NCT07611084

Brief Summary

Atrial fibrillation (AF) is a common arrhythmia in aging populations and is strongly associated with an increased risk of heart failure (HF) and adverse cardiovascular outcomes. However, early detection of HF among patients with AF remain inadequate in rural settings. This study aims to screen for HF among older adults with AF in rural China and to conduct long-term follow-up in order to observe the disease progression in patients with AF. This study will recruit at least 2,500 elderly individuals aged between 65 and 80 years, with confirmed diagnoses of AF, residing in rural areas. Participants will undergo HF screening using NT-proBNP testing and echocardiographic assessment. Additionally, data will be collected on electrocardiographic signals, seismocardiography, voice, and demographic characteristics. Following data collection, participants will be followed up every three months to monitor the incidence and progression of HF as well as the occurrence of adverse cardiovascular events.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Mar 2026

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Mar 2026Dec 2029

Study Start

First participant enrolled

March 14, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

3.8 years

First QC Date

May 18, 2026

Last Update Submit

May 22, 2026

Conditions

Atrial Fibrillation (AF)Heart FailureScreeningProgression

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint

    a composite of cardiovascular mortality, all strokes (ischemic or hemorrhagic stroke), hospitalization due to worsening of HF or acute coronary syndrome (ACS), and emergency visits due to AF

    through study completion, an average of 3 years

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population is rural-dwelling older adults aged 65 to 80 years with confirmed atrial fibrillation in China. Participants are required to undergo heart failure screening and provide informed consent. Individuals with severe comorbidities or conditions that may interfere with study participation will be excluded.

You may qualify if:

  • Permanent residents with local household registration in rural China.
  • Aged 65-80 years.
  • Electrocardiogram confirmation of AF or possession of a diagnostic certificate for AF issued by a specialist.
  • Willing to participate in HF screening.
  • Ability to understand the study procedures and provide written informed consent.

You may not qualify if:

  • Expected life expectancy of less than 3 months.
  • Severe renal insufficiency (Ccr \< 30ml/min) or ongoing dialysis treatment.
  • Cardiac insufficiency secondary to correctable causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.
  • Indications for pacemaker implantation without having undergone implantation.
  • Chronic obstructive pulmonary disease complicated by type II respiratory failure.
  • Special populations, including patients with mental illnesses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology

Taizhou, Jiangsu, 225300, China

RECRUITING

Related Publications (1)

  • Chu M, Zhang S, Gong J, Yang S, Yang G, Sun X, Wu D, Xia Y, Jiao J, Peng X, Peng Z, Hong L, Wang Z, Li M, Lip GYH, Chen M; MIRACLE-AF Investigators. Telemedicine-based integrated management of atrial fibrillation in village clinics: a cluster randomized trial. Nat Med. 2025 Apr;31(4):1276-1285. doi: 10.1038/s41591-025-03511-2. Epub 2025 Feb 21.

    PMID: 39984634BACKGROUND

Related Links

MeSH Terms

Conditions

Atrial FibrillationHeart FailureDisease Progression

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Central Study Contacts

Chuanmeng Zhang, Dr.

CONTACT

+8615996000626tzyyzcm@njmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 28, 2026

Study Start

March 14, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD), including baseline characteristics, laboratory results, echocardiographic data, and follow-up outcomes, will be made available upon reasonable request. Data sharing will be subject to approval by the study investigators and in accordance with institutional policies and ethical regulations.

Shared Documents
STUDY PROTOCOL, SAP

Locations

CN(1)