Clinical trial NCT04660630: A Real World Research: Comparison of Precision and Experience Therapy for Hypertension, Diabetes or Hyperlipidemias
Official title: Real World Research Based on Genomics: Comparison of Precision and Experience Therapy for Chronic Cardiovascular and Cerebrovascular Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension,Essential
Diabetes type2
Hyperlipidemias
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: China development research foundation
First posted: 2020-12-09
Enrollment: 1172
Sex: ALL
Minimum age (years): 55
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change of systolic pressure
timeFrame: 3 months
measure: change of diastolic pressure
timeFrame: 3 months
measure: change of glycosylated hemoglobin
timeFrame: 3 months
measure: change of fasting blood glucose
timeFrame: 3 months
measure: change of total cholesterol
timeFrame: 3 months
measure: change of low density lipoprotein cholesterol
timeFrame: 3 months
measure: change of triglyceride
timeFrame: 3 months
Secondary outcomes:
measure: Compliance rate of blood pressure
timeFrame: 12 months
measure: Compliance rate of glycosylated hemoglobin
timeFrame: 12 months
measure: Compliance rate of low density lipoprotein cholesterol
timeFrame: 12 months
Other outcomes:
measure: Change of the total costs of hypertension treatment
timeFrame: 12 months
measure: Change of the medicine costs of hypertension treatment
timeFrame: 12 months
measure: Change of the total costs of diabetes treatment
timeFrame: 12 months
measure: change of the medicine costs of diabetes treatment
timeFrame: 12 months
measure: Change of the total costs of hyperlipidemia treatment
timeFrame: 12 months
measure: Change of the medicine costs of hyperlipidemia treatment
timeFrame: 12 months
measure: Medication compliance
timeFrame: 12 months
measure: Health self assessment
timeFrame: 12 months
Locations:
city: Beijing
country: China
facility: Beijng Chao Yang Hospital
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Lihong Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: China development research foundation
name: Yue Qiu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: