Autonomic Imbalance & 24-h Blood Pressure Change in NCT00298129

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00298129
Other study ID #	7332-3
Secondary ID
Status	Completed
Phase	N/A
First received	February 28, 2006
Last updated	May 8, 2007
Start date	February 2004
Est. completion date	December 2006

Study information
Verified date	May 2007
Source	Yokohama City University Medical Center
Contact	n/a
Is FDA regulated	No
Health authority	Japan: Ministry of Health, Labor and Welfare
Study type	Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status	Completed
Enrollment	278
Est. completion date	December 2006
Est. primary completion date
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	Both
Age group	20 Years to 85 Years
Eligibility	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.

Study Design

Observational Model: Natural History, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Device:
• Ambulatory blood pressure monitoring

Locations
Country	Name	City	State
Japan	Yokohama City University Center Hospital	Yokohama

Sponsors *(1)*
Lead Sponsor	Collaborator
Yokohama City University Medical Center

Country where clinical trial is conducted

Japan,

References & Publications (1)

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. — View Citation

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

Clinical Trial Details — Status: Completed

Administrative data

Study information