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

NCT03624010 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TNX-LVO-05
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Hypertension Pulmonary Secondary Heart Failure; Right Sided Heart Failure With Normal Ejection Fraction; Heart Failure With Normal Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Clinical Safety

  Number of Adverse Events per Patient Population

  Duration of study (for up to 2 years); Assessed at Weeks 3, 6, 12, 24, and 48 and Follow-Up Visit (termination visit).

Study Arms (1)

Levosimendan Open-Label

OTHER

Initial: 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. Ongoing patients are transitioned to daily oral levosimendan (1mg capsules TID)

Drug: Levosimendan

Interventions

Levosimendan DRUG

Initial: 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 a weekly 24 hour infusion. Transioned to: Daily Levosimendan capsules (1 mg TID)

Levosimendan Open-Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Tenax Therapeutics, Inc.: lead
• Medpace, Inc.: collaborator

Study Sites (9)

Stanford Healthcare

Stanford, California, 94305, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

UW Health University Hospital

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Simendan

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

This was an uncontrolled observational study of patients transitioning from a controlled study to open-label levosimendan. After an average of 11.5 months on study, ongoing patients were transitioned from a weekly IV infusion regimen to daily oral levosimendan.

Results Point of Contact

• Title: Douglas Hay
• Organization: Tenax Therapeutics

d.hay@tenaxthera.com

1-919-855-2110

Study Officials

• Stuart Rich, MD

  Tenax Therapeutics, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 9, 2018
• Study Start: April 9, 2019
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2023
• Last Updated: April 22, 2026
• Results First Posted: April 22, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)