Bedtime Potassium Losartan on CKD With Nocturnal Hypertension Patients With Nondipping Blood Pressure Pattern

Chronic Kidney Disease Patients Clinical Trial

Official title:

Effect of Potassium Losartan With Bedtime Dosing on Chronic Kidney Disease Patients With Nondipping Blood Pressure Pattern

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03603938
• Other study ID #: ZDWY.SNK.002
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: June 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

Nondipping blood pressure (BP) pattern is a potential independent risk factor for chronic kidney disease (CKD). Whether bedtime administration of potassium losartan has benefit for anti-hypertension and the prognosis of CKD patients is not clear. Patients with nondipping BP pattern or dipping BP pattern were enrolled in this study, and the patients with nondipping BP pattern were randomly divided into two groups and treated with bedtime or awakening doses of potassium losartan.

Description:

Patients with nondipping BP pattern or dipping BP pattern were enrolled in this study, and the patients with nondipping BP pattern were 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 nondipping BP were then randomly divided into two groups and received a bedtime or awakening dose of potassium losartan. Patients with dipping BP were called the dipper group, while the patients with nondipping BP were called the awakening dose group or bedtime dose group, according to the time of drug administration.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 189
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

Inclusion Criteria:

• night BP is SBP=120mmHg and/or DBP=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 Patients
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
China	The fifth affiliated hospital of Sun Yat-sen university	Zhuhai	Guangdong

Sponsors (1)

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

Country where clinical trial is conducted

China, 

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