NCT07047547Recruiting
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.
Source: ClinicalTrials.gov · Last updated 9 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 118 (estimated)
- First submitted
- 24 Jun 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Guangdong Provincial People's Hospital
- Diseases
- Chronic kidney disease, Heart failure
- NCT number
- NCT07047547
What you commit to
- Study type: Interventional
- Planned participants: 118
- From 1 Jun 2025 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Acute renal failure.
- 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.
- 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).
Lab values
- 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).
Other
- Systolic blood pressure below 90 mmHg at screening (systolic blood pressure less than 95 mmHg during interdialytic period).
- Hemodialysis patients with dialysis frequency less than 3 times per week.
- Pregnant or breastfeeding during the study period, or intending to become pregnant.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.