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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04531124
Other study ID # Huashan cardiology
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date February 28, 2026

Study information

Verified date August 2020
Source Huashan Hospital
Contact yong li, professor
Phone +86 13801753494
Email liyong606@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30000
Est. completion date February 28, 2026
Est. primary completion date August 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Intervention

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

Locations

Country Name City State
China HuashanH Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary complex outcome number of participants with 3P-MACE events(cardiovascular deaths, non-fatal myocardial infarction, non-fatal stroke) follow-up 1 year
Primary coronary angioplasty number of participants with coronary angioplasty follow-up 1 year
Primary 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
Primary 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
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