The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD

Chronic Kidney Disease Clinical Trial

Official title:

Prognostic Effect of Isolated Nocturnal Hypertension Pattern With Nondialysis CKD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03604003
• Other study ID #: ZDWY.SNK.003
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2018
• Source: Fifth Affiliated Hospital, Sun Yat-Sen University
• Contact: Cheng Wang, Doctor
• Phone: 18520762959
• Email: wt770716[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 252
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• potassium losartan
treated with bedtime or awakening doses of potassium losartan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal events and Cardiovascular events	doubled creatine or renal replacement, myocardial infarction, heart failure, stroke, vascular reconstruction, peripheral vascular disease, non-traumatic amputation	5 years
Secondary	proteinuria	24h proteinuria >1g	5 years
Secondary	renal function	eGFR<30ml/min/1.73m2	5 years
Secondary	Thickness of the medial membrane of the carotid artery	cIMT >1mm	5 years
Secondary	Left ventricle weight index	LVMI >115g/m2 (man) ? >95g/m2 (woman)	5 years