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)
Verified date | April 2021 |
Source | Tenax Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
PH-HFpEF patients will receive weekly open-label doses of levosimendan and be periodically evaluated for safety and effectiveness in extended use.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Tenax Therapeutics, Inc. |
United States,
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 |
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