Tests STM-01 safety in people with heart failure with preserved ejection fraction
Tests the safety of STM-01 in adults with heart failure with preserved ejection fraction.
Plain-language title generated from the registry record
Registry title: Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Key facts
- Where
- Chicago and Dallas, United StatesSee the 2 sites
- Phase
- Phase 1
Where in United States
- Northwestern MedicineChicago, United StatesNot yet recruiting
- UT Southwestern Medical CenterDallas, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Secretome Therapeutics
- Trial code
- NCT06560762
- Record updated
- 6 April 2025
- Original description
A Phase 1, Open label, Multiple Ascending Dose Study to Assess Safety and Tolerability of STM-01 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)Read full original descriptionShow less
A Phase 1, Open Label, Multiple Ascending Dose Study to Assess Safety and Tolerability of STM-01 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
A Phase 1, Open label, Multiple Ascending Dose Study to Assess Safety and Tolerability of STM-01 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Major Inclusion Criteria:; Stable New York Heart Association (NYHA) Class II or III HF diagnosis, evident at least 6 months prior to enrolment as confirmed by medical history; Documented prior objective evidence of heart failure; Screening ejection fraction ≥50%; Adequate bone marrow reserve and organ function at the Screening; Receiving standard of care heart failure therapy at stable doses for at least 30 days prior to Screening; Major Exclusion Criteria:; Participant in any other study and has received any other investigational drug within 30 days prior to screening or 5-half-lives, whichever is longer, or any other investigational implanted device within 30 days prior to screening, or are taking part in a nonmedication study which, in the opinion of the Investigator, would interfere with study compliance or outcome assessments; Prior diagnosis of hypertrophic cardiomyopathy or a known infiltrative or storage disorder causing HFpEF and/or cardiac hypertrophy, such as amyloidosis, Fabry disease, or Noonan syndrome with LV hypertrophy; Persistent or permanent atrial fibrillation and is not therapeutically anticoagulated for at least the 4 weeks prior to the initial screening visit or is not adequately rate controlled within 6 months prior to informed consent according to investigator discretion; Other medical or psychiatric conditions that, in the opinion of the Investigator, would preclude obtaining voluntary consent/assent or would confound the objectives of the study.