Cardiovascular DiseaseNCT02315313
The Link Between the Clinical Resting Heart Rate and Sympathetic Overactivation
An observational study of Cardiovascular Disease, run by Ruijin Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cardiovascular disease patient
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group1 | RHR≤60bpm | |
| group2 | RHR 61-70bpm | |
| group3 | RHR 71-80bpm | |
| group4 | RHR >80bpm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of HRV, BPV, LF/HF between each groups
The difference on mean sympathetic overactivation related indexes such as HRV, BPV, LF/HF between groups
Measured: 1min HR measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jiguang, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315313
- Sponsor's protocol ID
- ESR-14-10153
- Status last verified
- Dec 2014
- First submitted
- 2 Dec 2014
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Link Between the Clinical Resting Heart Rate and Sympathetic Overactivation
- ClinicalTrials.gov ID
- NCT02315313
- Acronym / sponsor ID
- ESR-14-10153
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 11 Dec 2014 (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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group1 | – | –RHR≤60bpm |
| group2 | – | –RHR 61-70bpm |
| group3 | – | –RHR 71-80bpm |
| group4 | – | –RHR >80bpm |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cardiovascular disease patient
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Ruijin Hospital.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiguang Wang, PHD (13764189476, wangjiguang2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of HRV, BPV, LF/HF between each groups (time frame: 1min HR measure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2014.