Assessing STM-01 for heart failure with preserved ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study evaluates the safety and tolerability of STM-01 in participants diagnosed with heart failure with preserved ejection fraction (HFpEF). The study involves multiple ascending doses of the investigational drug to determine its effects on patients who have stable NYHA Class II or III heart failure. Participants must have a documented history of heart failure and be on stable standard care therapy. The study aims to gather preliminary data on the drug's safety profile in this specific patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• Northwestern Medicine
  Chicago, Illinois, United States Not yet recruiting

Study contacts

• Study coordinator: Malika Pasha
• Email: mpasha@secretometx.com
• Phone: 4155352700

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Resmetirom for MASH with HFpEF in adults

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• Iron infusion and MRI to study inflammation in HFpEF

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.