Phase 4 Pulmonary Hypertension Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 19 years or older living in South Korea
• People whose heart pumps out more than 40% of blood per beat, confirmed by a heart ultrasound done within the past 12 weeks
• People diagnosed with a type of heart failure (with mildly reduced or preserved pumping ability) that is also causing raised blood pressure in the lungs (a specific type called combined pre- and post-capillary pulmonary hypertension)
• People whose lung blood pressure measurements from a right heart catheter procedure (a test using a tube inserted into the heart) within the past 48 weeks show all three of the following: average lung artery pressure above 20 mmHg, lung vascular resistance above 2 Wood units, and lung wedge pressure above 15 mmHg
• People rated as WHO Functional Class II or III at screening — meaning their symptoms cause only slight or noticeable limitations during everyday activity
• People who are taking any heart-related medications listed below must have been on a stable dose for at least 3 months before screening: medicines that affect the renin-angiotensin system, beta-blockers, aldosterone blockers, SGLT2 inhibitors, or ivabradine
• People who are still rated as WHO Functional Class II or III at their baseline visit (a second check before the trial starts)

Who may not be able to join:

• People with a known allergy or sensitivity to the trial medicines (Macitentan or Dapagliflozin) or any of their ingredients
• Women who are pregnant or breastfeeding, or people (of any sex) who do not agree to use at least two approved contraceptive methods during the trial and for 30 days after the last dose; male participants who do not agree to avoid donating sperm during this period are also excluded (confirm with trial site for the full list of accepted contraceptive methods)
• People with Type 1 diabetes or diabetes caused by another medical condition
• People with metabolic acidosis, such as diabetic ketoacidosis (a serious complication where the blood becomes too acidic)
• People diagnosed with any type of pulmonary hypertension other than the type caused by heart failure (for example, pulmonary arterial hypertension, lung-disease-related pulmonary hypertension, chronic blood-clot-related pulmonary hypertension, or pulmonary hypertension with unclear causes)
• People whose lung wedge pressure reading from a right heart catheter procedure within the past 12 weeks was 15 mmHg or below
• People who have taken any of the following medicines within the past 4 weeks: calcium channel blockers, endothelin receptor antagonists, PDE5 inhibitors, riociguat, prostacyclin medicines, or activin signalling inhibitors
• People who have had a heart attack, heart bypass surgery, or a coronary artery procedure within the past 3 months
• People with uncontrolled fast heart rate (above 110 beats per minute) due to an irregular heart rhythm (atrial fibrillation or atrial flutter)
• People who have had a heart transplant or a mechanical heart pump device implanted, or who are planning to have either procedure
• People with significantly reduced kidney function (eGFR at or below 30 mL/min/1.73 m²) or significantly elevated liver enzyme levels (AST or ALT at 2.5 times or more above the normal upper limit)
• People who have had a urinary tract infection, genital infection (including fungal infections), or a urinary flow problem within the past 24 weeks
• People with a haemoglobin level below 9 g/dL (indicating significant anaemia) at the time of screening
• People with certain rare inherited conditions affecting how the body processes sugars, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• People with a known allergy or sensitivity to soybean oil, soy, or peanuts
• People who have taken part in another clinical trial involving an investigational medicine or medical device within the past 3 months
• People who are found to have any disqualifying condition when eligibility is re-checked at the baseline visit
• People whom the trial doctor considers unsuitable for any other reason

Important: Always verify eligibility with the trial site directly before applying.