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出境医 / 临床实验 / Compliance of Blood Pressure and Lipid in Hypertensive Patients Under the Management of Hospitals at Different Levels

Compliance of Blood Pressure and Lipid in Hypertensive Patients Under the Management of Hospitals at Different Levels

Study Description
Brief Summary:
This is a multi-center, prospective cohort study that collects only diagnostic and therapeutic data in subjects but does not interfere with treatment.

Condition or disease
Hypertension

Detailed Description:
The study aims to assess blood pressure and lipid levels, the use of lipid-lowering and antihypertensive drugs, and treatment compliance and adverse events in hypertensive outpatients of 30 hospitals of different levels, following them up for 1 and 3 months after treatment, respectively. The study would reveal the compliance of blood pressure and lipid levels in hypertensive patients under management of hospitals at different levels, and analyze factors affecting blood pressure or lipid levels associated with treatment compliance. Therefore, the study would provide clinical data from the real world for future prevention and control of CVD in China.
Study Design
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Study Type : Observational
Estimated Enrollment : 1800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Compliance of Blood Pressure and Lipid in Hypertensive Patients Under the Management of Hospitals at Different Levels: a Real-world Observational Study
Actual Study Start Date : August 22, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : November 30, 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. The primary endpoint will be compliance of blood pressure in hypertensive patients after 3 months of treatment in hospitals at different levels. [ Time Frame: 3 months ]

    Blood pressure measurement:

    Blood pressure in both upper arms will be measured with a sphygmomanometer, with the patient in the sitting position. The mean value of three tests will be used for statistics. When left and right upper arms show different blood pressures, the higher value will be used for statistics.



Secondary Outcome Measures :
  1. Percentage of outpatients with abnormal blood lipid levels in hospitals at different levels [ Time Frame: 3 months ]
    On a CardioChek dry-type biochemical analyzer, the levels of total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) in fingertip blood samples will be measured after 12-h fasting

  2. Achievement rate of blood lipid levels in hypertensive and dyslipidemic patients after 3 months of treatment in hospitals at different levels [ Time Frame: 3 months ]
    Achievement rate of blood lipid levels in hypertensive and dyslipidemic patients after 3 months of treatment in hospitals at different levels

  3. Compliance of patients towards antihypertensive and lipid-lowering treatments in hospitals at different levels [ Time Frame: 3 months ]
    Compliance of patients towards antihypertensive and lipid-lowering treatments in hospitals at different levels

  4. Factors affecting blood pressure and lipid compliance in different hospitals, such as patient adverse events [ Time Frame: 3 months ]
    Factors affecting blood pressure and lipid compliance in different hospitals, such as patient adverse events

  5. Achievement rate of blood pressure in hypertensive patients under different levels of hospital management after 1 month of treatment [ Time Frame: 1 months ]
    Achievement rate of blood pressure in hypertensive patients under different levels of hospital management after 1 month of treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Initial diagnosis of primary hypertension
Criteria

Inclusion Criteria:

Patients meeting the following criteria will be included:

  1. Age ≥18 years, male or female;
  2. Agreement for blood pressure and lipid testing;
  3. Initial diagnosis of primary hypertension, with blood pressure conforming to the diagnostic criteria of the 2018 Guidelines for the Prevention and Treatment of Hypertension in China [14] (with no antihypertensive drugs, SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg after three tests performed on different days); or a history of primary hypertension but incompliant blood pressure;
  4. Willingness to participate in the study and signing of informed consent.

Exclusion Criteria:

  • Patients meeting the following criteria will be excluded:

    1. Involvement in an interventional clinical research;
    2. Pregnancy or lactation in women;
    3. Complication with malignant tumors;
    4. Diagnosis of non-primary hypertension by researchers;
    5. Impaired cognitive ability;
    6. Researchers believing that the patients have other conditions not suitable for the study.
Contacts and Locations

Contacts
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Contact: wei ma, doctor 13681050902 kmmawei@sina.com
Contact: jie wang, doctor 010-83572221 wang_jie116@126.com

Locations
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China, Hubei
Wuhan Asia Heart Hospital Recruiting
Wuhan, Hubei, China
Contact: Hu Daqing, MD         
Sponsors and Collaborators
China Cardiovascular Association
Investigators
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Principal Investigator: yong huo, master Peking University First Hospital
Tracking Information
First Submitted Date July 3, 2019
First Posted Date July 11, 2019
Last Update Posted Date November 25, 2019
Actual Study Start Date August 22, 2019
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 10, 2019) 		The primary endpoint will be compliance of blood pressure in hypertensive patients after 3 months of treatment in hospitals at different levels. [ Time Frame: 3 months ]
Blood pressure measurement: Blood pressure in both upper arms will be measured with a sphygmomanometer, with the patient in the sitting position. The mean value of three tests will be used for statistics. When left and right upper arms show different blood pressures, the higher value will be used for statistics.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 10, 2019)
  • Percentage of outpatients with abnormal blood lipid levels in hospitals at different levels [ Time Frame: 3 months ]
    On a CardioChek dry-type biochemical analyzer, the levels of total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) in fingertip blood samples will be measured after 12-h fasting
  • Achievement rate of blood lipid levels in hypertensive and dyslipidemic patients after 3 months of treatment in hospitals at different levels [ Time Frame: 3 months ]
    Achievement rate of blood lipid levels in hypertensive and dyslipidemic patients after 3 months of treatment in hospitals at different levels
  • Compliance of patients towards antihypertensive and lipid-lowering treatments in hospitals at different levels [ Time Frame: 3 months ]
    Compliance of patients towards antihypertensive and lipid-lowering treatments in hospitals at different levels
  • Factors affecting blood pressure and lipid compliance in different hospitals, such as patient adverse events [ Time Frame: 3 months ]
    Factors affecting blood pressure and lipid compliance in different hospitals, such as patient adverse events
  • Achievement rate of blood pressure in hypertensive patients under different levels of hospital management after 1 month of treatment [ Time Frame: 1 months ]
    Achievement rate of blood pressure in hypertensive patients under different levels of hospital management after 1 month of treatment
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Compliance of Blood Pressure and Lipid in Hypertensive Patients Under the Management of Hospitals at Different Levels
Official Title Compliance of Blood Pressure and Lipid in Hypertensive Patients Under the Management of Hospitals at Different Levels: a Real-world Observational Study
Brief Summary This is a multi-center, prospective cohort study that collects only diagnostic and therapeutic data in subjects but does not interfere with treatment.
Detailed Description The study aims to assess blood pressure and lipid levels, the use of lipid-lowering and antihypertensive drugs, and treatment compliance and adverse events in hypertensive outpatients of 30 hospitals of different levels, following them up for 1 and 3 months after treatment, respectively. The study would reveal the compliance of blood pressure and lipid levels in hypertensive patients under management of hospitals at different levels, and analyze factors affecting blood pressure or lipid levels associated with treatment compliance. Therefore, the study would provide clinical data from the real world for future prevention and control of CVD in China.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Initial diagnosis of primary hypertension
Condition Hypertension
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 10, 2019) 		1800
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2020
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patients meeting the following criteria will be included:

  1. Age ≥18 years, male or female;
  2. Agreement for blood pressure and lipid testing;
  3. Initial diagnosis of primary hypertension, with blood pressure conforming to the diagnostic criteria of the 2018 Guidelines for the Prevention and Treatment of Hypertension in China [14] (with no antihypertensive drugs, SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg after three tests performed on different days); or a history of primary hypertension but incompliant blood pressure;
  4. Willingness to participate in the study and signing of informed consent.

Exclusion Criteria:

  • Patients meeting the following criteria will be excluded:

    1. Involvement in an interventional clinical research;
    2. Pregnancy or lactation in women;
    3. Complication with malignant tumors;
    4. Diagnosis of non-primary hypertension by researchers;
    5. Impaired cognitive ability;
    6. Researchers believing that the patients have other conditions not suitable for the study.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04015843
Other Study ID Numbers GUSU18006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party China Cardiovascular Association
Study Sponsor China Cardiovascular Association
Collaborators Not Provided
Investigators
Principal Investigator: yong huo, master Peking University First Hospital
PRS Account China Cardiovascular Association
Verification Date June 2019

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