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Clinical Trials/NCT03708601
NCT03708601
Unknown
Not Applicable

Prognostic Risk of Patients With Essential Hypertension for Cardiovascular Events

Beijing Institute of Heart, Lung and Blood Vessel Diseases1 site in 1 country3,000 target enrollmentSeptember 8, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Essential Hypertension
Sponsor
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Enrollment
3000
Locations
1
Primary Endpoint
Number of cardiovascular adverse events
Last Updated
6 years ago

Overview

Brief Summary

The registry study aims to determine serial biomarkers to prognosis of Essential Hypertension

Detailed Description

The study aims to investigate the role of candidate biomarkers in the prognosis of Essential Hypertension. In the prognosis part of the study, patients with confirmed hypertension are enrolled. The outcome is unstable angina, coronary revascularization, acute myocardial infarction, heart failure, atrial fibrillation, ischemic cerebral infarction, hemorrhagic cerebral infarction, transient ischemic attack, doubling of serum creatinine or end-stage renal disease (defi ned as eGFR less than 15 mL/min/1·73 m² or need for chronic dialysis) and all-cause mortality.

Registry
clinicaltrials.gov
Start Date
September 8, 2016
End Date
August 8, 2022
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The inclusion criteria for the study program were as follows:
  • Men or women of any racial background, 18 years of age and older, with systolic BP greater than or equal to160 mm Hg, and presence of three or more cardiovascular risk factors or disease.
  • The qualifying risk factors were male sex, age older than 50 years, verified diabetes mellitus, current smoking, high total cholesterol, left ventricular hypertrophy by electrocardiogram, proteinuria on dipstick and raised serum creatinine between 150 and 265 umol/L. The qualifying diseases were verified coronary disease, cerebrovascular disease or peripheral arterial occlusive disease, or left ventricular hypertrophy with strain pattern.

Exclusion Criteria

  • The exclusion Criteria for the study program were as follows:
  • Secondary hypertension, pregnancy, history of heart failure or left ventricular ejection fraction less than 40%, myocardial infarction within one month, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting, cerebrovascular disease, severe liver disease, severe chronic renal failure (eGFR less than 30 mL/min/1.73 m2) in the past three months.

Outcomes

Primary Outcomes

Number of cardiovascular adverse events

Time Frame: These data is collected from the cases' medical record or during follow-up visit at 1-3 years after discharge.

Number of cardiovascular adverse events including unstable angina, coronary revascularization, acute myocardial infarction, heart failure, atrial fibrillation. revascularization, myocardial infarction, heart failure

Number of cerebrovascular adverse events

Time Frame: These data is collected from the cases' medical record or during follow-up visit at 1-3 years after discharge.

Number of cerebrovascular adverse events including ischemic stroke and hemorrhagic stroke.

Number of renal adverse events

Time Frame: These data is collected from the cases' medical record or during follow-up visit at 1-3 years after discharge.

Number of renal adverse events including Double serum creatinine or end-stage renal disease (eGFR less than 15 mL/min/1.73 m2 or dialysis required).

Study Sites (1)

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