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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vericiguat | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vericiguat | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction(LVEF) | Change from baseline in left ventricular ejection fraction(LVEF)between baseline and end of study | 12weeks |
| Left ventricular ejection fraction (LVEF) | Change from baseline in left ventricular ejection fraction (LVEF) between baseline and end of study | 12weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Left ventricular end diastolic volume (LVEDV) |
| Measure | Description | Time Frame |
|---|---|---|
| Neprilysin | The concentration of Neprilysis is measured by Human Neprilysin ELISA Kit as baseline and after 12 weeks following up | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuangxin Liu | Contact | (+86)020-83525210 | gdphgcp@gdph.org.an |
| Name | Affiliation | Role |
|---|---|---|
| Shuangxin Liu | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000603960 | vericiguat |
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LVEDV is measured as baseline and after 12 weeks follow-up.
| 12 weeks |
| Left atrial volume (LAV) | LAVis measured as baseline and after 12 weeks follow-up. | 12 weeks |
| 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. | 12 weeks |
| Pulmonary Artery Pressure | Pulmonary Artery Pressure is measured as baseline and after 12 weeks follow-up. | 12 weeks |
| Concentration of high-sensitivity serum troponin T | Blood samples will be collected for analysis of concentration of serum troponin every 4 weeks. | 12 weeks |
| Minnesota Heart Failure Quality of Life Questionnaire (LiHFe) | Change in health status is assessed using the disease-specific Minnesota Heart Failure Quality of L Questionnaire. | 12 weeks |
| Systolic and diastolic blood pressure | Systolic and diastolic blood pressure will be measured every 2 weeks. | 12 weeks |
| Electrocardiogram(ECG) | ECG QT Interval analysis was performed at baseline and 12 weeks follow-up. | 12 weeks |
| Estimated glomerular filtration rate(eGFR) | changes in estimated glomerular filtration rate(eGFR) | 12 weeks |