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

Last updated: April 2, 2025
Sponsor: Secretome Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Congestive Heart Failure

Chest Pain

Heart Failure

Treatment

STM01

Clinical Study ID

NCT06560762
Phase 1 STM-01 HFpEF Study
  • Ages > 18
  • All Genders

Study Summary

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)

Eligibility Criteria

Inclusion

Major Inclusion Criteria:

  • Stable New York Heart Association (NYHA) Class II or III HF diagnosis, evident atleast 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 30days prior to Screening.

Exclusion

Major Exclusion Criteria:

  • Participant in any other study and has received any other investigational drugwithin 30 days prior to screening or 5-half-lives, whichever is longer, or any otherinvestigational implanted device within 30 days prior to screening, or are takingpart in a nonmedication study which, in the opinion of the Investigator, wouldinterfere with study compliance or outcome assessments.

  • Prior diagnosis of hypertrophic cardiomyopathy or a known infiltrative or storagedisorder causing HFpEF and/or cardiac hypertrophy, such as amyloidosis, Fabrydisease, or Noonan syndrome with LV hypertrophy.

  • Persistent or permanent atrial fibrillation and is not therapeuticallyanticoagulated for at least the 4 weeks prior to the initial screening visit or isnot adequately rate controlled within 6 months prior to informed consent accordingto investigator discretion.

  • Other medical or psychiatric conditions that, in the opinion of the Investigator,would preclude obtaining voluntary consent/assent or would confound the objectivesof the study.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: STM01
Phase: 1
Study Start date:
March 03, 2025
Estimated Completion Date:
December 15, 2025

Connect with a study center

  • Northwestern Medicine

    Chicago, Illinois 60611-5969
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

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