Actively Recruiting
A Study of Real-world Events of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure
Led by Guangdong Provincial People's Hospital · Updated on 2025-07-09
118
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Real-world Events of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosis of chronic kidney disease with eGFR less than 90 ml/min/1.73m²
- Chronic heart failure with NYHA class II or higher and left ventricular ejection fraction 50% or less
- Serum potassium level of 4.8 mmol/L or lower in the past month
- Negative pregnancy test and agreement to use effective contraception for women of childbearing potential
- Dialysis adequacy assessment with Kt/V greater than 1.2 or URR greater than 70%
- Voluntary participation with ethics committee approval
You will not qualify if you...
- Acute renal failure
- Systolic blood pressure below 90 mmHg at screening or below 95 mmHg during the interdialytic period
- Isolated right heart failure caused by lung disease or dyspnea from non-cardiac causes
- History of myocardial infarction or stroke within the past 3 months
- History of angioedema
- Hemodialysis less than three times per week
- Significant abnormal lab results interfering with safety or efficacy assessment (e.g., serum potassium above 5.5 or below 3.5 mmol/L, serum sodium below 130 mmol/L, or liver enzymes more than twice the normal limit)
- History or planned kidney transplantation within 12 months
- Use of pulmonary arterial hypertension medications such as sildenafil during the study
- Known allergy to Vericiguat or its ingredients
- Other diseases or treatments limiting participation or life expectancy under 12 months
- Pregnancy, breastfeeding, or intention to become pregnant during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
S
Shuangxin Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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