Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy

May 8, 2007 updated by: Yokohama City University Medical Center

Effects of Doxazosin on Ambulatory Blood Pressure and Sympathetic Nervous Activity in Hypertensive Patients With Diabetic Nephropathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Yokohama, Japan, 232-0024
        • Yokohama City University Center Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Normalization of high blood pressure
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yokohama City University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

February 21, 2006

First Submitted That Met QC Criteria

February 21, 2006

First Posted (ESTIMATE)

February 23, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 10, 2007

Last Update Submitted That Met QC Criteria

May 8, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7332-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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