Actively Recruiting
Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Led by Secretome Therapeutics · Updated on 2025-04-06
12
Participants Needed
2
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
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
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Northwestern Medicine
Chicago, Illinois, United States, 60611-5969
Not Yet Recruiting
2
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
M
Malika Pasha
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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