SERENADE

Condition: Heart failure, pulmonary vascular disease

Eligibility

Key Inclusion Criteria

  • At least 18 years old
  • Signs or symptoms of heart failure requiring treatment with at least one oral diuretic
  • Left ventricular ejection fraction (LVEF) ≥40%

Key Exclusion Criteria

  • Any prior measurement of LVEF <40%
  • Significant, unrepaired structural valvular heart disease
  • Hypertrophic, restrictive and infiltrative cardiomyopathies

Full Study Name

Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease (IRB no. 49801)

Summary

While several drugs are available to manage heart failure symptoms, no treatment has been approved specifically for left heart failure with preserved ejection fraction and pulmonary vascular disease. The purpose of the study is to determine the safety and effectiveness of a drug called macitentan in patients with this condition.

Macitentan may reduce unwanted effects of a chemical substance in the body called endothelin, which has been detected in increased amounts in patients with heart failure. By blocking the action of endothelin, macitentan lowers the blood pressure in the pulmonary arteries and may slow down overgrowth of the heart muscle. Participants will be randomly assigned to one of two treatment groups: Group 1 will take their usual heart failure medications in addition to the study drug, macitentan; Group 2 will take their usual heart failure medications in addition to placebo (inactive substance).

Macitentan 10 mg has been approved for the treatment of patients with pulmonary arterial hypertension but has not been approved by the U.S. Food and Drug Administration (FDA) for heart failure and pulmonary vascular disease.

Phase

Phase II-III

Principal Investigator

Antoine Hage, MD

Contact
Savannah Mersola
Phone: 310-248-7107
Email: savannah.mersola@csmns.org