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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

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)

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) is a Phase 4 interventional studying Combined Pre- and Post-capillary Pulmonary Hypertension and CpcPH, sponsored by Gachon University Gil Medical Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 64 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Combined Pre- and Post-capillary Pulmonary Hypertension subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: \<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: 1. Renin-angiotensin system inhibitors 2. Beta-blockers 3. Mineralocorticoid receptor antagonists (aldosterone antagonists) 4. Sodium-glucose cotransporter-2 (SGLT2) inhibitors 5. Ivabradine \<Baseline Visit (Visit 2)\> 1\. World Health Organization Functional Class (WHO-FC) II or III at the time of baseline visit Who Should NOT Join This Trial: \<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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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: 1. Renin-angiotensin system inhibitors 2. Beta-blockers 3. Mineralocorticoid receptor antagonists (aldosterone antagonists) 4. Sodium-glucose cotransporter-2 (SGLT2) inhibitors 5. Ivabradine \<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)\> 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 4. Group 5: Pulmonary hypertension with unclear and/or multifactorial mechanisms 6. Participants who meet the following criteria on RHC performed within 12 weeks prior to screening: a. PAWP ≤ 15 mmHg 7. History of taking any of the following medications within 4 weeks prior to screening: 1. Calcium channel blockers 2. Endothelin receptor antagonists 3. Phosphodiesterase type 5 inhibitors (PDE5i) 4. Riociguat 5. Prostacyclin (PC) analogs or prostacyclin receptor agonists 6. Activin signaling inhibitors 8. History of any of the following medical conditions, surgeries, or procedures: 1. Myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention (PCI) within 3 months prior to screening 2. Uncontrolled tachycardia (\>110 bpm) due to atrial fibrillation or atrial flutter 3. History of heart transplantation or implantation of a ventricular assist device, or planned to undergo such procedures 9. eGFR ≤ 30 mL/min/1.73 m² or AST or ALT ≥ 2.5 × ULN 10. Urinary tract infection, genital infection (including fungal infections), or voiding disorder within 24 weeks prior to screening 11. Hemoglobin \< 9 g/dL at the time of screening 12. Participants with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 13. Known hypersensitivity to soybean oil or history of soybean oil allergy 14. Known hypersensitivity to soy or peanuts 15. 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)\> 1. Participants who, upon re-confirmation of inclusion/exclusion criteria at the baseline visit, have any disqualifying condition 2. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this clinical trial

Treatments Being Tested

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

Locations (15)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea, Seoul St.Mary
Seoul, South Korea
Koera University Guro Hospital
Seoul, South Korea
Yonsei University, Wonju Severance Christian Hospital
Wŏnju, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07147114), the sponsor (Gachon University Gil Medical Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07147114 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07147114?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07147114?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07147114. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07147114. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.