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

Secretome Therapeutics · NCT06560762

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
12
US sites recruiting
1
Study start
March 3, 2025
Record last updated
April 6, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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)

Being studied: STM01

Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

Study contacts (from the official record)

  • Malika Pasha · 4155352700 · mpasha@secretometx.com
Study in Participants With Heart Failure With Preserved Ejection… (NCT06560762) | Bored Studies