A Real World Research: Comparison of Precision and Experience Therapy for Hypertension, Diabetes or Hyperlipidemias
NCT ID: NCT04660630
Last Updated: 2020-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1172 participants
INTERVENTIONAL
2020-01-21
2025-01-20
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Precision group
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.
Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseases
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 education
The subjects received regular follow-up and patient education.
Experience group
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.
Regular follow-up and patient education
The subjects received regular follow-up and patient education.
Observation group
The subjects did not accept any intervention, including follow-up, especially regular evaluation of efficacy and adverse reactions.
No interventions assigned to this group
Interventions
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Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseases
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 education
The subjects received regular follow-up and patient education.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who meet one of the following:
A. 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.
C.Hyperlipidemia project group:
Those who were diagnosed as hyperlipidemia and were treated with or without medication before enrollment.
3. Patients who can provide real and reliable information related to drug treatment and efficacy evaluation
Exclusion Criteria
2. Patients with infectious diseases or serious life-threatening diseases such as malignant tumors.
3. Patients with severe liver and kidney function damage, affecting the choice of treatment drugs.
4. 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.
55 Years
120 Years
ALL
No
Sponsors
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China development research foundation
UNKNOWN
Beijing Chao Yang Hospital
OTHER
Responsible Party
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Lihong Liu
Professor
Principal Investigators
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Lihong Liu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Chao Yang Hospital
Yue Qiu, Doctor
Role: PRINCIPAL_INVESTIGATOR
China development research foundation
Locations
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Beijng Chao Yang Hospital
Beijing, , China
Countries
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Other Identifiers
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2020-1-21-1
Identifier Type: -
Identifier Source: org_study_id