A Study of Real-world Events of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGuangdong Provincial People's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Acute renal failure.
Systolic blood pressure below 90 mmHg at screening (systolic blood pressure less than 95 mmHg during interdialytic period).
Isolated right heart failure due to pulmonary disease; the primary cause of dyspnea is due to non-cardiac, non-heart failure reasons, such as acute or chronic respiratory diseases.
History of myocardial infarction or cerebrovascular event within the past 3 months.
Trial design
Treatments tested in this trial
- Vericiguat
Treatment groups
118 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov