💬In plain words
What the trial is, and whether it could suit you
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 o
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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