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)

Recruiting Phase 4 Interventional Study
Combined Pre- and Post-capillary Pulmonary Hypertension CpcPH HFmrEF HFpEF Group 2 Pulmonary Hypertension
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
19 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
64 (estimated)
Sponsor
Gachon University Gil Medical Center · Other
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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 b…
Trial Locations
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Eligibility Criteria
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 ejecti…
Contacts

Wook-Jin Chung, MD, PhD

82-32-460-3663

heart@gilhospital.com

CONTACT