Pulmonary Hypertension Associated With HFpEF
Conditions
Keywords
PH-HFpEF, levosimendan, HFpEF, Heart Failure, Pulmonary Hypertension Group 2
Brief summary
The purpose of this study is to provide continued access to treatment with oral levosimendan (TNX-103) and to describe the safety of continued use of TNX-103 in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) who received TNX-103 in a parent study.
Interventions
DRUGTNX-103
Open-label oral levosimendan 1-3mg
Sponsors
Tenax Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Completed a TNX-103 parent study * Investigator confirmation that participant may derive clinical benefit from continued access to TNX-103 * Requirements related to childbearing potential, contraception, and egg/sperm donation
Exclusion criteria
* Investigator or Sponsor opinion that the participant is unsuitable due to safety, inability to comply, or factors that could compromise study integrity or participant well-being * Severe hepatic impairment or cirrhosis (Child-Pugh C) or active untreated hepatitis B or C with evidence of recent infection or viral replication * Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m² * Pregnancy or breastfeeding in females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs | From enrollment through study completion (up to 3 years) | The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs will be tabulated by system organ class and preferred term. |
Countries
United States
Outcome results
None listed