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...
Date First Received: February 21, 2006
Last Updated: May 8, 2007
Verified by: Yokohama City University Medical Center, April 2007
Clinical Trial Phase: Phase 4 | Start Date: January 2004
Overall Status: Completed
Estimated Enrollment: 98
Brief Summary
Official Title: “Effects of Doxazosin on Ambulatory Blood Pressure and Sympathetic Nervous Activity in Hypertensive Patients With Diabetic Nephropathy”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Effects of doxazosin on morning surge in diabetic patients
Outcome Measures for this Clinical Trial
Primary Measures
- Normalization of high blood pressure
- Time Frame: One year
- Time Frame: One year
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: 79 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Yokohama City University Medical Center
Overall Clinical Trial Officials and Contacts
Gen Yasuda, MD Principal Investigator Yokohama City University Center Hospital
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00295555
Study ID Number: 7332-2
ClinicalTrials.gov Identifier: NCT00295555
Health Authority: Japan: Ministry of Health, Labor and Welfare
Clinical Trials Authorship and Review
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