A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
- Conditions
- HeartHeart Failure With Preserved Ejection Fraction (HFPEF)
- Interventions
- Other: Placebo
- Registration Number
- NCT07219511
- Lead Sponsor
- Vasa Therapeutics
- Brief Summary
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
Participants must meet all inclusion criteria to be eligible for trial participation.
- 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 and evidence of heart failure with history of at least one HF hospitalization
- Elevated NT-proBNP at Screening
- NordicPRO-C6™ ≥ 11 ng/mL at Screening.
- Stable dose of all concomitant HF medications for at least 4 weeks prior to Screening.
- Body weight of at least 110 lbs (50 kg) and body mass index (BMI) within the range ≥ 18 to < 45 kg/m2.
- Males must agree to the contraception requirements and females must be of non-childbearing potential
- Able to understand and willing to sign a written informed consent form (ICF).
- Willing and able to comply with trial procedures and restrictions listed in the ICF and in this protocol.
- 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.
- History of illicit drug or alcohol abuse or addiction that in the opinion of the PI could affect participation.
- Serologic evidence of Hepatitis B or Hepatitis C or human immunodeficiency virus (HIV) at Screening.
- Acute decompensated HF within 30 days of Screening
- Lung disease within 12 months prior to Screening
- History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
- History of any other condition including psychiatric disorders that, in the opinion of the PI, may preclude the participant from following and completing the protocol.
- Have participated within the last 6 months in a clinical study involving an investigational product.
- Any other reason which, in the opinion of the PI, would prevent the participant from participating in the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Low Dose VS-041 VS-041 - High Dose VS-041 VS-041 -
- Primary Outcome Measures
Name Time Method Participant incidence of treatment-emergent adverse events (TEAEs) From Baseline to Day 28 To evaluate the safety and tolerability of VS-041 in participants with HFpEF
Change from baseline over time in serum NordicPRO-C6 From Baseline to Day 28 To evaluate the impact of VS-041 on key biomarkers in participants with HFpEF
Change from baseline over time in serum endotrophin From Baseline to Day 28 To evaluate the impact of VS-041 on key biomarkers in participants with HFpEF
Change from baseline over time in serum NT-proBNP From Baseline to Day 28 To evaluate the impact of VS-041 on key biomarkers in participants with HFpEF
- Secondary Outcome Measures
Name Time Method Pharmacokinetic profiles and parameters derived for VS-041 - Tmax From Baseline to Day 28 To assess PK of twice-daily VS-041 in participants with HFpEF
Pharmacokinetic profiles and parameters derived for VS-041 - Cmax From Baseline to Day 28 To assess PK of twice-daily VS-041 in participants with HFpEF
Trial Locations
- Locations (19)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
National Institute of Clinical Research
🇺🇸Huntington Beach, California, United States
FOMAT
🇺🇸Santa Maria, California, United States
Invivocure LLC
🇺🇸Van Nuys, California, United States
New Generation of Medical Research
🇺🇸Hialeah, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Amavita Health
🇺🇸Miami, Florida, United States
Chicago Medical Research
🇺🇸Hazel Crest, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Louisiana Heart Center
🇺🇸Slidell, Louisiana, United States
Scroll for more (9 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States