Tongzhou Cohort Study

Active, not recruiting

• Conditions: Hypertension; Obesity
• Interventions: Other: No intervention

• Registration Number: NCT05156580
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

The present study aimed to investigate the impact of obesity on long-term cardiovascular risk in elderly patients with hypertension.

Detailed Description

Overweight status and obesity are important risk factors leading to hypertension, poor blood pressure control, and poor prognosis. However, the studies focused on elderly patients with hypertension are limited. Therefore, the aim of the present study was to evaluate the long-term impact of obesity on cardiovascular risk in elderly patients with hypertension.

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-12-12
• Study First Posted: 2021-12-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-06
• Last Update Posted: 2023-08-08
• Primary Completion: 2026-07-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10750

Inclusion Criteria

• Ages of ≥ 60 years
• History of hypertension and treatment with anti-hypertension drugs for more than 4 weeks
• Availability for follow-up until 2026
• No major barriers to provide written consent

Exclusion Criteria

• NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese hypertensive group	No intervention	Patients who were diagnosed with obesity (body mass index (BMI)≥28kg/m2) and hypertension (systolic blood pressure (SBP)/diastolic blood pressure (DBP) ≥ 140/90 mmHg).
Lean hypertensive group	No intervention	Lean patients (BMI ≤ 24 kg/m2) diagnosed with hypertension (SBP/DBP ≥ 140/90 mmHg).
Overweight hypertensive group	No intervention	Overweight patients (24 kg/m2≤BMI≤28 kg/m2) diagnosed with hypertension (SBP/DBP≥140/90 mmHg).

Primary Outcome Measures

Name	Time	Method
Percentage of participants with major adverse cardiovascular events (MACEs)	2021-2026	Percentage of participants with major adverse cardiovascular events (MACEs), including all-cause death, nonfatal myocardial infarction (MI), nonfatal stroke and coronary revascularization.

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with stroke	2021-2026	Percentage of participants with fatal and nonfatal stroke.
Change in BP control rate	2021-2026	Change in BP control rate (office BP: SBP \< 140 mmHg and DBP \< 90 mmHg) from baseline to follow-up.
Percentage of participants undergoing coronary revascularization	2021-2026	Percentage of participants undergoing ischemia- and non-ischemia-driven coronary revascularization.
Change in estimated glomerular filtration rate (eGFR)	2021-2026	Change in estimated glomerular filtration rate (eGFR) in ml/min/1.73m2 from baseline to follow-up.
Percentage of participants with MI	2021-2026	Percentage of participants with fatal and nonfatal MI.
Percentage of participants with all-cause death	2021-2026	Percentage of participants with cardiovascular, non-cardiovascular and undetermined death.
Change in SBP	2021-2026	Change in SBP from baseline to follow-up.
Change in low-density lipoprotein-cholesterol (LDL-c)	2021-2026	Change in low-density lipoprotein-cholesterol (LDL-c) in mmol/L from baseline to follow-up.

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China