A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

‣ 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.

Locations
United States
California
National Institute of Clinical Research
RECRUITING
Huntington Beach
FOMAT
RECRUITING
Santa Maria
Invivocure LLC
NOT_YET_RECRUITING
Van Nuys
Florida
New Generation of Medical Research
RECRUITING
Hialeah
Jacksonville Center for Clinical Research
RECRUITING
Jacksonville
Amavita Health
RECRUITING
North Miami Beach
Illinois
Chicago Medical Research
RECRUITING
Hazel Crest
Methodist Medical Center of Illinois
NOT_YET_RECRUITING
Peoria
Louisiana
Louisiana Heart Center
RECRUITING
Slidell
Missouri
Washington University
NOT_YET_RECRUITING
St Louis
North Carolina
Duke University
NOT_YET_RECRUITING
Durham
Wake Forest
NOT_YET_RECRUITING
Winston-salem
New Jersey
Ash Research Clinic
RECRUITING
Brick
New York
Erie County Medical Center
NOT_YET_RECRUITING
Buffalo
Ohio
Cleveland Clinic
NOT_YET_RECRUITING
Cleveland
Oklahoma
Oklahoma Heart Hospital
NOT_YET_RECRUITING
Oklahoma City
Pennsylvania
University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
Texas
UT Southwestern
NOT_YET_RECRUITING
Dallas
Contact Information
Primary
Clinical Team
Clinical@Vasatherapeutics.com
760-230-3398
Time Frame
Start Date: 2025-11-04
Estimated Completion Date: 2026-07
Participants
Target number of participants: 42
Treatments
Placebo_comparator: Placebo
Experimental: Low Dose VS-041
Experimental: High Dose VS-041
Sponsors
Leads: Vasa Therapeutics

This content was sourced from clinicaltrials.gov