Clinical trial NCT03708601: Prognostic Risk of Patients With Essential Hypertension for Cardiovascular Events (PROSPECT)
Official title: Prognostic Risk of Patients With Essential Hypertension for Cardiovascular Events
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Essential Hypertension
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
Collaborators: name: Shanxi Medical University
First posted: 2018-10-17
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The case group consists of patients who was diagnosed as Essential Hypertension; control group is general population without Essential Hypertension

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.

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.

Primary outcomes:
measure: Number of cardiovascular adverse events
timeFrame: These data is collected from the cases' medical record or during follow-up visit at 1-3 years after discharge.
measure: Number of cerebrovascular adverse events
timeFrame: These data is collected from the cases' medical record or during follow-up visit at 1-3 years after discharge.
measure: Number of renal adverse events
timeFrame: These data is collected from the cases' medical record or during follow-up visit at 1-3 years after discharge.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases
name: Jie Du, PhD
role: STUDY_DIRECTOR
References:
citation: Yin W, Li F, Tan X, Wang H, Jiang W, Wang X, Li S, Zhang Y, Han Q, Wang Y, Du J. Plasma Ceramides and Cardiovascular Events in Hypertensive Patients at High Cardiovascular Risk. Am J Hypertens. 2021 Nov 20;34(11):1209-1216. doi: 10.1093/ajh/hpab105.