A Multi-center, Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

CompletadoFase 2ClinicalTrials.gov

ID: NCT03153111Tipo: INTERVENTIONALInicio: 11 de jul de 2017Fin estimado: 12 de mar de 2021

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Macitentan

macitentan 10 mg; film-coated tablet; oral use

drug

Placebo

film-coated tablet (identical to the macitentan tablet); oral use

Ubicaciones

Centro Médico Dra. De Salvo

Buenos Aires, Argentina

CCBR - Buenos Aires - AR

Buenos Aires, Argentina

Clinica Adventista Belgrano

CABA, Argentina

Instituto de Investigaciones Clinicas Mar del Plata

Mar del Plata, Argentina

Patrocinadores

PrincipalActelion

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Multi-center, Double-blind, Placebo-controlled Phase 2b... | EligiMed