Trials / Completed
CompletedNCT03624010
Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
Open-Label Rollover Study of Levosimendan in Patients With Pulmonary Hypertension With Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Tenax Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
PH-HFpEF patients will receive weekly open-label doses of levosimendan and be periodically evaluated for safety and effectiveness in extended use.
Detailed description
This study will enroll PH-HFpEF patients that have completed a controlled levosimendan study. These patients will receive weekly open-label doses of levosimendan and be periodically evaluated for safety and effectiveness in extended use.
Conditions
- Hypertension Pulmonary Secondary Heart Failure
- Right Sided Heart Failure With Normal Ejection Fraction
- Heart Failure With Normal Ejection Fraction
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levosimendan 2.5 mg/ml Injectable Solution | 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 |
Timeline
- Start date
- 2018-11-14
- Primary completion
- 2024-02-01
- Completion
- 2024-02-01
- First posted
- 2018-08-09
- Last updated
- 2025-08-27
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03624010. Inclusion in this directory is not an endorsement.