The Effect of Vericiguat on Peripheral Vascular Function, Patient Health Status and Inflammation

PHASE4CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

May 1, 2023

Primary Completion Date

October 24, 2024

Study Completion Date

October 24, 2024

Conditions
Heart FailureHeart Failure With Reduced Ejection Fraction (HFrEF)
Interventions
DRUG

Vericiguat

A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.

DRUG

Placebo

A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.

Trial Locations (2)

84132

University of Utah Hospital, Salt Lake City

84148

Veterans Affairs Salt Lake City Health Care System (VAMC), Salt Lake City

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Josef Stehlik

OTHER

NCT05420012 - The Effect of Vericiguat on Peripheral Vascular Function, Patient Health Status and Inflammation | Biotech Hunter | Biotech Hunter