NCT04660630

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

December 9, 2020

Status Verified

December 1, 2020

Enrollment Period

3.9 years

First QC Date

November 19, 2020

Last Update Submit

December 8, 2020

Conditions

Hypertension,EssentialDiabetes type2Hyperlipidemias

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (3)

  • Compliance rate of blood pressure

    12 months

  • Compliance rate of glycosylated hemoglobin

    12 months

  • Compliance rate of low density lipoprotein cholesterol

    12 months

Other Outcomes (8)

  • Change of the total costs of hypertension treatment

    12 months

  • Change of the medicine costs of hypertension treatment

    12 months

  • Change of the total costs of diabetes treatment

    12 months

  • +5 more other outcomes

Study Arms (3)

Precision group

EXPERIMENTAL

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 diseasesBehavioral: Regular follow-up and patient education

Experience group

ACTIVE COMPARATOR

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

Observation group

NO INTERVENTION

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

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.

Also known as: Drug gene chip
Precision group
Regular follow-up and patient educationBEHAVIORAL

The subjects received regular follow-up and patient education.

Experience groupPrecision group

Eligibility Criteria

Age55 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.
  • Patients who can provide real and reliable information related to drug treatment and efficacy evaluation

You may not qualify if:

  • Respondents who are not willing to fill in the true and reliable information form for any reason.
  • Patients with infectious diseases or serious life-threatening diseases such as malignant tumors.
  • Patients with severe liver and kidney function damage, affecting the choice of treatment drugs.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijng Chao Yang Hospital

Beijing, 100020, China

Location

MeSH Terms

Conditions

Essential HypertensionHyperlipidemias

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lihong Liu, Doctor

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

  • Yue Qiu, Doctor

    China development research foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 19, 2020

First Posted

December 9, 2020

Study Start

January 21, 2020

Primary Completion

December 20, 2023

Study Completion

January 20, 2025

Last Updated

December 9, 2020

Record last verified: 2020-12

Locations

CN(1)