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Soprano

General Information

Age Group

Adult

Status

Active

Protocol Number

NCT02554903

Background Information

This trial seeks to evaluate the efficacy of Macitentan in patients with pulmonary hypertension after left-ventricular device (LVAD) implantation. 

This study is a US-based, prospective, double-blind, multicenter, placebo-controlled, randomized 1:1, pulmonary hypertension in LVAD patients trial.

Offered At

Inova Heart and Vascular Institute
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Shashank Desai, MD

Eligibility Information

  • 18 years or older
  • LVAD Implantation within last 45 days
  • Evidence of pulmonary hypertension post-LVAD implantation via the following:
    • mPAP ≥ 25mmHg
    • PCWP ≤ 18mmHg
    • PVR > 3 Wood Units

Ineligibility Information

  • Hemoglobin < 8.5mg/dl
  • GFR < 30
  • FEV1 < 50% predicted
  • Participating in another prospective LVAD study (e.g. HeartMate3)

Contact Name

Bhruga Shah
703-776-2995
bhruga.shah@inova.org
or
Vinita Gupta
703-776-3697
vinita.gupta@inova.org

or
Call the main Advanced Heart Failure Research office at 703-776-2828