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

Launched by GUANGDONG PROVINCIAL PEOPLE'S HOSPITAL · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well a medicine called Vericiguat works and how safe it is for people who have both chronic kidney disease and heart failure, especially those who are on hemodialysis (a treatment that filters the blood when the kidneys are not working well). Heart failure is common in people with kidney problems and can make their health worse. Vericiguat is a newer drug that helps the heart work better and may reduce hospital visits and the risk of heart-related death. This study aims to gather real-world information about how this medicine helps patients on dialysis, since this group hasn’t been studied much before.

People who might be eligible to join this study are adults between 18 and 80 years old with chronic kidney disease and heart failure, where their heart’s ability to pump blood is reduced. They should be receiving dialysis regularly with good treatment results, and their potassium levels should be within a safe range. Women who can become pregnant need to have a negative pregnancy test and agree to use birth control during the study. If accepted, participants will be observed while taking Vericiguat to see how well it works and if there are any side effects. The study plans to include about 118 patients and will run from mid-2025 to mid-2026. The goal is to find better ways to treat heart failure in people with kidney disease and improve their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • For women of childbearing potential, the pregnancy test result is negative at the screening visit and they agree.
• • Adequate contraceptive measures are taken.
• • The patient's dialysis adequacy assessment has reached Kt/V \>1.2, or URR\>70%.
• • The study protocol is implemented after being approved by the hospital ethics committee, and all patients voluntarily participate in this study
• Exclusion Criteria:
• • 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.
• • History of angioedema.
• • Hemodialysis patients with dialysis frequency less than 3 times per week.
• • Significant laboratory abnormalities at screening that interfere with the assessment of the safety or efficacy of the study drug (e.g., serum potassium \> 5.5 mmol/L or \< 3.5 mmol/L, serum sodium \< 130 mmol/L, or alanine aminotransferase or aspartate aminotransferase \> 2 times the upper limit of the normal range).
• • History of kidney transplantation or planned kidney transplantation within the next 12 months.
• • Use of medications for pulmonary arterial hypertension, such as sildenafil, during the study period.
• • Known allergy to the study treatment (active substance or excipients).
• • Any other disease or treatment that makes the patient ineligible to participate in this study or to complete the entire planned study period (e.g., active malignancy or other diseases that limit life expectancy to less than 12 months).
• • Pregnant or breastfeeding during the study period, or intending to become pregnant.