Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients

Completed · Phase 2

Conditions studied: Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction, Heart Failure With Normal Ejection Fraction

In brief

PH-HFpEF patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.

Key facts

Study ID

NCT03624010

Run by

Tenax Therapeutics, Inc.

People needed

35

Starts

2019-04-09

Expected to finish

2023-04-25

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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) <30 mL/min/1.73m2
• Liver dysfunction with Child Pugh Class B or C (see Attachment 2)
• Evidence of systemic bacterial, systemic fungal, or viral infection refractory to treatment
• Weight >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 < 80 g/L
• Serum potassium < 3.0 mmol/L or > 5.5 mmol/L at baseline that is unresponsive to management

Where it is running

• Stanford Healthcare — Stanford, California, United States
• Northwestern Memorial Hospital — Chicago, Illinois, 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
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• UPMC Presbyterian Hospital — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• UW Health University Hospital — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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