Autonomic Imbalance and 24-h Blood Pressure Change in Patients With Chronic Renal Disease

This study has been completed.

First Received: February 28, 2006 Last Updated: May 8, 2007 History of Changes

Sponsored by:	Yokohama City University Medical Center
Information provided by:	Yokohama City University Medical Center
ClinicalTrials.gov Identifier:	NCT00298129

Purpose

Many patients with chronic renal disease show a loss of the nocturnal decline of blood pressure (non-dipper). However, the mechanism is not yet fully understood. We evaluate 24-hour blood pressure in patients with chronic renal disease using an ambulatory blood pressure monitoring device (A & D TM2425). We also analyze the power spectrum of heart rate variability as an index of autonomic cardiovascular modulation using the same device.

Condition	Intervention
Diabetes Mellitus Essential Hypertension Renal Failure Chronic Nephropathy	Device: Ambulatory blood pressure monitoring

MedlinePlus related topics: Diabetes High Blood Pressure Kidney Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Convenience Sample, Prospective Study
Official Title:	Autonomic Imbalance and 24-h Blood Pressure Change in Patients With Chronic Renal Disease

Further study details as provided by Yokohama City University Medical Center:

Enrollment:	278
Study Start Date:	February 2004
Study Completion Date:	December 2006

Detailed Description:

The ratio of lower frequency (LF) and higher frequency (HF) heart rate rhythmic oscillations is expressed as an index of sympathovagal balance.

Patients with chronic renal disease participate in the study. Blood pressure and power spectrum of heart rate variability for 24 hours are measured when they receive no medication for at least 1 week. The mean waking and sleeping time systolic and diastolic blood pressure are calculated. LF/HF ratios in the chronic renal disease are evaluated to calculate the waking/sleeping ratio for LF/HF.

Eligibility

Ages Eligible for Study:	20 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Hypertensive patients with diabetes mellitus
Hypertensive patients
Hypertensive patients with renal disease
Patients with chronic renal disease

Exclusion Criteria:

Cardiac, hematologic or hepatic disease
Cerebral infarction or hemorrhage
Other major diseases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298129

Locations

Japan
Yokohama City University Center Hospital
Yokohama, Japan, 232-0024

Sponsors and Collaborators

Yokohama City University Medical Center

Investigators

Principal Investigator:	Gen Yasuda, MD	Yokohama City University Center Hospital
Principal Investigator:	Gen Yasuda, MD	Yokohama City University Center Hospital
Principal Investigator:	Gen Yasuda, MD	Yokohama City University Center Hospital

More Information

Publications:

Yasuda G, Nagasawa T, Umemura S, Shionoiri H, Ishii M. The impaired control of plasma renin activity in hypertensive patients with end-stage renal disease due to chronic glomerulonephritis. Clin Nephrol. 1994 Nov;42(5):300-8.

Study ID Numbers:	7332-3
Study First Received:	February 28, 2006
Last Updated:	May 8, 2007
ClinicalTrials.gov Identifier:	NCT00298129 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Renal Insufficiency
Essential Hypertension
Metabolic Diseases
Kidney Failure, Chronic
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Urologic Diseases

Renal Insufficiency, Chronic
Endocrinopathy
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Disorder
Kidney Failure
Hypertension

Additional relevant MeSH terms:

Renal Insufficiency
Metabolic Diseases
Diabetes Mellitus
Kidney Failure, Chronic
Vascular Diseases
Endocrine System Diseases
Urologic Diseases

Renal Insufficiency, Chronic
Cardiovascular Diseases
Kidney Diseases
Glucose Metabolism Disorders
Hypertension
Kidney Failure

ClinicalTrials.gov processed this record on May 06, 2009