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

Not yet recruiting

• Conditions: Cardiovascular Risk Factor; Renal Disease; Hypertension
• Interventions: Other: integrated management

• Registration Number: NCT04531124
• Lead Sponsor: Huashan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-15
• Study First Submitted QC: 2020-08-26
• Last Update Submitted: 2020-08-26
• Study First Posted: 2020-08-28
• Last Update Posted: 2020-08-28
• Study Start: 2020-09-01
• Primary Completion: 2025-08-30
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
observational group with an integrated management	integrated management	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

HuashanH; 🇨🇳 Shanghai, Shanghai, China