NCT07147114View on ClinicalTrials.gov

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)

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions
Combined Pre- and Post-capillary Pulmonary HypertensionCpcPHHFmrEFHFpEFGroup 2 Pulmonary Hypertension
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

Trial Locations (15)

21080

Incheon Sejong Hospital, Incheon

26426

Yonsei University, Wonju Severance Christian Hospital, Wŏnju

28644

Chungbuk National University Hospital, Chungju

35015

Chungnam National University Hospital, Daejeon

42601

Keimyung University Dongsan Hospital, Daegu

49241

Pusan National University Hospital, Busan

50612

Pusan National University Yangsan Hospital, Yangsan

61469

Chonnam National University Hospital, Gwangju

405-760

Gachon University Gil Hospital, Incheon

03080

Seoul National University Hospital, Seoul

03722

Yonsei University Health System, Severance Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea, Seoul St.Mary, Seoul

08308

Koera University Guro Hospital, Seoul

All Listed Sponsors
lead

Gachon University Gil Medical Center

OTHER