What is Vericiguat studying for patients with heart failure and chronic kidney disease?

Vericiguat is being studied to assess its effects on heart function and safety in patients who have heart failure and are on dialysis for kidney disease. This study aims to provide new evidence to improve treatment options for this group. The research is sponsored by Guangdong Provincial People's Hospital.

Who may be eligible for this heart failure and kidney disease clinical trial?

Adults aged 18 to 80 with chronic kidney disease and heart failure with reduced ejection fraction may be eligible. Participants should have stable potassium levels and receive hemodialysis at least three times per week. People with recent heart attacks or low blood pressure are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this heart failure clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 80Years

All Genders

ID07047547

Study of Vericiguat Treatment for Adults With Chronic Kidney Disease and Heart Failure on Dialysis

Led by Guangdong Provincial People's Hospital · Updated on 2025-07-09

118

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 18Years - 80Years

All Genders

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

Research Team

Shuangxin Liu

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Study of Vericiguat Treatment for Adults With Chronic Kidney Disease and Heart Failure on Dialysis

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria