Clinical trial NCT03624010: Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
Official title: Open-Label Rollover Study of Levosimendan in Patients With Pulmonary Hypertension With Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hypertension Pulmonary Secondary Heart Failure
Right Sided Heart Failure With Normal Ejection Fraction
Heart Failure With Normal Ejection Fraction
Lead sponsor: Tenax Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Safety measured by number of adverse events (AEs )
timeFrame: 2 years
Secondary outcomes:
measure: 6-minute walk test (6MWT)
timeFrame: 2 years
measure: Patient global assessment
timeFrame: 2 years
measure: Physician's Assessment of Functional Class
timeFrame: 2 years
measure: Clinical Events: Death and hospitalizations
timeFrame: 2 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Healthcare
state: California
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Madison
country: United States
facility: UW Health University Hospital
state: Wisconsin
Study officials:
affiliation: Tenax Therapeutics, Inc.
name: Stuart Rich, MD
role: PRINCIPAL_INVESTIGATOR
References: