EligibleTrials

Novel Model of Integrated Care of Older Patients With Atrial Fibrillation and Heart Failure in Rural China (MIRACLE-AFHF)

Recruiting · NCT07492524 · Interventional (participants receive a specific treatment) · Lead sponsor: Jiangsu Taizhou People's Hospital

View the official record on ClinicalTrials.gov →
Atrial FibrillationHeart Failure

Interventions studied

Usual CareVillage-Doctor Led Integrated Care

What this trial is about

This cluster randomization study aims to compare village-doctor led integrated care versus usual care to improve heart failure risk management, guideline-directed medical therapy, self-management adherence, and clinical outcomes for older patients with atrial fibrillation and heart failure in rural China.

Who can take part

Age range
65 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)

Eligibility criteria (as published)

1\. The village clinics need to be willing and able to provide integrated care to their patients with atrial fibrillation; 2. The village doctors from one village clinic serves all AF patients from 3-5 nearby villages; 3. The village doctors are trained to have a fundamental understanding of telemedicine; 4. Patients are eligible for participation if 1)they aged 65-80 years. 2) Electrocardiogram (ECG) confirmation of AF or possession of a diagnostic certificate for AF issued by a specialist. 3) A documented history of HF or a diagnosis of HF based on echocardiography and/or NT-proBNP screening, defined by the presence of typical HF symptoms and/or signs, together with one of the following: reduced left ventricular ejection fraction (HFrEF; LVEF \< 40%), mildly reduced left ventricular ejection fraction (HFmrEF; LVEF 40-49%), or preserved left ventricular ejection fraction with elevated NT-proBNP and structural heart disease changes (HFpEF; LVEF ≥ 50%, meeting at least one of the following criteria: LAV 40 ml/m², E/e' ≥ 15, or TRV \> 2.8 m/s). 4) Management by a village clinic near the participant's place of residence. 5) Ability to understand the study procedures and provide written informed consent. Exclusion Criteria: 1. Expected life expectancy of less than 12 months. 2. Severe renal insufficiency (Ccr \< 30ml/min) or ongoing dialysis treatment. 3. Cardiac insufficiency secondary to correctable causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease. 4. Indications for pacemaker implantation without having undergone implantation. 5. Chronic obstructive pulmonary disease (COPD) complicated by type II respiratory failure. 6. Special populations, including patients with mental illnesses.

Where it is running

6 locations listed.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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