Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06560762

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

Led by Secretome Therapeutics · Updated on 2025-04-06

12

Participants Needed

2

Research Sites

41 weeks

Total Duration

On this page

AI-Summary

What this Trial 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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Major

  • 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

Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Northwestern Medicine

Chicago, Illinois, United States, 60611-5969

Not Yet Recruiting

2

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

M

Malika Pasha

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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