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Effects of Sacubitril/Valsartan (LCZ696) on Refractory Hypertension

Effects of Sacubitril/Valsartan (LCZ696) on Refractory Hypertension

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044672
Enrollment
Unknown
Registered
2021-03-25
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-09-28

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

Conditions

Refractory hypertension

Interventions

Group 1:Sacubitril/Valsartan 100mg bid or 200mg qd
Group 2:Sacubitril/Valsartan 200mg bid or 400mg qd

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 and <= 80 years, male or female; 2. Patients diagnosed with refractory hypertension who are receiving antihypertensive medications (a combination of three drugs, including one diuretic); 3. Volunteered to participate in the experiment and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Have a history of angioedema, drug-related or other causes; 2. Have a history of secondary hypertension or diagnostic basis, including but not limited to the following: renal parenchymal hypertension, renal vascular hypertension (bilateral renal artery stenosis), aortic stenosis, primary aldosteronism, Cushing's syndrome, pheochromocytoma, cystic nephropathy and drug-induced hypertension; 3. Patients with immune system diseases requiring treatment with hormones or immunosuppressants; 4. Clinical significance of abnormal liver and kidney function, including but not limited to: Serum potassium > 5.5mmoL/L;Blood ALT and/or AST > 3.0 x upper limit of normal (ULN);Serum creatinine > baseline 30%; eGFR < 60 mL /min1.73m2, any clinically significant laboratory abnormalities that the investigator considers to be likely to interfere with the efficacy and/or safety data evaluation of the study; 5. Patients with severe disease, ACS, PE, aortic dissection, cerebral hemorrhage, massive cerebral infarction, or malignant tumor within 3 months; 6. Patients undergoing hemodialysis or strict salt restriction therapy; 7. Gastrointestinal lesions or gastrointestinal surgery that may affect drug absorption or excretion, such as gastrectomy, active gastrointestinal inflammation, ulcers, or gastrointestinal bleeding; 8. Female subjects who are pregnant, lactating or have a positive pregnancy test; Or have family planning within 6 months after the end of the trial.

Design outcomes

Primary

MeasureTime frame
Changes in mean arterial pressure from baseline at the end of week 8;Changes in mean seated systolic pressure from baseline at the end of week 8;Changes in mean seated diastolic pressure from baseline at the end of week 8;

Secondary

MeasureTime frame
The effective rate of lowering blood pressure at the end of week 8;The rate of reaching mark of lowering blood pressure at the end of week 8;24h ambulatory blood pressure;

Countries

China

Contacts

Public ContactJiang Yinong

The First Affiliated Hospital of Dalian Medical University

yinongjiang@126.com+86 13332297168

Outcome results

None listed

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