Back to resultsA Real World Research: Comparison of Precision and Experience Therapy for Hypertension, Diabetes or Hyperlipidemias (RCG)
Primary Purpose
Hypertension,Essential, Diabetes type2, Hyperlipidemias
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseases
Regular follow-up and patient education
Sponsored by
About this trial
This is an interventional supportive care trial for Hypertension,Essential
Eligibility Criteria
Inclusion Criteria:
- 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:
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.
- Patients who can provide real and reliable information related to drug treatment and efficacy evaluation
Exclusion Criteria:
- 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.
Sites / Locations
- Beijng Chao Yang Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Precision group
Experience group
Observation group
Arm Description
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.
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.
The subjects did not accept any intervention, including follow-up, especially regular evaluation of efficacy and adverse reactions.
Outcomes
Primary Outcome Measures
change of systolic pressure
Change of systolic blood pressure from baseline
change of diastolic pressure
Change of diastolic blood pressure from baseline
change of glycosylated hemoglobin
Change of glycosylated hemoglobin from baseline
change of fasting blood glucose
Change of fasting blood glucose from baseline
change of total cholesterol
Change of total cholesterol from baseline
change of low density lipoprotein cholesterol
Change of low density lipoprotein cholesterol from baseline
change of triglyceride
Change of triglyceride from baseline
Secondary Outcome Measures
Compliance rate of blood pressure
Change of the compliance rate of blood pressure from baseline
Compliance rate of glycosylated hemoglobin
Change of the compliance rate of glycosylated hemoglobin from baseline
Compliance rate of low density lipoprotein cholesterol
Change of the compliance rate of low density lipoprotein cholesterol from baseline
Full Information
NCT ID
NCT04660630
First Posted
November 19, 2020
Last Updated
December 8, 2020
Sponsor
Beijing Chao Yang Hospital
Collaborators
China development research foundation
1. Study Identification
Unique Protocol Identification Number
NCT04660630
Brief Title
A Real World Research: Comparison of Precision and Experience Therapy for Hypertension, Diabetes or Hyperlipidemias
Acronym
RCG
Official Title
Real World Research Based on Genomics: Comparison of Precision and Experience Therapy for Chronic Cardiovascular and Cerebrovascular Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
January 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital
Collaborators
China development research foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential, Diabetes type2, Hyperlipidemias
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Precision group
Arm Type
Experimental
Arm Description
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.
Arm Title
Experience group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Observation group
Arm Type
No Intervention
Arm Description
The subjects did not accept any intervention, including follow-up, especially regular evaluation of efficacy and adverse reactions.
Intervention Type
Diagnostic Test
Intervention Name(s)
Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseases
Other Intervention Name(s)
Drug gene chip
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Regular follow-up and patient education
Intervention Description
The subjects received regular follow-up and patient education.
Primary Outcome Measure Information:
Title
change of systolic pressure
Description
Change of systolic blood pressure from baseline
Time Frame
3 months
Title
change of diastolic pressure
Description
Change of diastolic blood pressure from baseline
Time Frame
3 months
Title
change of glycosylated hemoglobin
Description
Change of glycosylated hemoglobin from baseline
Time Frame
3 months
Title
change of fasting blood glucose
Description
Change of fasting blood glucose from baseline
Time Frame
3 months
Title
change of total cholesterol
Description
Change of total cholesterol from baseline
Time Frame
3 months
Title
change of low density lipoprotein cholesterol
Description
Change of low density lipoprotein cholesterol from baseline
Time Frame
3 months
Title
change of triglyceride
Description
Change of triglyceride from baseline
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Compliance rate of blood pressure
Description
Change of the compliance rate of blood pressure from baseline
Time Frame
12 months
Title
Compliance rate of glycosylated hemoglobin
Description
Change of the compliance rate of glycosylated hemoglobin from baseline
Time Frame
12 months
Title
Compliance rate of low density lipoprotein cholesterol
Description
Change of the compliance rate of low density lipoprotein cholesterol from baseline
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Change of the total costs of hypertension treatment
Description
Change of annualized cost of hypertension treatment from baseline.
Time Frame
12 months
Title
Change of the medicine costs of hypertension treatment
Description
Change of annualized cost of hypertension treatment from baseline.
Time Frame
12 months
Title
Change of the total costs of diabetes treatment
Description
Change of annualized cost of diabetes treatment from baseline.
Time Frame
12 months
Title
change of the medicine costs of diabetes treatment
Description
Change of annualized cost of diabetes treatment from baseline.
Time Frame
12 months
Title
Change of the total costs of hyperlipidemia treatment
Description
Change of annualized cost of hyperlipidemia treatment from baseline.
Time Frame
12 months
Title
Change of the medicine costs of hyperlipidemia treatment
Description
Change of annualized cost of hyperlipidemia treatment from baseline.
Time Frame
12 months
Title
Medication compliance
Description
Change of the score of Morisky Medication Adherence Scale(MMAS-8) from baseline.
Time Frame
12 months
Title
Health self assessment
Description
Change of the score of EuroQol five dimensions questionnaire from baseline.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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:
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.
Patients who can provide real and reliable information related to drug treatment and efficacy evaluation
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lihong Liu, Doctor
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yue Qiu, Doctor
Organizational Affiliation
China development research foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijng Chao Yang Hospital
City
Beijing
ZIP/Postal Code
100020
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Real World Research: Comparison of Precision and Experience Therapy for Hypertension, Diabetes or Hyperlipidemias
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