A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50+
SponsorVasa Therapeutics
About this trial
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Eligibility criteria
Qualifiers
Males or females ≥ 50 years of age at the time of signing the informed consent.
Diagnosis of HFpEF as defined by European Society of Cardiology or American College of Cardiology/American Heart Association criteria
NYHA Functional Class II or III
LVEF ≥ 50% demonstrated by echocardiography (ECHO) performed at Screening with evidence of heart failure
Disqualifiers
Female trial participant who is pregnant or breastfeeding.
Known hypersensitivity to VS-041.
Cardiovascular disease other than HFpEF
Active intercurrent illness such as acute bacterial or viral infection.
Trial design
Treatments tested in this trial
- VS-041
- Placebo
Treatment groups
42 Participants
are divided into 3 treatment groupsLocations
21Arkansas
Cardiology and Medicine Clinic72204, Little Rock United States
California
National Institute of Clinical Research92648, Huntington Beach United States
FOMAT93454, Santa Maria United States
Invivocure LLC91405, Van Nuys United States
Sponsors and collaborators
Vasa Therapeutics
Lead sponsor
Source ClinicalTrials.gov