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

Prognostic Risk of Patients With Essential Hypertension for Cardiovascular Events

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

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Yuan Wang, PhD; Phone Number: 86-010-64456721; Email: wangyuan980510@163.com
• Study Contact Backup: Name: Xin Tan, PhD; Phone Number: 86-010-64456721; Email: tanxin025@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
• Collaborators: Shanxi Medical University
• Investigators: Study Director: Jie Du, phD, 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2016
• Primary Completion (Anticipated): August 8, 2022
• Study Completion (Anticipated): August 8, 2022

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 13, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 24, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: PROSPECT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No