Monogenic HypertensionNCT03012295
Genetic Testing of Monogenic Hypertension in Chinese Population
An observational study of Monogenic Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Monogenic hypertension, which follows the rules of Mendel's genetic law, is one of the most important causes of hypertension. Generally, patients occur hypertension in early age, have family history, and often manifest severe hypertension or refractory hypertension. Read more about this study
- Who is it for?
- Ages Up to 50 years
- Conditions the study is for
- Monogenic Hypertension
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Mar 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 Up to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: High blood pressure outpatients and inpatients from national multi-hypertension center.
Who may be able to join
- hypertension patients meet one of the following criteria
- Beginning age of hypertension: <35 years (regardless of family history of hypertension);
- refractory hypertension (blood pressure is difficult to control): triple antihypertensive drugs treatment for 1 months, 3 times of non-continuous high blood pressure in consulting room (SBP ≥140mmHg and/or DBP≥90mmHg);
- patients suspected of secondary hypertension, meeting one of the following criteria
- pheochromocytoma or Cushing syndrome;
- hypertension with hypokalemia;
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- hypertension with hyperkalemia;
- hypertension with special body shape, such as central obesity, moon face, acne etc..
- adrenal tumor;
Who cannot join
- renal parenchymal / renovascular hypertension
- patients exceed age of 50, and with coronary heart disease and arteriosclerosis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
CIFuwaiHospital
Beijing
Ling Jin, Ph.D., jinling@fuwaihospital.org
About this study
Monogenic hypertension, which follows the rules of Mendel's genetic law, is one of the most important causes of hypertension. Generally, patients occur hypertension in early age, have family history, and often manifest severe hypertension or refractory hypertension. At present, only a few hypertension centers of hospitals in China will help clinically difficult diagnosis hypertensive patients to test some selective genes, while most of other hospitals still perform diagnosis based on biochemical examination and clinical symptoms. Therefore, in order to provide better guidance for the diagnosis and treatment for hypertensive patients, this project aims to develop a single gene detection panel for genetic hypertension, so as to provide new diagnostic technology for early intervention, prevention and treatment of hypertension in clinics.
- Conditions
- Monogenic Hypertension
- Keywords
- Genetic Testing, Chinese Population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
number of genetic variants in Monogenic Hypertension patients as assessed by specific gene panel
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monogenic HypertensionStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Cai, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012295
- Sponsor's protocol ID
- HYP-1000
- Status last verified
- Jan 2017
- First submitted
- 3 Jan 2017
- Last updated
- 6 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Testing of Monogenic Hypertension in Chinese Population
- ClinicalTrials.gov ID
- NCT03012295
- Acronym / sponsor ID
- HYP-1000
- Conditions
- Monogenic Hypertension
- Keywords
- Genetic Testing, Chinese Population
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Mar 2017 (estimated)
- First posted
- 6 Jan 2017 (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.
Monogenic hypertension, which follows the rules of Mendel's genetic law, is one of the most important causes of hypertension. Generally, patients occur hypertension in early age, have family history, and often manifest severe hypertension or refractory hypertension. At present, only a few hypertension centers of hospitals in China will help clinically difficult diagnosis hypertensive patients to test some selective genes, while most of other hospitals still perform diagnosis based on biochemical examination and clinical symptoms. Therefore, in order to provide better guidance for the diagnosis and treatment for hypertensive patients, this project aims to develop a single gene detection panel for genetic hypertension, so as to provide new diagnostic technology for early intervention, prevention and treatment of hypertension in clinics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- High blood pressure outpatients and inpatients from national multi-hypertension center.
Key inclusion criteria (9 listed)
- hypertension patients meet one of the following criteria
- patients suspected of secondary hypertension, meeting one of the following criteria
Key exclusion criteria (2 listed)
- renal parenchymal / renovascular hypertension
- patients exceed age of 50, and with coronary heart disease and arteriosclerosis
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 |
|---|---|---|
| Other | – |
Primary outcome
number of genetic variants in Monogenic Hypertension patients as assessed by specific gene panel
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
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.
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 Monogenic Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital 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 9 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 Jan 2017. 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 Jun Cai, MD,Ph.D. (+86-010-88322161, caijun@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of genetic variants in Monogenic Hypertension patients as assessed by specific gene panel (time frame: one year). 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 Jan 2017.