Actively Recruiting
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Led by Vasa Therapeutics · Updated on 2026-04-09
42
Participants Needed
21
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and biomarker effects of VS-041 in people with Heart Failure with Preserved Ejection Fraction (HFpEF), a type of heart condition where the heart pumps normally but is stiff. This Phase 1 trial aims to understand how VS-041 affects specific heart-related biomarkers and to monitor any treatment-emergent adverse events. The study is sponsored by Vasa Therapeutics and focuses on adults aged 50 and older diagnosed with HFpEF. Participants will be randomly assigned to receive either a high dose or low dose of VS-041, or a matching placebo tablet, taken twice daily. The treatment period lasts 28 days, during which safety, tolerability, and biomarker changes in the blood, including NordicPRO-C6, endotrophin, and NT-proBNP levels, will be closely tracked. Pharmacokinetic profiles of the drug will also be assessed to understand how the body processes VS-041. During the study, participants will undergo screening to confirm eligibility, including heart function tests and biomarker measurements. Throughout the 28-day treatment, researchers will monitor participants for side effects and changes in biomarkers. The main outcomes measured are adverse events and changes in serum biomarkers from baseline to Day 28. Participants must be willing to follow study procedures, including medication adherence and attending scheduled visits, to help assess the drug's safety and biological effects.
CONDITIONS
Brief Title
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 50 years or older at the time of consent
- Diagnosis of HFpEF by European or American heart society criteria
- New York Heart Association Functional Class II or III
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiography at screening
- Elevated NT-proBNP biomarker at screening
- NordicPRO-C6 level of 11 ng/mL or higher at screening
- Stable dose of all heart failure medications for at least 4 weeks before screening
- Body weight at least 110 lbs (50 kg) and BMI between 18 and less than 45 kg/m2
- Males must agree to contraception requirements; females must be of non-childbearing potential
- Ability to understand and willing to sign informed consent
- Willingness and ability to follow trial procedures and restrictions
You will not qualify if you...
- Female participants who are pregnant or breastfeeding
- Known allergy or hypersensitivity to VS-041
- Cardiovascular diseases other than HFpEF
- Active infections like acute bacterial or viral illness
- History of illicit drug or alcohol abuse that may affect participation
- Active chronic viral infections such as Hepatitis B, Hepatitis C, or HIV at screening
- Acute worsening of heart failure within 30 days before screening
- Lung disease diagnosed within 12 months prior to screening
- History of active or untreated cancer or remission less than 5 years
- Psychiatric or other conditions that may prevent following the protocol
- Participation in another clinical trial with investigational product within last 6 months
- Any other condition that may prevent safe participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 days
Participants receive VS-041 high dose, VS-041 low dose, or placebo tablets twice daily.
Visits throughout the 28-day treatment period
Trial Site Locations
Total: 21 locations
1
Cardiology and Medicine Clinic
Little Rock, Arkansas, United States, 72204
Actively Recruiting
2
National Institute of Clinical Research
Huntington Beach, California, United States, 92648
Actively Recruiting
3
FOMAT
Santa Maria, California, United States, 93454
Actively Recruiting
4
Invivocure LLC
Van Nuys, California, United States, 91405
Actively Recruiting
5
New Generation of Medical Research
Hialeah, Florida, United States, 33016
Actively Recruiting
6
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Actively Recruiting
7
Amavita Health
North Miami Beach, Florida, United States, 33169
Actively Recruiting
8
Broward Research Center
Pembroke Pines, Florida, United States, 33024
Actively Recruiting
9
Eagle Clinical Research
Chicago, Illinois, United States, 60621
Actively Recruiting
10
Chicago Medical Research
Hazel Crest, Illinois, United States, 60429
Actively Recruiting
11
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61606
Not Yet Recruiting
12
Louisiana Heart Center
Slidell, Louisiana, United States, 70458
Actively Recruiting
13
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
14
Ash Research Clinic
Brick, New Jersey, United States, 08724
Actively Recruiting
15
Erie County Medical Center
Buffalo, New York, United States, 14215
Actively Recruiting
16
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
17
Wake Forest
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
18
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
19
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
20
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75231
Actively Recruiting
21
LinQ Research, LLC
Tomball, Texas, United States, 77375
Actively Recruiting
Research Team
C
Clinical Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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