Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy

Phase 4

Completed

• Conditions: Diabetes Mellitus; Essential Hypertension; Renal Failure

• Registration Number: NCT00295555
• Lead Sponsor: Yokohama City University Medical Center

Brief Summary

Few studies have reported the effect of alpha1-adrenergic antagonists on 24-h blood pressure and regulation of sympathetic nervous activity in hypertensive patients with diabetic nephropathy. Using ambulatory blood pressure monitoring devices equipped with spectral analysis of heart rate variability, we assess the effects of doxazosin on blood pressure in diabetic nephropathy patients and compare the results with those in patients with essential hypertension, patients with diabetes mellitus and patients with chronic nephropathy.

Detailed Description

The study is an open-labeled parallel prospective trial comparing the effects of doxazosin (2-8 mg/day) on 24-h blood pressure and autonomic nervous activity. Hypertensive patients with non-insulin-dependent diabetic nephropathy, patients with essential hypertension, patients with diabetes mellitus and patients with chronic nephropathy undergo ambulatory blood pressure monitoring before and after treatment with doxazosin. Simultaneously, spectral analysis is performed to calculate the high frequency components as a marker of parasympathetic nervous activity, and the low frequency components/high frequency components ratios as an index of the sympathovagal balance.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2006-02-21
• Study First Submitted QC: 2006-02-21
• Study First Posted: 2006-02-23
• Status Verified: 2007-04
• Study Completion: 2007-04
• Last Update Submitted: 2007-05-08
• Last Update Posted: 2007-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Hypertensive patients with diabetes mellitus
• Hypertensive patients
• Hypertensive patients with renal disease

Exclusion Criteria

• Cardiac, hematologic or hepatic disease
• Renal insufficiency (serum creatinine values> 2 mg/L)
• Hormone-induced hypertension
• Cerebral infarction or hemorrhage
• Other major diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Normalization of high blood pressure	One year

Trial Locations

Locations (1)

Yokohama City University Center Hospital; 🇯🇵 Yokohama, Japan