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A multicenter, open clinical trial scheme for the efficacy and safety of Sacubitril Valsartan Sodium Tablets in the treatment of chronic heart failure in maintenance peritoneal dialysis patients

A multicenter, open clinical trial scheme for the efficacy and safety of Sacubitril Valsartan Sodium Tablets in the treatment of chronic heart failure in maintenance peritoneal dialysis patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038162
Enrollment
Unknown
Registered
2020-09-11
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic heart failure

Interventions

Treatment group:Sacubitril Valsartan

Sponsors

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Maintenance peritoneal dialysis for end-stage renal disease >= 3 months; (2) Chronic heart failure * (diagnostic criteria refer to Framingham Diagnostic Criteria for Heart Failure, Chinese Guidelines for Diagnosis and Treatment of Heart Failure 2018), medical history >= 3 months, and no use of Shakubatroxobin within 3 months before admission; (3) NYHA classification of cardiac function was II-IV. (4) Left ventricular ejection fraction (LVEF) in echocardiography was less than 55%. (5) The expected survival time is more than 6 months; (6) The monitored blood potassium in the past three months was all < 5.5 mmol/L. (7) Aged 18-80 years; (8) Good compliance; (9) The subjects sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) According to the judgment of the researcher, the patient may not be able to continue peritoneal dialysis treatment during the study period; (2) Those who are undergoing hemodialysis and peritoneal dialysis simultaneously; (3) Acute myocardial infarction occurred in recent 1 month; (4) Symptomatic hypotension with systolic blood pressure < 95mmHg during screening; (5) Suffering from acute decompensated heart failure when entering the group; (6) Severe valvular heart disease, pulmonary heart disease and complex congenital heart disease; (7) Severe hepatic insufficiency; (8) Previous history of angioedema; (9) Malignant tumors and mental disorders; (10) Allergic to ARB, Sacubitril Valsartan and other drugs; (11) Those who have participated in relevant clinical trials in recent 3 months.

Design outcomes

Primary

MeasureTime frame
NT-proBNP;Left ventricular ejection fraction;—

Countries

China

Contacts

Public ContactYang Hongtao

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

tjtcmht@126.com+86 13820481917

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026