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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 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-04-03

No results posted yet for this study

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).

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

Interventions

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

Sponsors & Collaborators

  • Gachon University Gil Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-24
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07147114 on ClinicalTrials.gov