Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy

This study has been completed.
Sponsor:
Information provided by:
Yokohama City University Medical Center
ClinicalTrials.gov Identifier:
NCT00295555
First received: February 21, 2006
Last updated: May 8, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Essential Hypertension
Renal Failure
Drug: Effects of doxazosin on morning surge in diabetic patients
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Doxazosin on Ambulatory Blood Pressure and Sympathetic Nervous Activity in Hypertensive Patients With Diabetic Nephropathy

Resource links provided by NLM:


Further study details as provided by Yokohama City University Medical Center:

Primary Outcome Measures:
  • Normalization of high blood pressure [ Time Frame: One year ]

Enrollment: 98
Study Start Date: January 2004
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295555

Locations
Japan
Yokohama City University Center Hospital
Yokohama, Japan, 232-0024
Sponsors and Collaborators
Yokohama City University Medical Center
Investigators
Principal Investigator: Gen Yasuda, MD Yokohama City University Center Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00295555     History of Changes
Other Study ID Numbers: 7332-2
Study First Received: February 21, 2006
Last Updated: May 8, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Yokohama City University Medical Center:
ambulatory blood pressure monitoring
doxazosin
alpha1-adrenergic antagonists
sympathetic nervous activity
diabetic nephropathy
essential hypertension
power spectral analysis
morning surge

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus
Kidney Diseases
Renal Insufficiency
Diabetic Nephropathies
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Doxazosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 15, 2014