A Prospective, Observational, Single-arm Study to Evaluate the Efficacy and Safety of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure.
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.
• The patient is aged between 18 and 80 years
• Suffering from chronic kidney disease (eGFR\<90ml/min/1.73m², by CKD-EPI formula).
• They have chronic heart failure (NYHA class ≥II), with reduced ejection fraction, defined as LVEF≤50%.
• Their serum potassium level has been ≤4.8 mmol/L in the past month.
• For women of childbearing potential, the pregnancy test result is negative at the screening visit and they agree.
• Adequate contraceptive measures are taken.
• The patient's dialysis adequacy assessment has reached Kt/V \>1.2, or URR\>70%.
• The study protocol is implemented after being approved by the hospital ethics committee, and all patients voluntarily participate in this study