- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02315313
The Link Between the Clinical Resting Heart Rate and Sympathetic Overactivation
December 8, 2014 updated by: Wang Jiguang, Ruijin Hospital
It is a retrospective study with no products limitation to investigate the link between clinical resting HR and SOA.
Use HR≤60bpm as control group, compare other three groups with the control group and find out the correlation between HR and SOA indexes.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
cardiovascular disease patient
Description
Inclusion Criteria:
- Provision of subject informed written or oral consent
- Female and male aged≥ 20 to ≤ 80 years;
- Records on mean clinical heart rate and SOA indexes were available.
Exclusion Criteria:
- Participation in another clinical study with an investigational product during the last 6 months;
- Drug intervention on heart rate 1 month prior to the inclusion;
- Patients with missing data in the database from the Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
|
group1
RHR≤60bpm
|
|
group2
RHR 61-70bpm
|
|
group3
RHR 71-80bpm
|
|
group4
RHR >80bpm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The difference of HRV, BPV, LF/HF between each groups
Time Frame: 1min HR measure
|
The difference on mean sympathetic overactivation related indexes such as HRV, BPV, LF/HF between groups
|
1min HR measure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
December 2, 2014
First Submitted That Met QC Criteria
December 8, 2014
First Posted (Estimate)
December 11, 2014
Study Record Updates
Last Update Posted (Estimate)
December 11, 2014
Last Update Submitted That Met QC Criteria
December 8, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESR-14-10153
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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