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)

NCT: NCT07147114 · Status: RECRUITING · Phase: Phase 4 · Sponsor: Gachon University Gil Medical Center · Started: 2025-11-24 · Est. Completion: 2027-09-30

Official 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.

Study Design

Study Type: INTERVENTIONAL
Allocation: RANDOMIZED
Model: PARALLEL
Masking: DOUBLE
Enrollment: 64 participants

Interventions

DRUG: Combination therapy — Macitentan 10mg, Dapagliflozin 10mg or 5mg po tablet q.d. in 24 weeks
DRUG: Monotherapy — Macitentan placebo, Dapagliflozin 10mg or 5mg po tablet q.d. in 24 weeks

Primary Outcomes

Hierarchical outcome component(Change in PVR, Change in NT-proBNP, Change in 6MWD, Change in KCCQ-CSS) (Baseline, 24 week)

Secondary Outcomes

Change in Pulmonary Vascular Resistance (PVR) from Baseline to Week 24 (Baseline, 24 week)
Change in Mean Pulmonary Arterial Pressure (mPAP) from Baseline to Week 24 (Baseline, 24 week)
Change in Pulmonary Arterial Wedge Pressure (PAWP) from Baseline to Week 24 (Baseline, 24 week)
Change in 6-Minute Walk Distance from Baseline to Week 24 (Baseline, 24 week)
Change in Oxygen Saturation (SpO2) Difference Before and After 6-Minute Walk Test from Baseline to Week 24 (Baseline, 24 week)

Trial Locations

Pusan National University Hospital, Busan, South Korea
Chungbuk National University Hospital, Chungju, South Korea
Keimyung University Dongsan Hospital, Daegu, South Korea
Chungnam National University Hospital, Daejeon, South Korea
Chonnam National University Hospital, Gwangju, South Korea
Incheon Sejong Hospital, Incheon, South Korea
Gachon University Gil Hospital, Incheon, South Korea
Seoul National University Hospital, Seoul, South Korea
Yonsei University Health System, Severance Hospital, Seoul, South Korea
Asan Medical Center, Seoul, South Korea
...and 5 more locations