Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Sponsored by Secretome Therapeutics
About this study
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)
Where this study is enrolling
- Call 312.926.2000
Northwestern Medicine
Chicago, Illinois
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Who can participate
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.
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Trial data sourced from ClinicalTrials.gov.