Combined Pre- and Post-capillary Pulmonary HypertensionPhase 4NCT07147114
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 Phase 4 study testing Combination therapy and Monotherapy in people with Combined Pre- and Post-capillary Pulmonary Hypertension and CpcPH, run by Gachon University Gil Medical Center at 15 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Combined Pre- and Post-capillary Pulmonary Hypertension, CpcPH, HFmrEF
- What is being tested?
- Combination therapy and Monotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 15 sitesSouth Korea
- Study dates
- 24 Nov 2025to 30 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- <Screening Visit (Visit 1)>
- A male or female adults aged 19 years or older in South Korea
- LVEF greater than 40% on echocardiogram performed within 12 weeks prior to screening
- 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)
- Meeting all of the following criteria on RHC performed within 48 weeks prior to screening:
- mPAP > 20 mmHg
Show all 17Show fewer
- PVR > 2 Wood units (WU)
- PAWP > 15 mmHg
- World Health Organization Functional Class (WHO-FC) II or III at the time of 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:
- Renin-angiotensin system inhibitors
- Beta-blockers
- Mineralocorticoid receptor antagonists (aldosterone antagonists)
- Sodium-glucose cotransporter-2 (SGLT2) inhibitors
- Ivabradine
- <Baseline Visit (Visit 2)>
- 1. World Health Organization Functional Class (WHO-FC) II or III at the time of baseline visit
Who cannot join
- <Screening Visit (Visit 1)>
- Known hypersensitivity to the active ingredients (Macitentan, Dapagliflozin) or any excipients of the investigational medicinal product
- 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.
- Participants with type 1 diabetes mellitus or secondary diabetes mellitus
- Participants with metabolic acidosis, such as diabetic ketoacidosis
Show all 34Show fewer
- Participants diagnosed with pulmonary hypertension other than WHO Group 2 pulmonary hypertension (i.e., WHO Group 1, 3, 4, or 5)
- Group 1: Pulmonary arterial hypertension
- Group 3: Pulmonary hypertension associated with lung diseases and/or hypoxia
- Group 4: Chronic thrombo-embolic pulmonary hypertension
- Group 5: Pulmonary hypertension with unclear and/or multifactorial mechanisms
- Participants who meet the following criteria on RHC performed within 12 weeks prior to screening:
- PAWP ≤ 15 mmHg
- History of taking any of the following medications within 4 weeks prior to screening:
- Calcium channel blockers
- Endothelin receptor antagonists
- Phosphodiesterase type 5 inhibitors (PDE5i)
- Riociguat
- Prostacyclin (PC) analogs or prostacyclin receptor agonists
- Activin signaling inhibitors
- History of any of the following medical conditions, surgeries, or procedures:
- Myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention (PCI) within 3 months prior to screening
- Uncontrolled tachycardia (>110 bpm) due to atrial fibrillation or atrial flutter
- History of heart transplantation or implantation of a ventricular assist device, or planned to undergo such procedures
- eGFR ≤ 30 mL/min/1.73 m² or AST or ALT ≥ 2.5 × ULN
- Urinary tract infection, genital infection (including fungal infections), or voiding disorder within 24 weeks prior to screening
- Hemoglobin < 9 g/dL at the time of screening
- Participants with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Known hypersensitivity to soybean oil or history of soybean oil allergy
- Known hypersensitivity to soy or peanuts
- Participation in another clinical trial involving administration/application of an investigational medicinal product or medical device within 3 months prior to screening
- <Baseline Visit (Visit 2)>
- Participants who, upon re-confirmation of inclusion/exclusion criteria at the baseline visit, have any disqualifying condition
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this clinical trial
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
South Korea15 sites, 15 recruiting
- Recruiting
Pusan National University Hospital
Busan, 49241
- Not yet recruiting
Chungbuk National University Hospital
Chungju, 28644
- Recruiting
Keimyung University Dongsan Hospital
Daegu, 42601
- Recruiting
Chungnam National University Hospital
Daejeon, 35015
- Recruiting
Chonnam National University Hospital
Gwangju, 61469
- Not yet recruiting
Incheon Sejong Hospital
Incheon, 21080
- Recruiting
Gachon University Gil Hospital
Incheon, 405-760
Wook-Jin Chung, MD,PhD, 82-32-460-3663, heart@gilhospital.com
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Not yet recruiting
Yonsei University Health System, Severance Hospital
Seoul, 03722
- Recruiting
Asan Medical Center
Seoul, 05505
- Not yet recruiting
Samsung Medical Center
Seoul, 06351
- Recruiting
The Catholic University of Korea, Seoul St.Mary
Seoul, 06591
- Not yet recruiting
Koera University Guro Hospital
Seoul, 08308
- Recruiting
Yonsei University, Wonju Severance Christian Hospital
Wŏnju, 26426
- Not yet recruiting
Pusan National University Yangsan Hospital
Yangsan, 50612
About this study
Official title: 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)
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
- Being tested
- Combination therapy, Monotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination therapyDrug
Also called Maciten Tab. 10mg
Macitentan 10mg, Dapagliflozin 10mg or 5mg po tablet q.d. in 24 weeks
MonotherapyDrug
Also called Dapozin Tab. 10mg or 5mg
Macitentan placebo, Dapagliflozin 10mg or 5mg po tablet q.d. in 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy group | Experimental | Maciten Tab. 10mg Receives: Drug: Combination therapy |
| Monotherapy group | Placebo comparator | Dapozin Tab. 10mg or 5mg Receives: Drug: Monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 24 week
Secondary outcomes (20)
Change in Pulmonary Vascular Resistance (PVR) from Baseline to Week 24
PVR (Wood Units, WU) is measured by Right Heart Catheterization (RHC).
Measured: Baseline, 24 week
Change in Mean Pulmonary Arterial Pressure (mPAP) from Baseline to Week 24
mPAP (mmHg) is measured by RHC.
Measured: Baseline, 24 week
Change in Pulmonary Arterial Wedge Pressure (PAWP) from Baseline to Week 24
PAWP (mmHg) is measured by RHC.
Measured: Baseline, 24 week
Change in 6-Minute Walk Distance from Baseline to Week 24
Distance (meters) measured by 6-minute walk test.
Measured: 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.
Measured: 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.
Measured: Baseline, 24 week
Change in Tricuspid Regurgitation Velocity (TRV) from Baseline to Week 24
TRV (m/s) measured by echocardiography.
Measured: Baseline, 24 week
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) from Baseline to Week 24
TAPSE (mm) measured by echocardiography.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 24 week
Change in Mean Right Atrial Pressure (mRAP) from Baseline to Week 24
mRAP (mmHg) measured by RHC.
Measured: Baseline, 24 week
Change in Cardiac Index (CI) from Baseline to Week 24
Cardiac Index (L/min/m²) measured by RHC.
Measured: Baseline, 24 week
Change in Mixed Venous Oxygen Saturation (SvO2) from Baseline to Week 24
SvO2 (%) measured by RHC.
Measured: Baseline, 24 week
Change in Left Atrial Volume Index (LAVI) from Baseline to Week 24
LAVI (mL/m²) measured by echocardiography and body measurements.
Measured: 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.
Measured: Baseline, 24 week
Change in Right Atrial Area (RA area) from Baseline to Week 24
RA area (cm²) measured by echocardiography.
Measured: Baseline, 24 week
Change in Presence of Pericardial Effusion from Baseline to Week 24
Presence or absence of pericardial effusion evaluated by echocardiography.
Measured: Baseline, 24 week
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) from Baseline to Week 24
KCCQ-OSS measured by questionnaire.
Measured: Baseline, 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start24 Nov 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combined Pre- and Post-capillary Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wook-Jin Chung, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147114
- Sponsor's protocol ID
- MD-CpcPH
- Status last verified
- Mar 2026
- First submitted
- 21 Aug 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07147114
- Acronym / sponsor ID
- MD-CpcPH
- Conditions
- Combined Pre- and Post-capillary Pulmonary Hypertension, CpcPH, HFmrEF, HFpEF, Group 2 Pulmonary Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination therapy group | Experimental | Drug: Combination therapyMaciten Tab. 10mg |
| Monotherapy group | Placebo comparator | Drug: MonotherapyDapozin Tab. 10mg or 5mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- <Screening Visit (Visit 1)>
- A male or female adults aged 19 years or older in South Korea
- LVEF greater than 40% on echocardiogram performed within 12 weeks prior to screening
- 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)
- Meeting all of the following criteria on RHC performed within 48 weeks prior to screening:
Key exclusion criteria (34 listed)
- <Screening Visit (Visit 1)>
- Known hypersensitivity to the active ingredients (Macitentan, Dapagliflozin) or any excipients of the investigational medicinal product
- 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.
- Participants with type 1 diabetes mellitus or secondary diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination therapyAlso: Maciten Tab. 10mgMacitentan 10mg, Dapagliflozin 10mg or 5mg po tablet q.d. in 24 weeks | Drug | Combination therapy group |
| MonotherapyAlso: Dapozin Tab. 10mg or 5mgMacitentan placebo, Dapagliflozin 10mg or 5mg po tablet q.d. in 24 weeks | Drug | Monotherapy group |
Primary outcome
Hierarchical outcome component(Change in PVR, Change in NT-proBNP, Change in 6MWD, Change in KCCQ-CSS)
Time frame: Baseline, 24 week
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.
20 secondary outcomes
Change in Pulmonary Vascular Resistance (PVR) from Baseline to Week 24
Time frame: Baseline, 24 week
Change in Mean Pulmonary Arterial Pressure (mPAP) from Baseline to Week 24
Time frame: Baseline, 24 week
Change in Pulmonary Arterial Wedge Pressure (PAWP) from Baseline to Week 24
Time frame: Baseline, 24 week
Change in 6-Minute Walk Distance from Baseline to Week 24
Time frame: Baseline, 24 week
Change in Oxygen Saturation (SpO2) Difference Before and After 6-Minute Walk Test from Baseline to Week 24
Time frame: Baseline, 24 week
Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from Baseline to Week 24
Time frame: Baseline, 24 week
Change in Tricuspid Regurgitation Velocity (TRV) from Baseline to Week 24
Time frame: Baseline, 24 week
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) from Baseline to Week 24
Time frame: Baseline, 24 week
Use of Intravenous Diuretics During Treatment Period (Visit 2 to Visit 4)
Time frame: Baseline, 24 week
Rate of Hospitalization Due to Heart Failure During Treatment Period (Visit 2 to Visit 4)
Time frame: Baseline, 24 week
Number of Days Hospitalized for Heart Failure During Treatment Period (Visit 2 to Visit 4)
Time frame: Baseline, 24 week
Number of Deaths (Cardiovascular and All-Cause) During Treatment Period (Visit 2 to Visit 4)
Time frame: Baseline, 24 week
Change in Mean Right Atrial Pressure (mRAP) from Baseline to Week 24
Time frame: Baseline, 24 week
Change in Cardiac Index (CI) from Baseline to Week 24
Time frame: Baseline, 24 week
Change in Mixed Venous Oxygen Saturation (SvO2) from Baseline to Week 24
Time frame: Baseline, 24 week
Change in Left Atrial Volume Index (LAVI) from Baseline to Week 24
Time frame: Baseline, 24 week
Change in Tricuspid Valve Systolic Tissue Velocity (TV S' velocity) from Baseline to Week 24
Time frame: Baseline, 24 week
Change in Right Atrial Area (RA area) from Baseline to Week 24
Time frame: Baseline, 24 week
Change in Presence of Pericardial Effusion from Baseline to Week 24
Time frame: Baseline, 24 week
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) from Baseline to Week 24
Time frame: Baseline, 24 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combination therapy and Monotherapy in people with Combined Pre- and Post-capillary Pulmonary Hypertension and CpcPH, run by Gachon University Gil Medical Center at 15 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wook-Jin Chung, MD, PhD (82-32-460-3663, heart@gilhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical outcome component(Change in PVR, Change in NT-proBNP, Change in 6MWD, Change in KCCQ-CSS) (time frame: Baseline, 24 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.