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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)

NCT07147114•Gachon University Gil Medical Center

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\<Screening Visit (Visit 1)\>
•1. A male or female adults aged 19 years or older in South Korea
•2. LVEF greater than 40% on echocardiogram performed within 12 weeks prior to screening
•3. 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)
•4. Meeting all of the following criteria on RHC performed within 48 weeks prior to screening:
•1. mPAP \> 20 mmHg
•2. PVR \> 2 Wood units (WU)
•3. PAWP \> 15 mmHg
•5. World Health Organization Functional Class (WHO-FC) II or III at the time of screening
•6. 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:
+7 more criteria

Exclusion Criteria

•\<Screening Visit (Visit 1)\>
•1. Known hypersensitivity to the active ingredients (Macitentan, Dapagliflozin) or any excipients of the investigational medicinal product
•2. 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.
•3. Participants with type 1 diabetes mellitus or secondary diabetes mellitus
•4. Participants with metabolic acidosis, such as diabetic ketoacidosis
•5. Participants diagnosed with pulmonary hypertension other than WHO Group 2 pulmonary hypertension (i.e., WHO Group 1, 3, 4, or 5)
•1. Group 1: Pulmonary arterial hypertension
•2. Group 3: Pulmonary hypertension associated with lung diseases and/or hypoxia
•3. Group 4: Chronic thrombo-embolic pulmonary hypertension
+23 more criteria

Locations (15)

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

Key Dates

Start Date

October 31, 2025

Primary Completion Date

September 30, 2027

Completion Date

September 30, 2027

Last Updated

September 5, 2025

Enrollment

ESTIMATED participants

Conditions

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

Interventions

Combination therapy

DRUG

Monotherapy

DRUG

Contacts

Wook-Jin Chung, MD, PhD

CONTACT

82-32-460-3663 heart@gilhospital.com