NCT07149688

Brief Summary

This is a prospective observational cohort study conducted in Qujiang District, Zhejiang Province, China, aiming to evaluate the effectiveness of a comprehensive management program for elderly patients with chronic cardiovascular diseases (CVDs). The program integrates pharmacological treatment, lifestyle modification, health education, and long-term follow-up, with enhanced monitoring using 7-day ECG recording. The study focuses on major chronic CVDs including hypertension, coronary artery disease, atrial fibrillation, and heart failure. Approximately 30,000 participants aged ≥60 years will be enrolled and followed for up to 10 years.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
107mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Mar 2024Mar 2035

Study Start

First participant enrolled

March 1, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2035

Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

11 years

First QC Date

August 24, 2025

Last Update Submit

August 24, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Incidence of cardiovascular events

    Incidence of cardiovascular events (myocardial infarction, stroke, hospitalization for heart failure, cardiovascular death) - assessed annually during follow-up

    10 years

  • All-cause and cardiovascular mortality

    All-cause and cardiovascular mortality - assessed at 10 years

    10 years

Secondary Outcomes (2)

  • Hospitalization rates

    10 years

  • Atrial fibrillation burden

    10 years

Interventions

Comprehensive management program (pharmacologic treatment, lifestyle modification, health education, structured follow-up) Enhanced monitoring with 7-day ECG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community-dwelling elderly residents of Qujiang District with chronic cardiovascular diseases.

You may qualify if:

  • Age ≥60 years
  • Resident of Qujiang District
  • Diagnosed with chronic CVD (hypertension, coronary artery disease, heart failure, atrial fibrillation, or others)
  • Able and willing to provide informed consent

You may not qualify if:

  • Severe cognitive impairment or inability to provide consent
  • Life expectancy \<1 year due to non-cardiovascular disease
  • Participation refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationHypertensionCoronary DiseaseHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial Ischemia

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2025

First Posted

September 2, 2025

Study Start

March 1, 2024

Primary Completion (Estimated)

March 1, 2035

Study Completion (Estimated)

March 1, 2035

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations