Actively Recruiting
A Prospective, Observational, Single-arm Study to Evaluate the Efficacy and Safety 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with chronic kidney disease who are on hemodialysis and also have heart failure, a condition that worsens their health and prognosis. This study evaluates the use of Vericiguat, a new drug that may improve heart function and exercise ability while lowering the risk of heart-related hospitalization and death. Vericiguat has shown good tolerance in patients with kidney problems, but its effects specifically in dialysis patients need further study. The treatment involves starting patients on a low dose of Vericiguat (2.5 mg taken orally once daily) for two weeks, then increasing to 5 mg once daily if tolerated. If blood pressure rises, doctors may adjust the medication or add blood pressure drugs. The treatment will continue with follow-up for 12 months, with dose adjustments or discontinuation if side effects like low blood pressure occur. Participants will be monitored through various heart and kidney function tests including echocardiograms, blood pressure measurements, blood tests for heart stress markers, and quality of life questionnaires. The main measurement is the change in left ventricular ejection fraction after 12 weeks. Safety and effectiveness will be observed over one year to provide new evidence to improve care for heart failure patients on dialysis.
CONDITIONS
Brief 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...
- Aged between 18 and 80 years
- Have chronic kidney disease with eGFR less than 90 ml/min/1.73m²
- Have chronic heart failure with NYHA class II or higher and left ventricular ejection fraction 50% or less
- Serum potassium level below or equal to 4.8 mmol/L in the past month
- Negative pregnancy test and use of adequate contraception if female of childbearing potential
- Dialysis adequacy 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 less than 95 mmHg during interdialytic period
- Isolated right heart failure caused by lung disease or non-cardiac causes of breathlessness
- History of heart attack or stroke within past 3 months
- History of angioedema
- Receiving hemodialysis less than 3 times per week
- Significant lab abnormalities interfering with safety or efficacy assessment (e.g., potassium above 5.5 or below 3.5 mmol/L, sodium below 130 mmol/L, liver enzymes over twice normal)
- History or planned kidney transplant within 12 months
- Use of pulmonary arterial hypertension medications during study
- Allergy to Vericiguat or its ingredients
- Any other disease or treatment limiting life expectancy to less than 12 months
- Pregnant, breastfeeding, or planning pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive Vericiguat starting with a stable dose of 2.5mg once daily for 2 weeks, then increase to 5mg once daily. Dose adjustments may occur based on blood pressure and tolerability. Treatment includes follow-up to monitor safety and efficacy.
Regular follow-up visits during treatment
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
S
Shuangxin Liu
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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