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
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
CONDITIONS
Official 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...
- Male or female aged 50 years or older at the time of consent
- Diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF) by European or American criteria
- NYHA Functional Class II or III
- Left ventricular ejection fraction (LVEF) 50% or higher by echocardiography at screening with evidence of heart failure
- Elevated NT-proBNP 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 body mass index (BMI) between 18 and less than 45 kg/m2
- Males must agree to contraception requirements; females must be of non-childbearing potential
- Able to understand and willing to sign informed consent
- Willing and able to comply with trial procedures and restrictions
You will not qualify if you...
- Pregnant or breastfeeding females
- Known allergy or hypersensitivity to VS-041
- Cardiovascular diseases other than HFpEF
- Active illnesses such as acute bacterial or viral infections
- History of drug or alcohol abuse that may affect participation
- Active chronic viral infections like Hepatitis B, Hepatitis C, or HIV at screening
- Acute decompensated heart failure within 30 days before screening
- Lung disease within 12 months before screening
- History of active or untreated cancer or remission from significant cancer for less than 5 years
- Psychiatric or other conditions that may prevent following or completing the trial
- Participation in another clinical trial with an investigational product within the last 6 months
- Any other condition that may prevent participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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