Diastolic DysfunctionNCT03177408
Impact of HMGB1 on Diastolic Dysfunction in Hypertensive Patients
An observational study of Diastolic Dysfunction and Hypertension, run by Jing Li.
Trial summary
This study evaluated the association between HMGB1 and diastolic dysfunction in hypertensive patients. HMGB1 level were tested in all patients, and diastolic function determined by echocardiographic. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diastolic Dysfunction, Hypertension, Inflammation
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2017to 31 Dec 2017
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study sample is recruited from the patients examined in the physical examination center of our hospital.
Who may be able to join
- All of the hypertensive patients in both diastolic dysfunction and control groups were either newly diagnosed or were aware of hypertension without using any pharmacotherapy.
- -
Who cannot join
- Individuals already under treatment for hypertension were not include.
- -
About this study
This study evaluated the association between HMGB1 and diastolic dysfunction in hypertensive patients. HMGB1 level were tested in all patients, and diastolic function determined by echocardiographic.
- Conditions
- Diastolic Dysfunction, Hypertension, Inflammation
- Keywords
- Diastolic Dysfunction, Hypertension, HMGB1
- Medical subject headings
- Hypertension, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of HMGB1 levels between hypertensive patients with and without diastolic dysfunction
Blood samples of all individuals are collected on the day of admission and HMGB1 levels are tested. Echocardiographic assessment is performed with echocardiography device by using 2.5-3.5 Mega Hertz(MHz) transducer in the lateral decubitis position.
Measured: on the day of admission
Secondary outcomes (1)
Differences of HMGB1 levels between grades of diastolic dysfunction
Blood samples of all individuals are collected on the day of admission and HMGB1 levels are tested. Echocardiographic assessment is performed with echocardiography device by using 2.5-3.5 Mega Hertz(MHz) transducer in the lateral decubitis position.
Measured: on the day of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start15 Aug 2017 (estimated)
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic DysfunctionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing Li, Affiliated Hospital of Hebei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177408
- Sponsor's protocol ID
- 2017032901
- Status last verified
- Jun 2017
- First submitted
- 16 Apr 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of HMGB1 on Diastolic Dysfunction in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT03177408
- Acronym / sponsor ID
- 2017032901
- Conditions
- Diastolic Dysfunction, Hypertension, Inflammation
- Keywords
- Diastolic Dysfunction, Hypertension, HMGB1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jing LiUniversity, hospital or other
- Study start
- 15 Aug 2017 (estimated)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 6 Jun 2017 (actual)
- 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.
This study evaluated the association between HMGB1 and diastolic dysfunction in hypertensive patients. HMGB1 level were tested in all patients, and diastolic function determined by echocardiographic.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study sample is recruited from the patients examined in the physical examination center of our hospital.
Key inclusion criteria (2 listed)
- All of the hypertensive patients in both diastolic dysfunction and control groups were either newly diagnosed or were aware of hypertension without using any pharmacotherapy.
- -
Key exclusion criteria (2 listed)
- Individuals already under treatment for hypertension were not include.
- -
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
Differences of HMGB1 levels between hypertensive patients with and without diastolic dysfunction
Time frame: on the day of admission
Blood samples of all individuals are collected on the day of admission and HMGB1 levels are tested. Echocardiographic assessment is performed with echocardiography device by using 2.5-3.5 Mega Hertz(MHz) transducer in the lateral decubitis position.
1 secondary outcome
Differences of HMGB1 levels between grades of diastolic dysfunction
Time frame: on the day of admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diastolic Dysfunction and Hypertension, run by Jing Li.
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 2 inclusion and 2 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 6 Jun 2017. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences of HMGB1 levels between hypertensive patients with and without diastolic dysfunction (time frame: on the day of admission). 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 6 Jun 2017.