Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tenax Therapeutics, Inc.
With
Medpace, Inc.
This study will enroll PH-HFpEF patients that have completed a controlled levosimendan study. These patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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)
