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Efficacy and safety of sacurabatril valsartan in patients with heart failure and renal insufficiency

Efficacy and Safety of Shakubatravasartan in Patients with Chronic Heart Failure and Chronic kidney disease(CKD)stage 1-3

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028468
Enrollment
Unknown
Registered
2019-12-22
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-05-11

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

Conditions

Chronic Heart Failure and Chronic kidney disease(CKD)stage 1-3

Interventions

ARNI group:Treatment with ARNI
ARB group:Treatment with Valsartan

Sponsors

The First Central Hospital of Tianjin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Chronic heart failure (NYHA grade heart function level II-IV, LVEF not exceeding 50%, plasma BNP level >= 150 pg / ml or NT-proBNP level >= 600 pg / ml, if the patient has had heart failure in the past 12 months Hospitalized, BNP >= 100 pg / ml or NTproBNP >= 400 pg / ml) with chronic kidney disease (CKD) stage 1-3, have received standard anti-heart failure treatment for at least 4 weeks. 2. Not less than 18 years old. 3. Ability to understand and follow research protocols. 4. Sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Severe infection (with clear infection focus; systemic inflammatory response exists; systolic blood pressure is lower than 90mmHg or 40mmHg lower than the original basic value, cannot recover after 1 hour of fluid resuscitation or requires vasoactive drugs to maintain; accompanied by low tissue Perfusion, such as urine volume less than 30ml / h or acute conscious disturbance; blood culture has microbial growth); (2) history of bronchial asthma and other serious lung diseases; (3) severe liver function impairment (Child-pugh C grade), biliary cirrhosis and cholestasis; (4) Severe renal impairment (eGFR stage 4-5) or eGFR reduction> 35% when screened to randomization; (5) Malignant tumors and cachexia; (6) Appropriate nephrotoxic antibiotics or antifungal drugs in the last 2 weeks; (7) currently being treated with cholesterol or colestipol; (8) symptomatic hypotension with systolic blood pressure 5.2mmol / L at screening (or > 5.4mmol / L at randomization); (10) history of angioedema; (11) severe bilateral renal artery stenosis; (12) Pregnancy and breastfeeding Women; (13) Known allergies to ARB or ARNI; (14) Acute kidney injury; (15) Patients with albumin 3.5g; (16) Current acute decompensated heart effort Failure (aggravation of chronic heart failure, manifested as signs and symptoms requiring intravenous treatment); (17) Acute coronary syndrome, stroke, transient ischemic attack, heart, carotid artery or other major cardiovascular surgery, PCI or carotid artery Angioplasty; (18) coronary or carotid artery disease may require surgery or percutaneous intervention within 6 months; (19) cathode ray tube device implantation or intentional implantation of cathode ray within 3 months before the visit (20) history of heart transplantation or on the transplant list or use of left ventricular assist device; (21) non-cardiac associated diseases with an estimated survival of less than 1 year; (22) diagnosis of perinatal within 12 months before the visit Period or chemotherapy-induced cardiomyopathy; (23) symptomatic bradycardia or second- and third-degree atrioventricular block without pacemaker; (24) significant mitral and / or aortic valve disease, except Mitral regurgitation secondary to left ventricular dilatation; (25) There are other hemodynamically significant LV outflow tract obstructions, including aorta and sub-aortic stenosis; (26) Any surgical or medical condition that may significantly change the absorption, distribution, metabolism or excretion of study drugs, including But it is not limited to any of the following cases: 12 months prior to the visit, a history of active inflammatory bowel disease. Duodenal or gastric ulcers occurred 3 months before the visit. Evidence of liver disease determined by any of the following: aspartate aminotransferase or alanine aminotransferase value exceeds the upper limit of 2 times the normal value, history of hepatic encephalopathy, history of esophageal varices, or history of portal shunt; (27) Current participation Testing of other drugs and equipment.

Design outcomes

Primary

MeasureTime frame
blood pressure;Resting heart rate;Left ventricular ejection fraction;Serum creatinine;24-hour urine protein;NT-proBNP;

Countries

China

Contacts

Public ContactLu Chengzhi

The First Central Hospital of Tianjin

lucz8@126.com+86 13512967656

Outcome results

None listed

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