Phase 2
N=35
Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
Hypertension Pulmonary Secondary Heart Failure · Right Sided Heart Failure With Normal Ejection Fraction · Heart Failure With Normal Ejection Fraction
Bottom Line
View on ClinicalTrials.gov: NCT03624010 ↗Enrolled (actual)
35
Serious AEs
68.6%
Results posted
Apr 2026
Primary outcome: Primary: Clinical Safety — 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Levosimendan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tenax Therapeutics, Inc.
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Safety |
33 | — |
Summary
PH-HFpEF patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
Eligibility Criteria
Inclusion Criteria
- Provide a personally signed and dated informed consent document prior to initiation of any study-related procedures that are not considered standard of care.
- Completed double-blind therapy in a PH-HFpEF clinical study sponsored by Tenax Therapeutics, Inc.
- May, in the opinion of the Investigator, benefit from continued levosimendan treatment.
- Female patients of childbearing potential must agree to use a highly effective method of contraception.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion Criteria
- Discontinued treatment in the parent study for any reason other than study completion or Sponsor termination of the study.
- Pregnant or breastfeeding women.
- Local access to commercially available levosimendan
- Inability to comply with planned study procedures
- Patients with scheduled lung or heart transplant or cardiac surgery
- Dialysis developed since enrollment in parent study (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration)
- Estimated glomerular filtration rate (eGFR) 150kg
- Systolic blood pressure (SBP) cannot be managed to ensure SBP >100 mmHg at initiation of study drug
- Heart rate >100 bpm with study drug, persistent for at least 10 minutes at screening.
- Hemoglobin 5.5 mmol/L at baseline that is unresponsive to management
Data sourced from ClinicalTrials.gov (NCT03624010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.