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

This study has been completed.
Sponsor:
Information provided by:
Yokohama City University Medical Center
ClinicalTrials.gov Identifier:
NCT00298129
First received: February 28, 2006
Last updated: May 8, 2007
Last verified: May 2007
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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
  More Information

Publications:

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

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013