Cardiovascular and Renal Outcomes of Integrated Management of Blood Pressure and Other Cardiometabolic Risks in Hypertensives

Cardiovascular and Renal Outcomes of Integrated Management of Blood Pressure and Other Cardiometabolic Risks in Hypertensives：a Multicenter Prospective Cohort Study （UPDATE-cohort）

this clinical trial is designed to study the cardiovascular and renal outcomes of hypertensives after an integrated management of blood pressure and other cardiometabolic risks. it is a multicenter prospective cohort study.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Cardiovascular Risk Factor; Renal Disease
• Intervention / Treatment: Other: integrated management

• Study Type: Observational
• Enrollment (Anticipated): 30000

Contacts and Locations

• Study Contact: Name: yong li, professor; Phone Number: china shanghai +86 13801753494; Email: liyong606@126.com
• Study Contact Backup: Name: xiufang gao, associate professor; Phone Number: +86 13788908071; Email: sophiakao@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200036
      • HuashanH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

outpatients with hypertension in different levels of hospitals in Shanghai, China

Description

Inclusion Criteria:

1. Outpatients from departments of Cardiology, Endocrinology, Nephrology, Neurology, Geriatrics or General Internal Medicine.
2. Diagnosed as hypertension. Diagnostic criteria: 1)The office BP measured at the day of visit and at least one time before that day were above the cut-off values ( ≥140 mmHg SBP and/or ≥90 mmHg DBP); 2)for patients with normal BP at the day of visit, they should have already been given pre-treatment with antihypertensive drugs ≥ 2 weeks.
3. Voluntary participation.

Exclusion Criteria:

1. Patients aged< 18 years old.
2. Patients without a definite diagnosis of hypertension(for instance, if the patient has been taking antihypertensive drugs irregularly, it is difficult to confirm the diagnosis of hypertension).
3. Patients with a definite diagnosis of secondary hypertension.
4. Patients are diagnosed dyslipidemia with clear cause, such as nephrotic syndrome, severe hypothyroidism, terminal stage of malignancy, etc.
5. Patients are diagnosed end-stage renal disease, hemodialysis, and peritoneal dialysis patients.
6. Patients diagnosed with mental abnormalities who are unable to complete the questionnaire.
7. Patients have once participated in this research during this study cycle(to avoid repeated participation).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control group without an integrated management
observational group with an integrated management	Other: integrated management; establish an integrated management on cardio-metabolic risk factors including hypertension by updating and upgrading the daily practice of practitioners and screening patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complex outcome	number of participants with 3P-MACE events(cardiovascular deaths, non-fatal myocardial infarction, non-fatal stroke)	follow-up 1 year
coronary angioplasty	number of participants with coronary angioplasty	follow-up 1 year
acute renal failure	number of participants with acute renal failure(eGFR decreases by 50% or <15ml/min/1.73m2, dialysis or renal death)	follow-up 1 year
acute heart failure	number of participants with acute heart failure(non-scheduled hospitalizations due to heart failure or required intravenous medication)	follow-up 1 year

Collaborators and Investigators

• Sponsor: Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): August 30, 2025
• Study Completion (Anticipated): February 28, 2026

Study Registration Dates

• First Submitted: August 15, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Hypertension; Kidney Diseases
• Other Study ID Numbers: Huashan cardiology

Drug and device information, study documents

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