Heart Failure With Normal Ejection Fraction, Hypertension Pulmonary Secondary Heart Failure, Right Sided Heart Failure With Normal Ejection Fraction
Conditions
Brief summary
PH-HFpEF patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
Detailed description
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.
Interventions
DRUGLevosimendan
Initial: 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 a weekly 24 hour infusion. Transioned to: Daily Levosimendan capsules (1 mg TID)
Sponsors
Tenax Therapeutics, Inc.
Medpace, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Safety | Duration of study (for up to 2 years); Assessed at Weeks 3, 6, 12, 24, and 48 and Follow-Up Visit (termination visit). | Number of Adverse Events per Patient Population |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStuart Rich, MD
Tenax Therapeutics, Inc.
Participant flow
Recruitment details
Patients completing the Phase 2 HELP Study (TNX-LVO-04) were consented to open-label levosimendan.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 68.3 years STANDARD_DEVIATION 9.56 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 35 |
| other Total, other adverse events | 15 / 35 |
| serious Total, serious adverse events | 24 / 35 |
Outcome results
None listed