A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
Condition: Heart Failure With Preserved Ejection Fraction
MeSH terms: Heart Failure; Vascular Diseases
Intervention: Macitentan; Placebo
Intervention description: macitentan 10 mg; film-coated tablet; oral use; film-coated tablet (identical to the macitentan tablet); oral use
Intervention MeSH terms: Macitentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate whether macitentan is an effective and safe treatment for
      patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular
      disease.

      The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain
      natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signs or symptoms of Heart Failure (HF) (NYHA FC I I and II I ) requiring treatment
             with at least one oral diuretic (any type)

          -  Left ventricular ejection fraction (LVEF) ≥ 40% (by echocardiography at Screening)

          -  Structural heart disease consistent with heart failure with preserved ejection
             fraction (HFpEF) established by echocardiography at Screening

          -  Elevated NT-proBNP

          -  Pulmonary vascular disease or right ventricular dysfunction

        Exclusion Criteria:

          -  Any prior valid measurement of LVEF < 40%. An echocardiogram is considered valid if
             its quality is sufficient to allow accurate assessment of LVEF and if it is reflective
             of the true status of the subject

          -  Cardiovascular co-morbidities (e.g., significant unrepaired structural valvular heart
             disease; acute coronary syndrome, coronary artery bypass graft (CABG) or percutaneous
             coronary intervention (PCI) within 3 months of Screening; uncontrolled heart rate from
             atrial fibrillation or atrial flutter, history of serious life-threatening or
             hemodynamically significant arrhythmia; history of or anticipated heart transplant or
             ventricular assist device implantation, etc)

          -  Systolic blood pressure (SBP) ≥ 180 mmHg, or diastolic blood pressure (DBP) ≥ 110 mmHg
             during Screening

          -  Hemoglobin < 100g/L (< 10 g/dl) at Screening

          -  Significant parenchymal lung disease (e.g., severe COPD, moderate or severe
             restrictive lung disease, diffuse interstitial fibrosis or alveolitis, pulmonary
             thromboembolism)

          -  Severe renal dysfunction with an estimated Glomerular Filtration Rate (eGFR) < 30
             mL/min per 1.73 m2

          -  Severe hepatic impairment, e.g., Child Pugh Class C

        Other protocol-defined inclusion/exclusion criteria may apply