A Long Term Study to Find Out if Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

Phase 2 Terminated 91 enrolled Actelion AcitGraph · collab Almac Clinical Technologies · collab Chiltern International Inc. · collab Covance · collab Frontier Science & Technology Research Foundation, Inc. · collab Medidata Solutions · collab WorldCare Clinical, LLC · collab

NaSingle-groupOpen-labelTreatment

Summary

The aim of this open-label (OL) extension trial is to study the long-term safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease (PVD) beyond the treatment in the double-blind parent SERENADE study (AC-055G202, NCT03153111). Furthermore, this OL extension study will give eligible subjects of the main study (SERENADE/AC-055G202, NCT03153111) an opportunity to continue or start receiving macitentan.

Timeline

Start: 2018-12-07
Primary completion: 2021-10-12
Completion: 2021-10-12

Publications

Shah SJ, Bonderman D, Borlaug BA, Cleland JGF, Lack G, Lu W, Voors AA, Zannad F, Gladwin MT. Macitentan for Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Pulmonary Vascular Disease: Results of the SERENADE Randomized Clinical Trial and Open-Label Extension Study. Circ Heart Fail. 2025 Mar;18(3):e011381. doi: 10.1161/CIRCHEARTFAILURE.123.011381. Epub 2025 Mar 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Macitentan	Other / unclassified	10 mg	Oral

A Long Term Study to Find Out if Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

Summary

Timeline

Publications

Drugs

Indications