RecruitingNot ApplicableNCT07047547

A Study of Real-world Events of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure

A Prospective, Observational, Single-arm Study to Evaluate the Efficacy and Safety of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure.


Sponsor

Guangdong Provincial People's Hospital

Enrollment

118 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is examining vericiguat — a medication approved for heart failure — in patients who have both heart failure with reduced pumping function AND chronic kidney disease (including those on dialysis), to see how it performs in this combined, high-risk patient group in a real-world setting. **You may be eligible if...** - You are 18–80 years old with chronic kidney disease (reduced kidney function) - You have heart failure with reduced ejection fraction (weak pumping heart) at NYHA class II or higher - Your potassium level is within a safe range - If on dialysis, your dialysis is adequately removing waste **You may NOT be eligible if...** - You have acute (sudden) kidney failure - Your blood pressure is critically low - You had a heart attack or stroke in the last 3 months - You have severe lung disease or right-sided heart failure from lung problems - You are pregnant or breastfeeding - You take pulmonary hypertension medications like sildenafil - You are scheduled for a kidney transplant within 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVericiguat

Under the premise of ensuring safety, treat with a stable dose of Vericiguat 2.5mg PO QD for 2 weeks. After 2 weeks, increase the dose to 5mg PO QD. If blood pressure elevation occurs during the operation phase, the researchers suggest titrating or starting additional antihypertensive drugs, with a follow-up of 12 months. If the patient has tolerability issues (symptomatic hypotension or SBP\<90 mmHg), the dose should be reduced or discontinued.


Locations(1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

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NCT07047547


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