A Study of Real-world Events of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGuangdong Provincial People's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Vericiguat
DrugUnder 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.
Treatment groups
118 Participants
are divided into 1 treatment groupGroup A: VericiguatExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Left ventricular ejection fraction(LVEF)
Change from baseline in left ventricular ejection fraction(LVEF)between baseline and end of study
Time frame
12weeks2
Left ventricular ejection fraction (LVEF)
Change from baseline in left ventricular ejection fraction (LVEF) between baseline and end of study
Time frame
12weeksSecondary outcomes
1
N terminal proB type natriuretic peptide (NT-prpBNP)
Blood samples will be collected for analysis of concentration of N terminal pro B type natriuretic pel proBNP) every 2 weeks
Time frame
12 weeks2
Left ventricular end diastolic volume (LVEDV)
LVEDV is measured as baseline and after 12 weeks follow-up.
Time frame
12 weeks3
Left atrial volume (LAV)
LAVis measured as baseline and after 12 weeks follow-up.
Time frame
12 weeks4
The ratio of mitral early diastolic blood flow peak and mitral annulus velocity (E/E')
E/E' is measured as baseline and after 12 weeks follow-up.
Time frame
12 weeksOther outcomes
1
Neprilysin
The concentration of Neprilysis is measured by Human Neprilysin ELISA Kit as baseline and after 12 weeks following up
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov