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

Phase 1

• Conditions: Heart failure with preserved ejection fraction and pulmonary vascular disease; MedDRA version: 20.1Level: LLTClassification code 10076396Term: Heart failure with preserved ejection fractionSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003653-15-DE
• Lead Sponsor: ACTELION Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-09
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• Signs or symptoms of Heart Failure (HF) (NYHA FC II and III) 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 129

Exclusion Criteria

• Any prior valid measurement of LVEF < 40%.
• 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).
• 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 m L/min per 1.73 m2
• Severe hepatic impairment, e .g., Child Pugh Class C.

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified