Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Launched by SECRETOME THERAPEUTICS · Aug 15, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called STM-01 to see how safe it is and how well it can be tolerated by people with heart failure that is characterized by preserved ejection fraction, which means their heart can still pump blood effectively. The study is currently recruiting participants aged between 65 and 74 who have been diagnosed with this type of heart failure for at least six months and are stable in their condition. To be eligible, participants should have a heart function measurement (ejection fraction) of 50% or more and must be on standard heart failure medications at stable doses for at least a month before joining the trial.

Participants in this study can expect to receive the experimental medication in a controlled setting, where they’ll be closely monitored for any side effects. This trial is particularly focused on understanding the safety of STM-01, so it’s important for candidates to not be involved in other clinical studies or have certain medical conditions that could affect their participation. Overall, this trial aims to contribute valuable information about potential new treatments for heart failure, and your involvement could help advance care for others facing similar challenges.

Gender

ALL

Eligibility criteria

• Major 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.