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

NCT ID: NCT00298129

Last Updated: 2007-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

278 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-02-29

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus Essential Hypertension Renal Failure Chronic Nephropathy

Study Design

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Observational Model Type

NATURAL_HISTORY

Study Time Perspective

PROSPECTIVE

Interventions

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Ambulatory blood pressure monitoring

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yokohama City University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Gen Yasuda, MD

Role: PRINCIPAL_INVESTIGATOR

Yokohama City University Center Hospital

Locations

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Yokohama City University Center Hospital

Yokohama, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND
PMID: 7851031 (View on PubMed)

Other Identifiers

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7332-3

Identifier Type: -

Identifier Source: org_study_id