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

Beijing Chao Yang Hospital1,172 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

1,172

Conditions

Hypertension,Essential Diabetes type2 Hyperlipidemias

Interventions

Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseasesDIAGNOSTIC_TEST

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 educationBEHAVIORAL

The subjects received regular follow-up and patient education.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 120 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijng Chao Yang Hospital

Beijing, China

Outcomes

Primary Outcomes

change of systolic pressure

Change of systolic blood pressure from baseline

Time frame: 3 months

change of diastolic pressure

Change of diastolic blood pressure from baseline

Time frame: 3 months

change of glycosylated hemoglobin

Change of glycosylated hemoglobin from baseline

Time frame: 3 months

change of fasting blood glucose

Change of fasting blood glucose from baseline

Time frame: 3 months

change of total cholesterol

Change of total cholesterol from baseline

Time frame: 3 months

change of low density lipoprotein cholesterol

Change of low density lipoprotein cholesterol from baseline

Time frame: 3 months

change of triglyceride

Change of triglyceride from baseline

Time frame: 3 months

Secondary Outcomes

Compliance rate of blood pressure

Change of the compliance rate of blood pressure from baseline

Time frame: 12 months

Compliance rate of glycosylated hemoglobin

Change of the compliance rate of glycosylated hemoglobin from baseline

Data from ClinicalTrials.gov

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