Status:
COMPLETED
The Effect of Vericiguat on Peripheral Vascular Function, Patient Health Status and Inflammation
Lead Sponsor:
Josef Stehlik
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Heart Failure
Heart Failure With Reduced Ejection Fraction (HFrEF)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The concept that direct stimulation of soluble guanylate cyclase (sGC) could be a particularly effective approach to increase cyclic guanosine monophosphate (cGMP) in conditions of increased inflammat...
Detailed Description
The incidence of heart failure (HF) continues to increase, along with its associated morbidity, mortality, and cost. Novel therapeutic options have been proposed to address the needs of especially the...
Eligibility Criteria
Inclusion
- History of chronic symptomatic HF (ACC/AHA Class C) and New York Heart Association (NYHA) Class II or III symptoms at the time of enrollment.
- Left ventricular ejection fraction (LVEF) of ≤45% assessed within 12 months prior to randomization by any imaging method.
- Systemic blood pressure ≥90/60 mmHg.
- Standard guideline-directed HF therapy.
- If female of reproductive potential, agrees to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by complying with abstinence from heterosexual activity or use (or have her partner use) contraception during heterosexual activity.
Exclusion
- Addition of a new disease-modifying HF pharmacotherapy or CRT-D in previous 4 weeks.
- Current or anticipated use of long-acting nitrates or nitric oxide (NO) donors including isosorbide dinitrate, isosorbide 5-mononitrate, pentaerythritol tetranitrate, nicorandil or transdermal nitroglycerin (NTG) patch, and molsidomine.
- Current or anticipated use of phosphodiesterase type 5 (PDE5) inhibitors such as vardenafil, tadalafil, and sildenafil.
- Current use or anticipated use of a soluble guanylate cyclase (sGC) stimulator such as riociguat.
- Known allergy or sensitivity to any sGC stimulator.
- Estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m2 or chronic dialysis.
- Patients who are pregnant or breastfeeding or plan to become pregnant or to breastfeed.
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05420012
Start Date
May 1 2023
End Date
October 24 2024
Last Update
October 8 2025
Active Locations (2)
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1
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
2
Veterans Affairs Salt Lake City Health Care System (VAMC)
Salt Lake City, Utah, United States, 84148