NCT06560762 Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
| NCT ID | NCT06560762 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Secretome Therapeutics |
| Condition | Heart Failure With Preserved Ejection Fraction (HFpEF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2025-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2025-03-03 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06560762 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Preserved Ejection Fraction (HFpEF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06560762 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06560762 currently recruiting?
Yes, NCT06560762 is actively recruiting participants. Contact the research team at mpasha@secretometx.com for enrollment information.
Where is the NCT06560762 trial being conducted?
This trial is being conducted at Chicago, United States, Dallas, United States.
Who is sponsoring the NCT06560762 clinical trial?
NCT06560762 is sponsored by Secretome Therapeutics. The trial plans to enroll 12 participants.
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