HypertensionCHESSNCT02819674
The Chinese Early-onset Hypertension Study (CHESS)
An observational study of Hypertension, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Hypertension (HTN) is the most important cardiovascular risk factor which is responsible for 50% of cardiovascular morbidity and mortality, and also a substantial public health problem affecting approximately 1/4 of the adult population in industrialized societies and over 1 billion people worldwide. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Between October 2012 and December 2020(anticipated) recruited from multiple centers in China, in accordance with the diagnosis of hypertension, and less than 40 years when diagnosed
Who may be able to join
- In accordance with the diagnosis of hypertension (BP≥140/90mmHg), and less than 40 years when diagnosed
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai hospital
Beijing, Beijing Municipality, 100037
Lei Song, MD.& PhD., 86-13810532620, clinicalfw@163.com
Lei Song, MD.& PhD., 86-18600197655, lsongqd@yahoo.com
About this study
Hypertension (HTN) is the most important cardiovascular risk factor which is responsible for 50% of cardiovascular morbidity and mortality, and also a substantial public health problem affecting approximately 1/4 of the adult population in industrialized societies and over 1 billion people worldwide. Chronically elevated blood pressure without well control puts people at increased risk of target organ damages, including stroke, myocardial infarction, congestive heart failure, end-stage renal disease, blindness, and death. Especially, these damages are dramatically more severe in the early-onset hypertensive population.
Read the detailed description
In this study, the hypertensive individuals are consecutively recruited from multiple centers, with an early onset age (less than 40 when diagnosed). A complete clinical history (information on history of hypertension, demographic characteristics, personal and family medical history) are collected by a trained staff using a standardized questionnaire on the first day of baseline observation, and physical examination are also collected in a standard procedure. Blood samples are collected after 12-hour overnight fast and biological variables are determined. Genomic DNA is isolated from leukocytes according to a standard procedure. The individuals will receive follow-up in an ordinal system. The investigators will focus on the clinical and genetic features, genotype-phenotype correlations and influencing factors of prognosis in Chinese early-onset hypertension patients.
- Conditions
- Hypertension
- Keywords
- hypertension, early onset, target organ damage
- Medical subject headings
- Hypertension
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 |
|---|---|---|
| early-onset hypertension | early-onset hypertension patients recruited in Chinese multiple centers |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary mortality of early-onset hypertension
the primary mortality of early-onset hypertension
Measured: through study completion, an average of 5 years
Secondary outcomes (4)
secondary outcomes of heart
The incidence rate of left ventricular hypertrophy, myocardial infarction, congestive heart failure, and arrhythmia.
Measured: through study completion, an average of 5 years
secondary outcomes of brain
The incidence rate of stroke (include cerebral hemorrhage and cerebral ischemia)
Measured: through study completion, an average of 5 years
secondary outcomes of kidney
The incidence rate of hypertensive renal injure and end-stage renal disease
Measured: through study completion, an average of 5 years
secondary outcomes of eyes
The incidence rate of hypertensive eye injure
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startOct 2012
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lei.Song@NCCD, China National Center for Cardiovascular Diseases
- Investigators
- Lei Song, MD.& PhD., Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819674
- Sponsor's protocol ID
- CEHS-2016
- Acronym
- CHESS
- Status last verified
- Jan 2018
- First submitted
- 20 May 2016
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chinese Early-onset Hypertension Study (CHESS)
- ClinicalTrials.gov ID
- NCT02819674
- Acronym / sponsor ID
- CHESS / CEHS-2016
- Conditions
- Hypertension
- Keywords
- hypertension, early onset, target organ damage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- Oct 2012
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Jun 2016 (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.
Hypertension (HTN) is the most important cardiovascular risk factor which is responsible for 50% of cardiovascular morbidity and mortality, and also a substantial public health problem affecting approximately 1/4 of the adult population in industrialized societies and over 1 billion people worldwide. Chronically elevated blood pressure without well control puts people at increased risk of target organ damages, including stroke, myocardial infarction, congestive heart failure, end-stage renal disease, blindness, and death. Especially, these damages are dramatically more severe in the early-onset hypertensive population.
Detailed description
In this study, the hypertensive individuals are consecutively recruited from multiple centers, with an early onset age (less than 40 when diagnosed). A complete clinical history (information on history of hypertension, demographic characteristics, personal and family medical history) are collected by a trained staff using a standardized questionnaire on the first day of baseline observation, and physical examination are also collected in a standard procedure. Blood samples are collected after 12-hour overnight fast and biological variables are determined. Genomic DNA is isolated from leukocytes according to a standard procedure. The individuals will receive follow-up in an ordinal system. The investigators will focus on the clinical and genetic features, genotype-phenotype correlations and influencing factors of prognosis in Chinese early-onset hypertension patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| early-onset hypertension | – | –early-onset hypertension patients recruited in Chinese multiple centers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Between October 2012 and December 2020(anticipated) recruited from multiple centers in China, in accordance with the diagnosis of hypertension, and less than 40 years when diagnosed
Key inclusion criteria (1 listed)
- In accordance with the diagnosis of hypertension (BP≥140/90mmHg), and less than 40 years when diagnosed
Key exclusion criteria (1 listed)
- -
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
primary mortality of early-onset hypertension
Time frame: through study completion, an average of 5 years
the primary mortality of early-onset hypertension
4 secondary outcomes
secondary outcomes of heart
Time frame: through study completion, an average of 5 years
secondary outcomes of brain
Time frame: through study completion, an average of 5 years
secondary outcomes of kidney
Time frame: through study completion, an average of 5 years
secondary outcomes of eyes
Time frame: through study completion, an average of 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Lei Song, MD.& PhD. principal investigator
Chinese Academy of Medical Sciences, Fuwai 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 Hypertension, run by China National Center for Cardiovascular Diseases at 1 site in China.
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 1 inclusion and 1 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 9 Jan 2018. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Song, MD.& PhD. (86-13810532620, clinicalfw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary mortality of early-onset hypertension (time frame: through study completion, an average of 5 years). 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 9 Jan 2018.