Clinical trial NCT04015843: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Lead sponsor: China Cardiovascular Association
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Initial diagnosis of primary hypertension

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.

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.

Primary outcomes:
measure: The primary endpoint will be compliance of blood pressure in hypertensive patients after 3 months of treatment in hospitals at different levels.
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of outpatients with abnormal blood lipid levels in hospitals at different levels
timeFrame: 3 months
measure: Achievement rate of blood lipid levels in hypertensive and dyslipidemic patients after 3 months of treatment in hospitals at different levels
timeFrame: 3 months
measure: Compliance of patients towards antihypertensive and lipid-lowering treatments in hospitals at different levels
timeFrame: 3 months
measure: Factors affecting blood pressure and lipid compliance in different hospitals, such as patient adverse events
timeFrame: 3 months
measure: Achievement rate of blood pressure in hypertensive patients under different levels of hospital management after 1 month of treatment
timeFrame: 1 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
Study officials:
affiliation: Peking University First Hospital
name: yong huo, master
role: PRINCIPAL_INVESTIGATOR
References: