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Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy

Primary Purpose

Diabetes Mellitus, Essential Hypertension, Renal Failure

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Effects of doxazosin on morning surge in diabetic patients

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring ambulatory blood pressure monitoring, doxazosin, alpha1-adrenergic antagonists, sympathetic nervous activity, diabetic nephropathy, essential hypertension, power spectral analysis, morning surge

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yokohama City University Center Hospital

Outcomes

Primary Outcome Measures

Normalization of high blood pressure

Secondary Outcome Measures

Full Information

NCT ID

NCT00295555

First Posted

February 21, 2006

Last Updated

May 8, 2007

Sponsor

Yokohama City University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00295555

Brief Title

Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Yokohama City University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Essential Hypertension, Renal Failure

Keywords

ambulatory blood pressure monitoring, doxazosin, alpha1-adrenergic antagonists, sympathetic nervous activity, diabetic nephropathy, essential hypertension, power spectral analysis, morning surge

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Effects of doxazosin on morning surge in diabetic patients

Primary Outcome Measure Information:

Title

Normalization of high blood pressure

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gen Yasuda, MD

Organizational Affiliation

Yokohama City University Center Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yokohama City University Center Hospital

City

Yokohama

ZIP/Postal Code

232-0024

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

16176202

Citation

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.

Results Reference

background

PubMed Identifier

16043724

Citation

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.

Results Reference

background

PubMed Identifier

14700506

Citation

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.

Results Reference

background

PubMed Identifier

24866870

Citation

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.

Results Reference

derived

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Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy

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