A Phase 4 interventional study of Combination therapy and Monotherapy in Combined Pre- and Post-capillary Pulmonary Hypertension, CpcPH and HFmrEF, sponsored by Gachon University Gil Medical Center. Recruiting at 15 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Gachon University Gil Medical Center · Phase 4, Interventional, and Treatment
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.
1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.
This study's planned enrollment of 64 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Gachon University Gil Medical Center is the lead sponsor of 90 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
\<Screening Visit (Visit 1)>
Meeting all of the following criteria on RHC performed within 48 weeks prior to screening:
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:
\<Baseline Visit (Visit 2)>
1. World Health Organization Functional Class (WHO-FC) II or III at the time of baseline visit
Exclusion Criteria:
\<Screening Visit (Visit 1)>
Pregnant or breastfeeding women, or those who do not agree to use at least two appropriate 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.
Participants diagnosed with pulmonary hypertension other than WHO Group 2 pulmonary hypertension (i.e., WHO Group 1, 3, 4, or 5)
Participants who meet the following criteria on RHC performed within 12 weeks prior to screening:
a. PAWP ≤ 15 mmHg
History of taking any of the following medications within 4 weeks prior to screening:
History of any of the following medical conditions, surgeries, or procedures:
\<Baseline Visit (Visit 2)>
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Maciten Tab. 10mg
Drug: Combination therapy
Dapozin Tab. 10mg or 5mg
Drug: Monotherapy
Macitentan 10mg, Dapagliflozin 10mg or 5mg po tablet q.d. in 24 weeks
Also known as: Maciten Tab. 10mg
Macitentan placebo, Dapagliflozin 10mg or 5mg po tablet q.d. in 24 weeks
Also known as: Dapozin Tab. 10mg or 5mg
Hierarchical outcome component(Change in PVR, Change in NT-proBNP, Change in 6MWD, Change in KCCQ-CSS)
The hierarchical composite variable includes the rate of change in Pulmonary Vascular Resistance (PVR), NT-proBNP, change in 6-minute walk distance, and change in KCCQ-CSS score. All possible pairwise comparisons between combination therapy group and monotherapy group subjects (e.g., 2 subjects in combination group and 3 in monotherapy group yield 6 pairs) are classified as Win, Loss, or Tie based on the following definitions. If the subject in the pair meeting the criteria belongs to the combination group, it is evaluated as a Win; if in the monotherapy group, a Loss.
Time frame: Baseline, 24 week
Change in Pulmonary Vascular Resistance (PVR) from Baseline to Week 24
PVR (Wood Units, WU) is measured by Right Heart Catheterization (RHC).
Time frame: Baseline, 24 week
Change in Mean Pulmonary Arterial Pressure (mPAP) from Baseline to Week 24
mPAP (mmHg) is measured by RHC.
Time frame: Baseline, 24 week
Change in Pulmonary Arterial Wedge Pressure (PAWP) from Baseline to Week 24
PAWP (mmHg) is measured by RHC.
Time frame: Baseline, 24 week
Change in 6-Minute Walk Distance from Baseline to Week 24
Distance (meters) measured by 6-minute walk test.
Time frame: Baseline, 24 week
Change in Oxygen Saturation (SpO2) Difference Before and After 6-Minute Walk Test from Baseline to Week 24
Oxygen saturation (%) difference before and after the 6-minute walk test.
Time frame: Baseline, 24 week
Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from Baseline to Week 24
NT-proBNP (pg/mL) measured by clinical laboratory tests.
Time frame: Baseline, 24 week
Change in Tricuspid Regurgitation Velocity (TRV) from Baseline to Week 24
TRV (m/s) measured by echocardiography.
Time frame: Baseline, 24 week
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) from Baseline to Week 24
TAPSE (mm) measured by echocardiography.
Time frame: Baseline, 24 week
Use of Intravenous Diuretics During Treatment Period (Visit 2 to Visit 4)
The number of intravenous diuretic administrations collected via concomitant medication records.
Time frame: Baseline, 24 week
Rate of Hospitalization Due to Heart Failure During Treatment Period (Visit 2 to Visit 4)
Number of hospitalizations for heart failure compared between groups during treatment period.
Time frame: Baseline, 24 week
Number of Days Hospitalized for Heart Failure During Treatment Period (Visit 2 to Visit 4)
Total days of hospitalization for heart failure compared between groups during treatment.
Time frame: Baseline, 24 week
Number of Deaths (Cardiovascular and All-Cause) During Treatment Period (Visit 2 to Visit 4)
Cardiovascular and all-cause mortality events compared between groups.
Time frame: Baseline, 24 week
Change in Mean Right Atrial Pressure (mRAP) from Baseline to Week 24
mRAP (mmHg) measured by RHC.
Time frame: Baseline, 24 week
Change in Cardiac Index (CI) from Baseline to Week 24
Cardiac Index (L/min/m²) measured by RHC.
Time frame: Baseline, 24 week
Change in Mixed Venous Oxygen Saturation (SvO2) from Baseline to Week 24
SvO2 (%) measured by RHC.
Time frame: Baseline, 24 week
Change in Left Atrial Volume Index (LAVI) from Baseline to Week 24
LAVI (mL/m²) measured by echocardiography and body measurements.
Time frame: Baseline, 24 week
Change in Tricuspid Valve Systolic Tissue Velocity (TV S' velocity) from Baseline to Week 24
TV S' velocity (cm/s) measured by echocardiography.
Time frame: Baseline, 24 week
Change in Right Atrial Area (RA area) from Baseline to Week 24
RA area (cm²) measured by echocardiography.
Time frame: Baseline, 24 week
Change in Presence of Pericardial Effusion from Baseline to Week 24
Presence or absence of pericardial effusion evaluated by echocardiography.
Time frame: Baseline, 24 week
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) from Baseline to Week 24
KCCQ-OSS measured by questionnaire.
Time frame: Baseline, 24 week
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gachon University Gil Medical Center