Phase 2 study to evaluate the efficacy and safety of intermittent levosimendan compared with placebo in hemodynamic improvement with exercise in PH-HFpEF subjects
Levosimendan and its prolonged active metabolite, OR-1896, have been shown to have favorable hemodynamic effects in subjects with pulmonary hypertension and right heart failure. Clinical studies that have been conducted in subjects with right heart failure and pulmonary hypertension suggest levosimendan may be an effective therapy in treatment of subjects with PH-HFpEF. This study will provide demonstration of levosimendan/OR-1896's effectiveness in critical measures of hemodynamic response in weekly administration of levosimendan and the concomitant response as measured by exercise capacity, subject quality of life, and changes in functional capacity. These data will support and guide the Phase 3 development of levosimendan in PH-HFpEF subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
Stanford Healthcare
Stanford, California, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Change From Baseline Pulmonary Capillary Wedge Pressure (PCWP) With Bicycle Exercise
Change from baseline Pulmonary Capillary Wedge Pressure (PCWP) with bicycle exercise at Week 6
Time frame: Baseline, Week 6
Change in Cardiac Index (CI) at Rest and With Exercise.
Change in Cardiac Index (CI) at rest and with exercise at Week 6 (CI determined by thermodilution) (CI is a hemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA))
Time frame: Baseline, Week 6
Change in Pulmonary Vascular Resistance (PVR) Effect at Rest and With Exercise
Change in Pulmonary Vascular Resistance (PVR) effect at rest and with exercise at Week 6
Time frame: Baseline, Week 6
Change in PCWP When Supine and Legs Elevated
Change in Pulmonary Capillary Wedge Pressure, Baseline to Week 6
Time frame: Baseline, Week 6
Patient Global Assessment
Patient assessment of well-being based on 6 questions assessed on a 5-point Likert Scale ( 1 =worst, 5= best) (minimum total score 5pts, maximum total score 25 pts) (no comparison to baseline as no instrument used at baseline)
Time frame: Baseline, Week 6
Exercise Duration Via 6 Minute Walk Test
Change in 6-minute walk test at Week 6 vs baseline
Time frame: Baseline, Week 6
Physician's Assessment of Functional Class
Physician's Assessment of New York Heart Association (NYHA) Classification (one of four categories based on how much the patient is limited during physical activity. (Class I, no limitation of physical activity to Class IV, marked limitation of physical activity).
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Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
North Shore University Hospital
Manhasset, New York, United States
New York Presbyterian Hospital-Weill Cornell Medicine
New York, New York, United States
...and 6 more locations
Time frame: Baseline, Week 6
Number of Participants With Composite Events of Death or Hospitalization
Number of Participants with Composite Events of death or hospitalization through Week 6
Time frame: Baseline, Week 6