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

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ClinicalTrials.gov Identifier: NCT04015843
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
China Cardiovascular Association

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.

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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
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine





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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015843


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

Sponsors and Collaborators
China Cardiovascular Association
Investigators
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Principal Investigator: yong huo, master Peking University First Hospital

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Responsible Party: China Cardiovascular Association
ClinicalTrials.gov Identifier: NCT04015843     History of Changes
Other Study ID Numbers: GUSU18006
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No