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Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy

NCT ID: NCT00295555

Last Updated: 2007-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus Essential Hypertension Renal Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Effects of doxazosin on morning surge in diabetic patients

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yokohama City University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Gen Yasuda, MD

Role: PRINCIPAL_INVESTIGATOR

Yokohama City University Center Hospital

Locations

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Yokohama City University Center Hospital

Yokohama, , Japan

Site Status

Countries

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Japan

References

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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. doi: 10.1111/j.1464-5491.2005.01636.x.

Reference Type BACKGROUND
PMID: 16176202 (View on PubMed)

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. doi: 10.2337/diacare.28.8.1862.

Reference Type BACKGROUND
PMID: 16043724 (View on PubMed)

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. doi: 10.1016/j.amjhyper.2003.08.005.

Reference Type BACKGROUND
PMID: 14700506 (View on PubMed)

Yasuda G, Saka S, Ando D, Hirawa N. Effects of doxazosin as the third agent on morning hypertension and position-related blood pressure changes in diabetic patients with chronic kidney disease. Clin Exp Hypertens. 2015;37(1):75-81. doi: 10.3109/10641963.2014.913599. Epub 2014 May 27.

Reference Type DERIVED
PMID: 24866870 (View on PubMed)

Other Identifiers

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7332-2

Identifier Type: -

Identifier Source: org_study_id