Diabetes MellitusNCT00298129
Autonomic Imbalance and 24-h Blood Pressure Change in Patients With Chronic Renal Disease
An observational study of Diabetes Mellitus and Essential Hypertension, run by Yokohama City University Medical Center at 1 site in Japan.
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). Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Essential Hypertension, Renal Failure
- What is being tested?
- Ambulatory blood pressure monitoring
- Type of treatment
- Medical device
- How many people
- 278 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2004to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hypertensive patients with diabetes mellitus
- Hypertensive patients
- Hypertensive patients with renal disease
- Patients with chronic renal disease
Who cannot join
- Cardiac, hematologic or hepatic disease
- Cerebral infarction or hemorrhage
- Other major diseases.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Ambulatory blood pressure monitoring
- Medical subject headings
- Diabetes Mellitus, Essential Hypertension, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory blood pressure monitoringDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
- Study startFeb 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Natural history
- Time perspective
- Prospective
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yokohama City University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Gen Yasuda, MD, Principal investigator, Yokohama City University Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298129
- Sponsor's protocol ID
- 7332-3
- Status last verified
- May 2007
- First submitted
- 28 Feb 2006
- Last updated
- 9 May 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 7851031
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Imbalance and 24-h Blood Pressure Change in Patients With Chronic Renal Disease
- ClinicalTrials.gov ID
- NCT00298129
- Acronym / sponsor ID
- 7332-3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Yokohama City University Medical CenterUniversity, hospital or other
- Study start
- Feb 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 1 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Natural history
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hypertensive patients with diabetes mellitus
- Hypertensive patients
- Hypertensive patients with renal disease
- Patients with chronic renal disease
Key exclusion criteria (3 listed)
- Cardiac, hematologic or hepatic disease
- Cerebral infarction or hemorrhage
- Other major diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory blood pressure monitoring | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2007.
- Background: PubMed 7851031Yasuda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gen Yasuda, MD principal investigator
Yokohama City University Center Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Essential Hypertension, run by Yokohama City University Medical Center at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2007.