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)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Gachon University Gil Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Combined Pre- and Post-capillary Pulmonary Hypertension
• CpcPH
• HFmrEF
• HFpEF
• Group 2 Pulmonary Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-24
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2025-08-28
• Last updated: 2026-04-03

Locations

15 sites across 1 country: South Korea