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

Hyperlipidemias Clinical Trial

— RCG  

Official title:

Real World Research Based on Genomics: Comparison of Precision and Experience Therapy for Chronic Cardiovascular and Cerebrovascular Diseases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04660630
• Other study ID #: 2020-1-21-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: January 20, 2025

Study information

• Verified date: December 2020
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1172
• Est. completion date: January 20, 2025
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes type2
• Essential Hypertension
• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension
• Hypertension,Essential

Intervention

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.

Behavioral:
• Regular follow-up and patient education
The subjects received regular follow-up and patient education.

Locations

Country	Name	City	State
China	Beijng Chao Yang Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital	China development research foundation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of the total costs of hypertension treatment	Change of annualized cost of hypertension treatment from baseline.	12 months
Other	Change of the medicine costs of hypertension treatment	Change of annualized cost of hypertension treatment from baseline.	12 months
Other	Change of the total costs of diabetes treatment	Change of annualized cost of diabetes treatment from baseline.	12 months
Other	change of the medicine costs of diabetes treatment	Change of annualized cost of diabetes treatment from baseline.	12 months
Other	Change of the total costs of hyperlipidemia treatment	Change of annualized cost of hyperlipidemia treatment from baseline.	12 months
Other	Change of the medicine costs of hyperlipidemia treatment	Change of annualized cost of hyperlipidemia treatment from baseline.	12 months
Other	Medication compliance	Change of the score of Morisky Medication Adherence Scale(MMAS-8) from baseline.	12 months
Other	Health self assessment	Change of the score of EuroQol five dimensions questionnaire from baseline.	12 months
Primary	change of systolic pressure	Change of systolic blood pressure from baseline	3 months
Primary	change of diastolic pressure	Change of diastolic blood pressure from baseline	3 months
Primary	change of glycosylated hemoglobin	Change of glycosylated hemoglobin from baseline	3 months
Primary	change of fasting blood glucose	Change of fasting blood glucose from baseline	3 months
Primary	change of total cholesterol	Change of total cholesterol from baseline	3 months
Primary	change of low density lipoprotein cholesterol	Change of low density lipoprotein cholesterol from baseline	3 months
Primary	change of triglyceride	Change of triglyceride from baseline	3 months
Secondary	Compliance rate of blood pressure	Change of the compliance rate of blood pressure from baseline	12 months
Secondary	Compliance rate of glycosylated hemoglobin	Change of the compliance rate of glycosylated hemoglobin from baseline	12 months
Secondary	Compliance rate of low density lipoprotein cholesterol	Change of the compliance rate of low density lipoprotein cholesterol from baseline	12 months