
Who can participate
Age range19 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Known hypersensitivity to the active ingredients (Macitentan, Dapagliflozin) or any excipients of the investigational medicinal product
✕
What they're measuring
1
Hierarchical outcome component(Change in PVR, Change in NT-proBNP, Change in 6MWD, Change in KCCQ-CSS)
. 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)
✕. 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