Trials / Completed
CompletedNCT03541603
Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF
A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Tenax Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase 2 study to evaluate the efficacy and safety of intermittent levosimendan compared with placebo in hemodynamic improvement with exercise in PH-HFpEF subjects
Detailed description
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.
Conditions
- Hypertension Pulmonary Secondary
- Heart Failure, Right Sided
- Heart Failure With Normal Ejection Fraction
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levosimendan | 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 |
| DRUG | Matching Placebo | 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 |
Timeline
- Start date
- 2018-11-14
- Primary completion
- 2020-04-07
- Completion
- 2020-04-07
- First posted
- 2018-05-30
- Last updated
- 2024-11-20
- Results posted
- 2024-05-14
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03541603. Inclusion in this directory is not an endorsement.