Impact of Vericiguat on Hemodynamics of Heart Failure

• Status: Not yet recruiting
• Trial end date: 2027-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver

Criteria

Inclusion Criteria:

1. 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;

2. elevated brain natriuretic peptide level (BNP) within 30 days of enrollment; and

3. 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.

Exclusion Criteria:

1. systolic blood pressure (SBP) below 100mmHg;

2. use of long-acting nitrates, soluble guanylate cyclase stimulators, or phosphodiesterase type 5 inhibitors;

3. use of intravenous inotropes or implantable left ventricular assist devices;

4. use of anticoagulants with an inability to temporarily hold these medications for procedures or to keep the international normalized ratio < 2.5 units;

5. uncontrolled arrhythmias;

6. noncardiac factors that may limit the ability to exercise (e.g. severe osteoarthritis, peripheral vascular disease, severe pulmonary disease); and

7. pregnancy.