Hypertension,EssentialRCGNCT04660630
A Real World Research: Comparison of Precision and Experience Therapy for Hypertension, Diabetes or Hyperlipidemias
A study testing Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseases and Regular follow-up and patient education in people with Hypertension,Essential and Diabetes type2, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effectiveness, safety and health economics of precise drug use strategies based on pharmacogenomics compared with traditional drug use strategies for cardiovascular related chronic diseases. Read more about this study
- Who is it for?
- Ages 55 to 120 years
- Conditions the study is for
- Hypertension,Essential, Diabetes type2, Hyperlipidemias
- What is being tested?
- Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseases and Regular follow-up and patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,172 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2020to 20 Jan 2025
- Phase
- Interventional
- 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 55 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They are 55 years old or above, with no gender restriction. They are permanent residents of Da-jie town and Jiu-zhi Township in Da-ming County.
- Patients who meet one of the following:
- Hypertension project group:
- Primary hypertension was definitely diagnosed, systolic blood pressure ≥ 140 millimeter of mercury, diastolic blood pressure ≥ 90 millimeter of mercury, or both after drug treatment.
- B.Type 2 Diabetes project group:
- Patients with type 2 diabetes mellitus (non insulin dependent diabetes mellitus) who were diagnosed as type 2 diabetes mellitus (NIDDM) and had HbA1c ≥ 7.0% after drug treatment before enrollment.
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- C.Hyperlipidemia project group:
- Those who were diagnosed as hyperlipidemia and were treated with or without medication before enrollment.
- Patients who can provide real and reliable information related to drug treatment and efficacy evaluation
Who cannot join
- Respondents who are not willing to fill in the true and reliable information form for any reason.
- Patients with infectious diseases or serious life-threatening diseases such as malignant tumors.
- Patients with severe liver and kidney function damage, affecting the choice of treatment drugs.
- Patients with incomplete data related to study evaluation such as any of following:
- A.The clinical data did not include systolic blood pressure, diastolic blood pressure, heart rate, glycosylated hemoglobin, fasting blood glucose, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride core efficacy evaluation indicators.
- B.The data related to adverse reactions required by clinical research can not be collected, including but not limited to the related drugs with adverse reactions, adverse reaction performance, time correlation, whether to stop suspicious drugs, and whether to stimulate adverse reactions by re-medication.
- C.The information of medication compliance score and quality of life score could not be provided for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real World Research Based on Genomics: Comparison of Precision and Experience Therapy for Chronic Cardiovascular and Cerebrovascular Diseases
The purpose of this study is to evaluate the effectiveness, safety and health economics of precise drug use strategies based on pharmacogenomics compared with traditional drug use strategies for cardiovascular related chronic diseases.
Read the detailed description
This study is a randomized controlled, single blind, multicenter clinical study. Beijing Chaoyang Hospital is the team leader, and director Liu Lihong is the project leader. The sub center is Daming County Street Town Health Center and Daming County Jiuzhi township health center. The team leader is responsible for the formulation, implementation and coordination of the research plan, and each sub center is responsible for the implementation of the specific study, patient management and research information feedback.
Three project groups were set up in this study: primary hypertension, type 2 diabetes and hyperlipidemia. In each group, the control group and the experimental group were set up, and the patients in two pilot towns of Daming County were selected by cluster stratified random sampling. The control group received the treatment of local researchers according to the traditional medication strategy. The patients in the experimental group were treated with the drug regimen formulated by local researchers according to the results of their pharmacogenomic test reports. The subjects were single blind.
- Conditions
- Hypertension,Essential, Diabetes type2, Hyperlipidemias
- Being tested
- Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseases, Regular follow-up and patient education
- Medical subject headings
- Essential Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseasesDiagnostic test
Also called Drug gene chip
According to the results of drug gene chip detection, we combined with the clinical characteristics of the patient to choose more suitable cardiovascular and cerebrovascular treatment drugs.
Regular follow-up and patient educationBehavioural
The subjects received regular follow-up and patient education.
| Study group | Role | What they receive |
|---|---|---|
| Precision group | Experimental | The subjects were tested for gene, and the corresponding therapeutic drugs were selected according to the results of gene detection. Regular follow-up was conducted according to the study design to evaluate the efficacy and adverse reactions. Receives: Diagnostic Test: Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseases; Behavioral: Regular follow-up and patient education |
| Experience group | Active comparator | The subjects were treated with drugs selected by doctors according to their experience. Follow up was performed at the same frequency as the precision group to evaluate the efficacy and adverse reactions. Receives: Behavioral: Regular follow-up and patient education |
| Observation group | No intervention | The subjects did not accept any intervention, including follow-up, especially regular evaluation of efficacy and adverse reactions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of systolic pressure
Change of systolic blood pressure from baseline
Measured: 3 months
change of diastolic pressure
Change of diastolic blood pressure from baseline
Measured: 3 months
change of glycosylated hemoglobin
Change of glycosylated hemoglobin from baseline
Measured: 3 months
change of fasting blood glucose
Change of fasting blood glucose from baseline
Measured: 3 months
change of total cholesterol
Change of total cholesterol from baseline
Measured: 3 months
change of low density lipoprotein cholesterol
Change of low density lipoprotein cholesterol from baseline
Measured: 3 months
change of triglyceride
Change of triglyceride from baseline
Measured: 3 months
Secondary outcomes (3)
Compliance rate of blood pressure
Change of the compliance rate of blood pressure from baseline
Measured: 12 months
Compliance rate of glycosylated hemoglobin
Change of the compliance rate of glycosylated hemoglobin from baseline
Measured: 12 months
Compliance rate of low density lipoprotein cholesterol
Change of the compliance rate of low density lipoprotein cholesterol from baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start21 Jan 2020
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China development research foundation
- Responsible party
- Principal investigator, Lihong Liu, Beijing Chao Yang Hospital
- Investigators
- Lihong Liu, Doctor, Principal investigator, Beijing Chao Yang HospitalYue Qiu, Doctor, Principal investigator, China development research foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660630
- Sponsor's protocol ID
- 2020-1-21-1
- Acronym
- RCG
- Status last verified
- Dec 2020
- First submitted
- 19 Nov 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Research Based on Genomics: Comparison of Precision and Experience Therapy for Chronic Cardiovascular and Cerebrovascular Diseases
- ClinicalTrials.gov ID
- NCT04660630
- Acronym / sponsor ID
- RCG / 2020-1-21-1
- Conditions
- Hypertension,Essential, Diabetes type2, Hyperlipidemias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,172 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- China development research foundation
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 9 Dec 2020 (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.
The purpose of this study is to evaluate the effectiveness, safety and health economics of precise drug use strategies based on pharmacogenomics compared with traditional drug use strategies for cardiovascular related chronic diseases.
Detailed description
This study is a randomized controlled, single blind, multicenter clinical study. Beijing Chaoyang Hospital is the team leader, and director Liu Lihong is the project leader. The sub center is Daming County Street Town Health Center and Daming County Jiuzhi township health center. The team leader is responsible for the formulation, implementation and coordination of the research plan, and each sub center is responsible for the implementation of the specific study, patient management and research information feedback.
Three project groups were set up in this study: primary hypertension, type 2 diabetes and hyperlipidemia. In each group, the control group and the experimental group were set up, and the patients in two pilot towns of Daming County were selected by cluster stratified random sampling. The control group received the treatment of local researchers according to the traditional medication strategy. The patients in the experimental group were treated with the drug regimen formulated by local researchers according to the results of their pharmacogenomic test reports. The subjects were single blind.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Precision group | Experimental | Diagnostic Test: Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseases, Behavioral: Regular follow-up and patient educationThe subjects were tested for gene, and the corresponding therapeutic drugs were selected according to the results of gene detection. Regular follow-up was conducted according to the study design to evaluate the efficacy and adverse reactions. |
| Experience group | Active comparator | Behavioral: Regular follow-up and patient educationThe subjects were treated with drugs selected by doctors according to their experience. Follow up was performed at the same frequency as the precision group to evaluate the efficacy and adverse reactions. |
| Observation group | No intervention | –The subjects did not accept any intervention, including follow-up, especially regular evaluation of efficacy and adverse reactions. |
Who may qualify
- Ages
- 55 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- They are 55 years old or above, with no gender restriction. They are permanent residents of Da-jie town and Jiu-zhi Township in Da-ming County.
- Patients who meet one of the following:
- Primary hypertension was definitely diagnosed, systolic blood pressure ≥ 140 millimeter of mercury, diastolic blood pressure ≥ 90 millimeter of mercury, or both after drug treatment.
- Patients with type 2 diabetes mellitus (non insulin dependent diabetes mellitus) who were diagnosed as type 2 diabetes mellitus (NIDDM) and had HbA1c ≥ 7.0% after drug treatment before enrollment.
- Those who were diagnosed as hyperlipidemia and were treated with or without medication before enrollment.
Key exclusion criteria (7 listed)
- Respondents who are not willing to fill in the true and reliable information form for any reason.
- Patients with infectious diseases or serious life-threatening diseases such as malignant tumors.
- Patients with severe liver and kidney function damage, affecting the choice of treatment drugs.
- Patients with incomplete data related to study evaluation such as any of following:
- A.The clinical data did not include systolic blood pressure, diastolic blood pressure, heart rate, glycosylated hemoglobin, fasting blood glucose, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride core efficacy evaluation indicators.
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 |
|---|---|---|
| Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseasesAlso: Drug gene chipAccording to the results of drug gene chip detection, we combined with the clinical characteristics of the patient to choose more suitable cardiovascular and cerebrovascular treatment drugs. | Diagnostic test | Precision group |
| Regular follow-up and patient educationThe subjects received regular follow-up and patient education. | Behavioural | Experience group, Precision group |
Primary outcome
change of systolic pressure
Time frame: 3 months
Change of systolic blood pressure from baseline
change of diastolic pressure
Time frame: 3 months
Change of diastolic blood pressure from baseline
change of glycosylated hemoglobin
Time frame: 3 months
Change of glycosylated hemoglobin from baseline
change of fasting blood glucose
Time frame: 3 months
Change of fasting blood glucose from baseline
change of total cholesterol
Time frame: 3 months
Change of total cholesterol from baseline
change of low density lipoprotein cholesterol
Time frame: 3 months
Change of low density lipoprotein cholesterol from baseline
change of triglyceride
Time frame: 3 months
Change of triglyceride from baseline
3 secondary outcomes
Compliance rate of blood pressure
Time frame: 12 months
Compliance rate of glycosylated hemoglobin
Time frame: 12 months
Compliance rate of low density lipoprotein cholesterol
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
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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.
Lihong Liu, Doctor principal investigator
Beijing Chao Yang Hospital
Yue Qiu, Doctor principal investigator
China development research foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseases and Regular follow-up and patient education in people with Hypertension,Essential and Diabetes type2, run by Beijing Chao Yang 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 7 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 Dec 2020. 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?
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?
change of systolic pressure (time frame: 3 months). The study lists 7 primary outcomes in all. 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 Dec 2020.