Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy - Full Text View

Sponsor:	Yokohama City University Medical Center
Information provided by:	Yokohama City University Medical Center
ClinicalTrials.gov Identifier:	NCT00295555

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 IV

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Kidney Problems High Blood Pressure

Drug Information available for: Doxazosin Doxazosin mesylate

U.S. FDA Resources

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

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:

Yasuda G, Hasegawa K, Kuji T, Ogawa N, Shimura G, Umemura S, Tochikubo O. Effects of doxazosin on ambulatory blood pressure and sympathetic nervous activity in hypertensive Type 2 diabetic patients with overt nephropathy. Diabet Med. 2005 Oct;22(10):1394-400.

Yasuda G, Ando D, Hirawa N, Umemura S, Tochikubo O. Effects of losartan and amlodipine on urinary albumin excretion and ambulatory blood pressure in hypertensive type 2 diabetic patients with overt nephropathy. Diabetes Care. 2005 Aug;28(8):1862-8.

Yasuda G, Hasegawa K, Kuji T, Ogawa N, Shimura G, Umemura S, Tochikubo O. Perindopril effects on ambulatory blood pressure: relation to sympathetic nervous activity in subjects with diabetic nephropathy. Am J Hypertens. 2004 Jan;17(1):14-20.

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:

Diabetes Mellitus
Diabetic Nephropathies
Hypertension
Kidney Diseases
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Vascular Diseases
Cardiovascular Diseases

Doxazosin
Adrenergic Antagonists
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012