Impact of Vericiguat on Hemodynamics of Heart Failure

NCT05704478 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 22-2321
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Vericiguat is a new drug that was recently approved by the Food and Drug Administration for patients with heart failure. In a large randomized controlled trial, this drug was found to help patients with heart failure live longer and stay out of the hospital more than normal treatment for heart failure. However, it is unclear how this drug positively impacts "hemodynamics", meaning how the heart functions during activity/exercise, and how it may also help blood pressure and health of the blood vessels and autonomic nervous system. This study, funded by the drug manufacturer, Merck Corp, will enroll 30 patients with heart failure. The patients will undergo baseline testing, and then be randomized to either receive vericiguat or a placebo for about three months, and then come back for follow-up testing to learn more about how the drug impacts heart function.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• cardiac output, L/min

  cardiac output from heart catheterization

  3 months

Secondary Outcomes (4)

• Quality-of-life assessment

  3 months

• oxygen uptake (VO2), ml/kg/min

  3 months

• Pulmonary arterial pressure, mmHg

  3 months

• Pulmonary capillary wedge pressure, mmHg

  3 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Participants will be administered the drug vericiguat

Drug: Vericiguat

Control

PLACEBO COMPARATOR

Participants will be administered a placebo

Drug: Vericiguat

Interventions

Vericiguat DRUG

soluble guanylate cyclase stimulator

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years of age or greater with New York Heart Association functional class II, III, or IV HFrEF with left ventricular ejection fraction \< 45% within 12 months of enrollment;
• elevated brain natriuretic peptide level (BNP) within 30 days of enrollment; and
• history of worsening congestion, defined as a HF-hospitalization within 6 months of enrollment or increase in diuretic therapy without hospitalization within three months of enrollment.

You may not qualify if:

• systolic blood pressure (SBP) below 100mmHg;
• use of long-acting nitrates, soluble guanylate cyclase stimulators, or phosphodiesterase type 5 inhibitors;
• use of intravenous inotropes or implantable left ventricular assist devices;
• use of anticoagulants with an inability to temporarily hold these medications for procedures or to keep the international normalized ratio \< 2.5 units;
• uncontrolled arrhythmias;
• noncardiac factors that may limit the ability to exercise (e.g. severe osteoarthritis, peripheral vascular disease, severe pulmonary disease); and
• pregnancy.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

vericiguat

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind, both participant and provider. Blinding to be coordinated by research coordinator
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 30, 2023
• Study Start: January 1, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)