Prognostic Risk of Patients With Essential Hypertension for Cardiovascular Events (PROSPECT)

Essential Hypertension Clinical Trial

Official title:

Prognostic Risk of Patients With Essential Hypertension for Cardiovascular Events

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03708601
• Other study ID #: PROSPECT
• Status: Recruiting
• Start date: September 8, 2016
• Est. completion date: August 8, 2022

Study information

• Verified date: June 2018
• Source: Beijing Institute of Heart, Lung and Blood Vessel Diseases
• Contact: Yuan Wang, PhD
• Phone: 86-010-64456721
• Email: wangyuan980510[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: August 8, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Institute of Heart, Lung and Blood Vessel Diseases	Shanxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cardiovascular adverse events	Number of cardiovascular adverse events including unstable angina, coronary revascularization, acute myocardial infarction, heart failure, atrial fibrillation. revascularization, myocardial infarction, heart failure	These data is collected from the cases' medical record or during follow-up visit at 1-3 years after discharge.
Primary	Number of cerebrovascular adverse events	Number of cerebrovascular adverse events including ischemic stroke and hemorrhagic stroke.	These data is collected from the cases' medical record or during follow-up visit at 1-3 years after discharge.
Primary	Number of renal adverse events	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).	These data is collected from the cases' medical record or during follow-up visit at 1-3 years after discharge.