A Real World Research: Comparison of Precision and Experience Therapy for Hypertension, Diabetes or Hyperlipidemias (RCG)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes type2; Hyperlipidemias; Hypertension,Essential
• Intervention / Treatment: Diagnostic test: Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseases; Behavioral: Regular follow-up and patient education

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 Type: Interventional
• Enrollment (Actual): 1172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100020
    • Beijng Chao Yang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.

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:

1. Respondents who are not willing to fill in the true and reliable information form for any reason.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: 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.; Other Names: Drug gene chip; Behavioral: Regular follow-up and patient education; The subjects received regular follow-up and patient education.
Active Comparator: 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.	Behavioral: Regular follow-up and patient education; The subjects received regular follow-up and patient education.
No Intervention: Observation group; The subjects did not accept any intervention, including follow-up, especially regular evaluation of efficacy and adverse reactions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of systolic pressure	Change of systolic blood pressure from baseline	3 months
change of diastolic pressure	Change of diastolic blood pressure from baseline	3 months
change of glycosylated hemoglobin	Change of glycosylated hemoglobin from baseline	3 months
change of fasting blood glucose	Change of fasting blood glucose from baseline	3 months
change of total cholesterol	Change of total cholesterol from baseline	3 months
change of low density lipoprotein cholesterol	Change of low density lipoprotein cholesterol from baseline	3 months
change of triglyceride	Change of triglyceride from baseline	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance rate of blood pressure	Change of the compliance rate of blood pressure from baseline	12 months
Compliance rate of glycosylated hemoglobin	Change of the compliance rate of glycosylated hemoglobin from baseline	12 months
Compliance rate of low density lipoprotein cholesterol	Change of the compliance rate of low density lipoprotein cholesterol from baseline	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the total costs of hypertension treatment	Change of annualized cost of hypertension treatment from baseline.	12 months
Change of the medicine costs of hypertension treatment	Change of annualized cost of hypertension treatment from baseline.	12 months
Change of the total costs of diabetes treatment	Change of annualized cost of diabetes treatment from baseline.	12 months
change of the medicine costs of diabetes treatment	Change of annualized cost of diabetes treatment from baseline.	12 months
Change of the total costs of hyperlipidemia treatment	Change of annualized cost of hyperlipidemia treatment from baseline.	12 months
Change of the medicine costs of hyperlipidemia treatment	Change of annualized cost of hyperlipidemia treatment from baseline.	12 months
Medication compliance	Change of the score of Morisky Medication Adherence Scale(MMAS-8) from baseline.	12 months
Health self assessment	Change of the score of EuroQol five dimensions questionnaire from baseline.	12 months

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Collaborators: China development research foundation
• Investigators: Principal Investigator: Lihong Liu, Doctor, Beijing Chao Yang Hospital; Principal Investigator: Yue Qiu, Doctor, China development research foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Anticipated): December 20, 2023
• Study Completion (Anticipated): January 20, 2025

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Lipid Metabolism Disorders; Dyslipidemias; Hypertension; Diabetes Mellitus, Type 2; Essential Hypertension; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: 2020-1-21-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No