Clinical trial NCT00295555: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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
Lead sponsor: Yokohama City University Medical Center
Sponsor class: OTHER
First posted: 2006-02-23
Enrollment: 98
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Normalization of high blood pressure
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Yokohama City University Center Hospital
Study officials:
affiliation: Yokohama City University Center Hospital
name: Gen Yasuda, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.