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The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD

Prognostic Effect of Isolated Nocturnal Hypertension Pattern With Nondialysis CKD

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03604003
Enrollment
252
Registered
2018-07-27
Start date
2018-11-30
Completion date
2023-12-30
Last updated
2018-07-27

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

Conditions

Chronic Kidney Disease

Keywords

CKD, bedtime dosing, isolated nocturnal hypertension

Brief summary

Isolated nocturnal hypertension (INH) has been studied among the general population and hypertensive patients. However, little insight is available on the prognostic effect of INH in patients with chronic kidney disease (CKD). This study investigated the prognostic effect of INH in a cohort of Chinese patients with nondialysis CKD.

Detailed description

Patients with or without isolated nocturnal hypertension will be enrolled in this study, and the patients with isolated nocturnal hypertension will be randomly divided into two groups and treated with bedtime or awakening doses of potassium losartan. Any patients who had any antihypertension medication at bedtime would withdrawal the drugs for 2 weeks before ABPM. Patients with isolated nocturnal hypertension will be randomly divided into two groups and received a bedtime or awakening dose of potassium losartan.

Interventions

treated with bedtime or awakening doses of potassium losartan

Sponsors

Fifth Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* daytime BP \<135/85mmHg,nighttime BP≥120/70mmHg;; * presence of CKD; * estimated GFR (eGFR)\<90 mL⁄ min ⁄ 1.73 m2 (using the Modification of Diet in Renal Disease Study equation) but \>30 mL⁄ min ⁄1.73 m2; * signed informed consent from participating patients.

Exclusion criteria

* pregnancy; * tumor; * infection; * renal replacement; * history of drug or alcohol abuse; * night- or shift-work employment; * treatment with steroids or hormonal therapy; * acute changes in eGFR \>30% in the past 3 months; * presence of acquired immunodeficiency syndrome; * CV disorders (unstable angina pectoris, heart failure, life-threatening arrhythmia, atrial fibrillation, kidney failure,and grade III or IV retinopathy); * intolerance to ambulatory BP monitoring (ABPM); * inability to communicate and comply with all of the study requirements.

Design outcomes

Primary

MeasureTime frameDescription
renal events and Cardiovascular events5 yearsdoubled creatine or renal replacement, myocardial infarction, heart failure, stroke, vascular reconstruction, peripheral vascular disease, non-traumatic amputation

Secondary

MeasureTime frameDescription
proteinuria5 years24h proteinuria \>1g
renal function5 yearseGFR\<30ml/min/1.73m2
Thickness of the medial membrane of the carotid artery5 yearscIMT \>1mm
Left ventricle weight index5 yearsLVMI \>115g/m2 (man) 和 \>95g/m2 (woman)

Contacts

Primary ContactCheng Wang, Doctor
wt770716@163.com18520762959
Backup ContactYe Zhu, Doctor
yezhu84@hotmail.com13600365603

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026