RecruitingPhase 1NCT06560762

Study 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)

Sponsor

Secretome Therapeutics

Enrollment

12 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Summary

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)

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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.

Exclusion Criteria4

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.