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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00298129
First Posted: March 1, 2006
Last Update Posted: May 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yokohama City University Medical Center
  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: 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:


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

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: February 28, 2006
First Posted: March 1, 2006
Last Update Posted: May 9, 2007
Last Verified: May 2007

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