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

Phase 2

• Conditions: Hypertension Pulmonary Secondary Heart Failure; Right Sided Heart Failure With Normal Ejection Fraction; Heart Failure With Normal Ejection Fraction
• Interventions: Drug: Levosimendan 2.5 mg/ml Injectable Solution

• Registration Number: NCT03624010
• Lead Sponsor: Tenax Therapeutics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-09
• Study Start: 2018-11-14
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-04-30
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Provide a personally signed and dated informed consent document prior to initiation of any study-related procedures that are not considered standard of care.
2. Completed double-blind therapy in a PH-HFpEF clinical study sponsored by Tenax Therapeutics, Inc.
3. May, in the opinion of the Investigator, benefit from continued levosimendan treatment.
4. Female patients of childbearing potential must agree to use a highly effective method of contraception.
5. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

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Exclusion Criteria

1. Discontinued treatment in the parent study for any reason other than study completion or Sponsor termination of the study.
2. Pregnant or breastfeeding women.
3. Local access to commercially available levosimendan
4. Inability to comply with planned study procedures
5. Patients with scheduled lung or heart transplant or cardiac surgery
6. Dialysis developed since enrollment in parent study (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration)
7. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
8. Liver dysfunction with Child Pugh Class B or C (see Attachment 2)
9. Evidence of systemic bacterial, systemic fungal, or viral infection refractory to treatment
10. Weight >150kg
11. Systolic blood pressure (SBP) cannot be managed to ensure SBP >100 mmHg at initiation of study drug
12. Heart rate >100 bpm with study drug, persistent for at least 10 minutes at screening.
13. Hemoglobin < 80 g/L
14. Serum potassium < 3.0 mmol/L or > 5.5 mmol/L at baseline that is unresponsive to management

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levosimendan	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

Primary Outcome Measures

Name	Time	Method
Clinical Safety measured by number of adverse events (AEs )	2 years	Long-term safety profile of levosimendan measured by number of adverse events (AEs )

Secondary Outcome Measures

Name	Time	Method
Patient global assessment	2 years	Patient's assessment of well-being, based on a six-point Likert scale (1 =worst, 5= best)
6-minute walk test (6MWT)	2 years	Exercise capacity, measured as a distance traveled in 6 minutes
Clinical Events: Death and hospitalizations	2 years	Incidence of death or hospitalization
Physician's Assessment of Functional Class	2 years	Physician's Assessment of New York Heart Association (NYHA) Classification (one of four categories based on how much the patient is limited during physical activity. (Class I, no limitation of physical activity to Class IV, marked limitation of physical activity)

Trial Locations

Locations (9)

Stanford Healthcare; 🇺🇸 Stanford, California, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

UW Health University Hospital; 🇺🇸 Madison, Wisconsin, United States

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

UPMC Presbyterian Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States