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

Capital Medical University

Status: Active, not recruiting

Conditions: Hypertension,Essential; Hyperlipidemias; Diabetes type2

Treatments: Behavioral: Regular follow-up and patient education; Diagnostic Test: Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseases

Study type: Interventional

Funder types: Other

Identifiers

NCT04660630

2020-1-21-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,172 patients

Sex: All

Ages: 55 to 120 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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1,172 participants in 3 patient groups

Precision group

Experimental group

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.

Treatment:

Diagnostic Test: Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseases

Behavioral: Regular follow-up and patient education

Experience group

Active Comparator group

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.

Treatment:

Behavioral: Regular follow-up and patient education

Observation group

No Intervention group

Description:

The subjects did not accept any intervention, including follow-up, especially regular evaluation of efficacy and adverse reactions.