Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Recruiting · NCT06560762 · Interventional (participants receive a specific treatment) · Lead sponsor: Secretome Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
STM01
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)
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed across 2 US states.
- Northwestern Medicine - Chicago, Illinois, United States
- UT Southwestern Medical Center - Dallas, Texas, United States