Status:
RECRUITING
Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Lead Sponsor:
Secretome Therapeutics
Conditions:
Heart Failure With Preserved Ejection Fraction (HFpEF)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 Criteria
Inclusion
- Major
- 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
- 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.
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06560762
Start Date
March 3 2025
End Date
December 15 2025
Last Update
April 6 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwestern Medicine
Chicago, Illinois, United States, 60611-5969
2
UT Southwestern Medical Center
Dallas, Texas, United States, 75390