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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)

ConditionsCombined Pre- and Post-capillary Pulmonary HypertensionCpcPHHFmrEFHFpEFGroup 2 Pulmonary Hypertension
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorGachon University Gil Medical Center

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

mPAP > 20 mmHg

Disqualifiers

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 investigational medicinal product (for male participants, those who do not agree to refrain from sperm donation)

Participants with type 1 diabetes mellitus or secondary diabetes mellitus

Participants with metabolic acidosis, such as diabetic ketoacidosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Combination therapy

    Drug

    Macitentan 10mg, Dapagliflozin 10mg or 5mg po tablet q.d. in 24 weeks

  • Monotherapy

    Drug

    Macitentan placebo, Dapagliflozin 10mg or 5mg po tablet q.d. in 24 weeks

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Combination therapy groupExperimental treatment 1 intervention
Group B: Monotherapy groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hierarchical outcome component(Change in PVR, Change in NT-proBNP, Change in 6MWD, Change in KCCQ-CSS)

The hierarchical composite variable includes the rate of change in Pulmonary Vascular Resistance (PVR), NT-proBNP, change in 6-minute walk distance, and change in KCCQ-CSS score. All possible pairwise comparisons between combination therapy group and monotherapy group subjects (e.g., 2 subjects in combination group and 3 in monotherapy group yield 6 pairs) are classified as Win, Loss, or Tie based on the following definitions. If the subject in the pair meeting the criteria belongs to the combination group, it is evaluated as a Win; if in the monotherapy group, a Loss.

Time frame
Baseline, 24 week

Secondary outcomes

1

Change in Pulmonary Vascular Resistance (PVR) from Baseline to Week 24

PVR (Wood Units, WU) is measured by Right Heart Catheterization (RHC).

Time frame
Baseline, 24 week
2

Change in Mean Pulmonary Arterial Pressure (mPAP) from Baseline to Week 24

mPAP (mmHg) is measured by RHC.

Time frame
Baseline, 24 week
3

Change in Pulmonary Arterial Wedge Pressure (PAWP) from Baseline to Week 24

PAWP (mmHg) is measured by RHC.

Time frame
Baseline, 24 week
4

Change in 6-Minute Walk Distance from Baseline to Week 24

Distance (meters) measured by 6-minute walk test.

Time frame
Baseline, 24 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gachon University Gil Medical Center

Lead sponsor

Source ClinicalTrials.gov
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