Autonomic Imbalance and 24-h Blood Pressure Change in Pat... | NCT00298129

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

NCT00298129

Sponsor

Yokohama City University Medical Center

Status

Completed

Last Update Posted

May 9, 2007Estimated

Enrollment

278Actual

Phase

Not provided

Conditions

Diabetes Mellitus
Essential Hypertension
Renal Failure
Chronic Nephropathy

Interventions

Ambulatory blood pressure monitoring

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Feb 28, 2006

First Submission Date that Met QC Criteria

Feb 28, 2006

First Posted Date

Mar 1, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2007

Last Update Posted Date

May 9, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

278Actual

Name	Type	Description	Arm Group Labels	Other Names
Ambulatory blood pressure monitoring	Device

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gen Yasuda, MD	Yokohama City University Center Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yokohama City University Center Hospital		Yokohama		232-0024	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7851031	Background	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.

ID	Term
D003920	Diabetes Mellitus
D000075222	Essential Hypertension
D051437	Renal Insufficiency

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D001795	Blood Pressure Determination
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis