HypertensionBIOMS-HTNNCT04107584
Prognostic Value of Plasma Biomarkers Among Patients With Hypertension
An observational study of Hypertension, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
Trial summary
Hypertension is the most important risk factor for cardiovascular and cerebrovascular diseases，and also a substantial public health problem. The purpose of the study is to investigate the association between plasma biomarkers and adverse outcomes in patients with hypertension. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to Aug 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospitalized patients with hypertension
Who may be able to join
- >18 years old
- In accordance with the diagnosis of hypertension (BP≥140/90mmHg)
Who cannot join
- The exclusion Criteria for the study program were as follows:
- Pregnancy, history of heart failure or left ventricular ejection fraction less than 40%, myocardial infarction within one month, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting, cerebrovascular disease, severe liver disease, severe chronic renal failure (eGFR less than 30 mL/min/1.73 m2) in the past three months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Yulin Li, PhD, lyllyl_1111@163.com
Jie Du, PhD
About this study
Hypertension is the most important risk factor for cardiovascular and cerebrovascular diseases，and also a substantial public health problem. The purpose of the study is to investigate the association between plasma biomarkers and adverse outcomes in patients with hypertension.
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary mortality of hypertension
The incidence rate of primary mortality of hypertension
Measured: Through study completion, an average of 2 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 2 years
Secondary outcomes of brain
The incidence rate of stroke (include cerebral hemorrhage and cerebral ischemia
Measured: Through study completion, an average of 2 years
Secondary outcomes of kidney
The incidence rate of hypertensive renal injure and end-stage renal disease
Measured: Through study completion, an average of 2 years
Secondary outcomes of eyes
The incidence rate of hypertensive eye injure
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Apr 2017
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Du, PhD, Study director, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107584
- Sponsor's protocol ID
- HTN2019
- Acronym
- BIOMS-HTN
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Plasma Biomarkers Among Patients With Hypertension
- ClinicalTrials.gov ID
- NCT04107584
- Acronym / sponsor ID
- BIOMS-HTN / HTN2019
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel DiseasesUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 27 Sep 2019 (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.
Hypertension is the most important risk factor for cardiovascular and cerebrovascular diseases，and also a substantial public health problem. The purpose of the study is to investigate the association between plasma biomarkers and adverse outcomes in patients with hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with hypertension
Key inclusion criteria (2 listed)
- >18 years old
- In accordance with the diagnosis of hypertension (BP≥140/90mmHg)
Key exclusion criteria (2 listed)
- The exclusion Criteria for the study program were as follows:
- Pregnancy, history of heart failure or left ventricular ejection fraction less than 40%, myocardial infarction within one month, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting, cerebrovascular disease, severe liver disease, severe chronic renal failure (eGFR less than 30 mL/min/1.73 m2) in the past three months.
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 hypertension
Time frame: Through study completion, an average of 2 years
The incidence rate of primary mortality of hypertension
4 secondary outcomes
Secondary outcomes of heart
Time frame: Through study completion, an average of 2 years
Secondary outcomes of brain
Time frame: Through study completion, an average of 2 years
Secondary outcomes of kidney
Time frame: Through study completion, an average of 2 years
Secondary outcomes of eyes
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- 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.
Jie Du, PhD study director
Beijing Anzhen 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 Beijing Institute of Heart, Lung and Blood Vessel 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 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 27 Sep 2019. 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 Yulin Li, PhD (0086-010-64456453, lyllyl_1111@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 hypertension (time frame: Through study completion, an average of 2 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 27 Sep 2019.