CompletedPhase 2

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

United States35 participantsStarted 2019-04-09

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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)

Clinical Safety

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

NCT IDNCT03624010

SponsorTenax Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-25

Results submitted2026-01-30

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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)