Actively Recruiting
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)
Led by Gachon University Gil Medical Center · Updated on 2026-04-03
64
Participants Needed
15
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults aged 19 years or older in South Korea
- Left ventricular ejection fraction greater than 40% on echocardiogram within 12 weeks prior to screening
- Diagnosis of heart failure with mildly reduced or preserved ejection fraction with combined pre- and post-capillary pulmonary hypertension
- Meeting all of the following on right heart catheterization within 48 weeks prior to screening: mean pulmonary artery pressure over 20 mmHg, pulmonary vascular resistance over 2 Wood units, pulmonary artery wedge pressure over 15 mmHg
- World Health Organization Functional Class II or III at screening and baseline visits
- Stable doses for at least 3 months of any of the following medications if currently taken: renin-angiotensin system inhibitors, beta-blockers, mineralocorticoid receptor antagonists, sodium-glucose cotransporter-2 inhibitors, or Ivabradine
You will not qualify if you...
- Known allergy to Macitentan, Dapagliflozin, or any ingredients in the study drugs
- Pregnant or breastfeeding women or those not agreeing to use two effective contraception methods during and 30 days after the trial (for men, agreeing to avoid sperm donation)
- Diagnosis of type 1 diabetes or secondary diabetes mellitus
- Metabolic acidosis such as diabetic ketoacidosis
- Pulmonary hypertension from causes other than WHO Group 2 (including Groups 1, 3, 4, or 5)
- Pulmonary artery wedge pressure 15 mmHg or less on right heart catheterization within 12 weeks prior to screening
- Use of calcium channel blockers, endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, Riociguat, prostacyclin analogs or receptor agonists, or activin signaling inhibitors within 4 weeks prior to screening
- History of recent (within 3 months) myocardial infarction, coronary bypass surgery, or percutaneous coronary intervention
- Uncontrolled fast heart rate (>110 bpm) due to atrial fibrillation or flutter
- History of heart transplantation or ventricular assist device implantation or planned procedures
- Severe kidney impairment (eGFR ≤ 30 mL/min/1.73 m²) or elevated liver enzymes (AST or ALT ≥ 2.5 times upper limit)
- Recent urinary or genital infections or voiding disorders within 24 weeks prior to screening
- Low hemoglobin (<9 g/dL) at screening
- Genetic disorders like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Allergy to soybean oil, soy, or peanuts
- Participation in another clinical trial within 3 months prior to screening
- Any disqualifying condition identified at baseline visit or judged unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
2
Chungbuk National University Hospital
Chungju, South Korea, 28644
Not Yet Recruiting
3
Keimyung University Dongsan Hospital
Daegu, South Korea, 42601
Actively Recruiting
4
Chungnam National University Hospital
Daejeon, South Korea, 35015
Actively Recruiting
5
Chonnam National University Hospital
Gwangju, South Korea, 61469
Actively Recruiting
6
Incheon Sejong Hospital
Incheon, South Korea, 21080
Not Yet Recruiting
7
Gachon University Gil Hospital
Incheon, South Korea, 405-760
Actively Recruiting
8
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
9
Yonsei University Health System, Severance Hospital
Seoul, South Korea, 03722
Not Yet Recruiting
10
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
11
Samsung Medical Center
Seoul, South Korea, 06351
Not Yet Recruiting
12
The Catholic University of Korea, Seoul St.Mary
Seoul, South Korea, 06591
Actively Recruiting
13
Koera University Guro Hospital
Seoul, South Korea, 08308
Not Yet Recruiting
14
Yonsei University, Wonju Severance Christian Hospital
Wŏnju, South Korea, 26426
Actively Recruiting
15
Pusan National University Yangsan Hospital
Yangsan, South Korea, 50612
Not Yet Recruiting
Research Team
W
Wook-Jin Chung, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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