IntegRAted Chronic Care Program at Specialized AF Clinic Versus Usual CarE in Patients With Atrial Fibrillation - RACE4

Maastricht University Medical Center1,375 enrolled

Overview

Rationale: The treatment of patients with atrial fibrillation is often inadequate due to poor guideline adherence. An integrated chronic care program (ICCP) at a specialized AF-clinic was found to be superior to usual care provided by a cardiologist in terms of cardiovascular hospitalizations and cardiovascular mortality. Hypothesis: treatment at a specialized AF clinic is superior to usual care in terms of cardiovascular mortality and cardiovascular hospitalizations, cost-effectiveness, quality of life and guideline adherence. Objectives: primary objective is to show that an ICCP reduces cardiovascular hospitalizations and mortality. Study design: randomized controlled trial with two study arms: usual care provided by cardiologists (control) versus integrated chronic care program at a specialized AF clinic (intervention) in 8 hospitals in the Netherlands. The RACE4 is an event driven study. A total number of 246 events is needed. In total 1716 patients with newly diagnosed AF will be included. Total duration of the study is 5 years and 10 months with a minimal follow up of 1 year. Data is collected at inclusion, after 3, 6, 12 months, every year thereafter and at the end of the study. Study population: Patients older than 18 year with newly diagnosed AF. Intervention: The intervention is delivered through the specialized outpatient AF clinic. The multidisciplinary team at the AF clinic consists of a nurse practitioner or physician assistant or specialised cardiovascular nurse, cardiologist, and is guided by guidelines-based decision support software program based on the applicable ESC guideline recommendations. The use of a web-based patient centered management of patient's own medication (Medication manager TM) was optional. A standardized diagnostic, treatment and follow-up pathway was performed within the ICCP.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with newly diagnosed AF detected on electrocardiogram (ECG), holter recordings or event recorder with a duration \> 30 seconds, 3 months before inclusion or 2. Patients with a history of diagnosed AF, with no regular control at a cardiologist for AF in the last 2 years and referred by a (non-)cardiologic medical specialist for new diagnostics or therapeutic issue; 3. Age ≥18 years. Exclusion Criteria: 1. No electrocardiographic objectified AF; 2. Unstable heart failure defined as NYHA IV or heart failure necessitating hospital admission \< 3 months before inclusion; 3. Acute coronary syndrome (acute myocardial infarction or instable angina pectoris, with two of the following characteristics: chest pain and/ or ischemic electrocardiographic changes, and/ or cardiac enzyme rise) \< 3 months before inclusion; 4. Untreated hyperthyroidism or \< 3 months euthyroidism before inclusion; 5. Foreseen pacemaker, internal cardioverter defibrillator, and/ or cardiac resynchronization therapy; 6. Cardiac surgery ≤ 3 months before inclusion; 7. Planned cardiac surgery; 8. Regular control and treatment, also for AF, at another specialized outpatient cardiac clinic; 9. Patient is not able to fill in the questionnaires; 10. Participation in other clinical study.

Locations (8)

Martini Ziekenhuis

Groningen, Netherlands

UMCG

Groningen, Netherlands

Spaarne Gasthuis

Haarlem, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

MUMC+

Maastricht, Netherlands

Canisius Wilhelmina Ziekenhuis Nijmegen

Nijmegen, Netherlands

Zaans Medisch Centrum

Zaandam, Netherlands

Isala

Zwolle, Netherlands

Outcomes

Primary Outcomes

The primary endpoint is a composite of unplanned admission to the hospital for any cardiovascular reason and cardiovascular death.