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Tests treatment safety and results for Combined Pre- and Post-capillary Pulmonary Hypertension
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)
ClinicalTrials.gov ID: NCT07147114
What this study is testing
What is Combination therapy?
Combination therapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for combined pre- and post-capillary pulmonary hypertension.
Also referred to as Maciten Tab. 10mg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 24 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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...
- Meeting all of the following criteria on RHC performed within 48 weeks prior to screening:
- mPAP \> 20 mmHg
You likely can't join if
- 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...
- Participants with type 1 diabetes mellitus or secondary diabetes mellitus
- Participants with metabolic acidosis, such as diabetic ketoacidosis
- 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
See the full eligibility criteria
- 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
- 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 \ 1\. World Health Organization Functional Class (WHO-FC) II or III at the time of baseline visit
- 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...
- Participants with type 1 diabetes mellitus or secondary diabetes mellitus
- Participants with metabolic acidosis, such as diabetic ketoacidosis
- 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: a. 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 \
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Busan, South Korea
- Chungju, South Korea
- Daegu, South Korea
- Daejeon, South Korea
- Gwangju, South Korea
- Incheon, South Korea
- Seoul, South Korea
- Wŏnju, South Korea
- Yangsan, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Busan, South Korea; Chungju, South Korea; Daegu, South Korea; Daejeon, South Korea; Gwangju, South Korea; Incheon, South Korea and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.