NCT07047547

A Study of Real-world Events of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure

A Prospective, Observational, Single-arm Study to Evaluate the Efficacy and Safety of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Chronic Kidney Disease often requires dialysis and other treatments to sustain life, and patients frequently suffer from heart failure, which exacerbates the disease burden. Research has shown that the incidence of heart failure is high among patients on dialysis, and the prognosis is poor. In recent years, there has been significant progress in the treatment of heart failure. Vericiguat, a novel sGC stimulator, can improve cardiac function and exercise tolerance, reduce the risk of cardiovascular death and hospitalization for heart failure, and has good tolerance. It has been included in relevant guidelines as a recommended drug. It has good tolerance in patients with renal insufficiency, and its therapeutic effect is consistent in patients with different levels of eGFR. However, there is a lack of prospective, randomized controlled studies targeting the special population of patients on dialysis. This study is a prospective, observational, single-arm study, planning to recruit 118 patients from June 2025 to June 2026. It aims to assess the efficacy and safety of Vericiguat in patients with heart failure on hemodialysis, to provide new evidence-based medical evidence for the treatment of heart failure in this special population, optimize the treatment strategy, and improve the prognosis and quality of life.

Conditions

• Hemodialysis Complication
• Heart Failure

Interventions

Type	Name	Description
DRUG	Vericiguat	Under the premise of ensuring safety, treat with a stable dose of Vericiguat 2.5mg PO QD for 2 weeks. After 2 weeks, increase the dose to 5mg PO QD. If blood pressure elevation occurs during the operation phase, the researchers suggest titrating or starting additional antihypertensive drugs, with a follow-up of 12 months. If the patient has tolerability issues (symptomatic hypotension or SBP\<90 mmHg), the dose should be reduced or discontinued.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-07-02
• Last updated: 2025-07-09

Locations

1 site across 1 country: China