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

Heart Failure With Normal Ejection Fraction Clinical Trial

Official title:

Open-Label Rollover Study of Levosimendan in Patients With Pulmonary Hypertension With Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03624010
• Other study ID #: TNX-LVO-05
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 14, 2018
• Est. completion date: February 2024

Study information

• Verified date: April 2021
• Source: Tenax Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Normal Ejection Fraction
• Hypertension
• Hypertension Pulmonary Secondary Heart Failure
• Hypertension, Pulmonary
• Right Sided Heart Failure With Normal Ejection Fraction

Intervention

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

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	UW Health University Hospital	Madison	Wisconsin
United States	University of Minnesota Medical Center	Minneapolis	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	Mayo Clinic	Rochester	Minnesota
United States	Stanford Healthcare	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Tenax Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Safety measured by number of adverse events (AEs )	Long-term safety profile of levosimendan measured by number of adverse events (AEs )	2 years
Secondary	6-minute walk test (6MWT)	Exercise capacity, measured as a distance traveled in 6 minutes	2 years
Secondary	Patient global assessment	Patient's assessment of well-being, based on a six-point Likert scale (1 =worst, 5= best)	2 years
Secondary	Physician's Assessment of Functional Class	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)	2 years
Secondary	Clinical Events: Death and hospitalizations	Incidence of death or hospitalization	2 years