Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
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 join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This early study tests the safety of STM-01 and how well people handle repeated doses that increase in amount. It is for people with heart failure with preserved ejection fraction (HFpEF), meaning the heart pumps out a normal share of blood with each beat.
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)
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have stable heart failure for at least 6 months, with symptoms during regular or lighter daily activities (NYHA Class II or III).
- Have past test results that show heart failure.
- At screening, the heart pumps out at least 50% of its blood with each beat.
- Have organs that work well enough and bone marrow that can make enough blood cells at screening.
- Take usual heart failure medicines at steady doses for at least 30 days before screening.
Who can't join
- Have taken another study drug within 30 days before screening, or within the time it takes for the drug level to fall by half 5 times, whichever is longer.
- Have received an experimental implanted device within 30 days before screening.
- Are in a study without medicines that the study doctor thinks could affect following this study's rules or measuring its results.
- Have a prior diagnosis of a condition that makes the heart muscle too thick, or a known disease that causes material to build up in cells and leads to HFpEF or a thickened heart. Examples include amyloidosis, Fabry disease, and Noonan syndrome with a thickened left heart chamber.
- Have an ongoing irregular heartbeat called atrial fibrillation without adequate blood-thinning treatment for at least 4 weeks before screening, or without good heart rate control within 6 months before consent, as judged by the study doctor.
- Have another medical or mental health condition that the study doctor thinks could prevent free agreement to join or make the study results hard to judge.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (2)
IL
- Northwestern Medicine · Chicago, IL 60611-5969More trials in Chicago
TX
- UT Southwestern Medical Center · Dallas, TX 75390More trials in Dallas