Effect of changing angiotensin receptor blocker into angiotensin receptor-neprilysin inhibitor on out-of-office blood pressures in hypertensive patients with chronic kidney disease stage G4-5

Not Applicable

Recruiting

• Conditions: Hypertensive patients with CKD stage G4-to-G5; Hypertension, Chronic kidney disease; D006973, D051436

• Registration Number: JPRN-jRCT1031220149
• Lead Sponsor: Kinguchi Sho

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

(i) Aged >= 18 years of age on day of signing informed consent (male/female)
(ii) CKD of G4-to-G5 categories (eGFR < 30 ml/min/1.73m2), not yet on dialysis
(iii) Current treatment with ARB (regardless of other antihypertensive drugs use, except for angiotensin converting enzyme (ACE) inhibitors and aliskiren)
(iv) Systolic office blood pressure >= 130 mmHg, or diastolic office blood pressure >= 80 mmHg
(Systolic office blood pressure >= 140 mmHg, or diastolic office blood pressure >= 90 mmHg, if participants are 75 years of age or older without proteinuria
(v) Written informed consent

Exclusion Criteria

(i) Bilateral renal artery stenosis, or renal artery stenosis in patients who have only one kidney.
(ii) Patients who were pregnant, or breastfeeding women.
(iii) Hyperkalemia (Serum potassium > 5.5 mEq/L)
(iv) History of angioedema
(v) Severe hepatic insufficiency and/or significant abnormal liver function (alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of the normal range, Child-Pugh category C)
(vi) Hypersensitivity for sacubitril/valsartan.
(vii) Current treatment with ACE inhibitors, or within 36 hours after ACE inhibitors discontinuance.
(viii) Current treatment with aliskiren.
(ix) Patients judged by the investigator to be ineligible for some other reason.
(x) office, or home, systolic blood pressure >= 200mmHg
(xi) Current treatment with maximum dose of ARBs
(xii) History of acute coronary syndrome, or stroke within the past 3 months.
(xiii) Patients under treatment with malignant tumor.
(xiv) New York Heart Association class II to IV heart failure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in 24 hour mean systolic blood pressure measured by ABPM at 12 weeks after sacubitril/valsartan administration instead of ARB participants are using at enrollment.