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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Vasa Therapeutics
Study ID
NCT07219511
Phase
PHASE1
Status
Recruiting

Conditions

  • Heart
  • Heart Failure With Preserved Ejection Fraction (HFPEF)

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VS-041 — DRUG
    VS-041 high dose, VS-041 low dose or Placebo tablet BID
  • Placebo — OTHER
    Placebo to match VS-041

Study Details

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

Key Dates

Start date
Nov 4, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
  • Experimental: Low Dose VS-041
  • Experimental: High Dose VS-041

Primary Outcome Measure

Participant incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: From Baseline to Day 28 ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
Cardiology and Medicine ClinicLittle RockArkansas72204-
National Institute of Clinical ResearchHuntington BeachCalifornia92648-
FOMATSanta MariaCalifornia93454-
Invivocure LLCVan NuysCalifornia91405-
New Generation of Medical ResearchHialeahFlorida33016-
Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216-
Amavita HealthNorth Miami BeachFlorida33169-
Broward Research CenterPembroke PinesFlorida33024-
Eagle Clinical ResearchChicagoIllinois60621-
Chicago Medical ResearchHazel CrestIllinois60429-
Methodist Medical Center of IllinoisPeoriaIllinois61606-
Louisiana Heart CenterSlidellLouisiana70458-
Washington UniversitySt LouisMissouri63110-
Ash Research ClinicBrickNew Jersey08724-
Erie County Medical CenterBuffaloNew York14215-
Duke University Medical CenterDurhamNorth Carolina27710-
Wake ForestWinston-SalemNorth Carolina27157-
Cleveland ClinicClevelandOhio44195-
Oklahoma Heart HospitalOklahoma CityOklahoma73120-
University of Texas Southwestern Medical CenterDallasTexas75231-
LinQ Research, LLCTomballTexas77375-

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