Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy
Information source: Yokohama City University Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus; Essential Hypertension; Renal Failure
Intervention: Effects of doxazosin on morning surge in diabetic patients (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Yokohama City University Medical Center Official(s) and/or principal investigator(s):
Gen Yasuda, MD, Principal Investigator, Affiliation: Yokohama City University Center Hospital
Gen Yasuda, MD, Principal Investigator, Affiliation: Yokohama City University Center Hospital
Summary
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.
Clinical Details
Official title: Effects of Doxazosin on Ambulatory Blood Pressure and Sympathetic Nervous Activity in Hypertensive Patients With Diabetic Nephropathy
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Normalization of high blood pressure
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
Minimum age: 20 Years.
Maximum age: 79 Years.
Gender(s): Both.
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
Locations and Contacts
Yokohama City University Center Hospital, Yokohama 232-0024, Japan
Additional Information
Related 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.
Starting date: January 2004
Ending date: April 2007
Last updated: May 8, 2007
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