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NCT Number: NCT00295555

Doxazosin Effects on ABPM 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.

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Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Diabetes Complications Diabetic Nephropathies Endocrine System Diseases Essential Hypertension Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hypertension Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Failure Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yokohama City University Center Hospital

Yokohama, 232-0024, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Effects of doxazosin on morning surge in diabetic patients

Drug

Primary outcomes

  1. Normalization of high blood pressure

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Yokohama City University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2007
First posted
Feb 23, 2006
Registry last updated
May 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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