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

NCT ID: NCT01740037

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2018-09-30

Brief Summary

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Specialized AF-clinic

Management of AF patients in specialized outpatient AF Clinics according to the principles of an integrated chronic care program (ICCP) performed by a nurse practitioner/ physician assistant/ specialised cardiovascular nurse, cardiologist, supported by an ICT decision support tool based on professional guidelines (CardioConsult AF®). 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. In addition, the intervention is based on identifying risk factors and potential problems in patients, and addressing needs through dynamic use of personalized education and adjustment of treatment.

Group Type: EXPERIMENTAL

Specialized outpatient AF Clinic

Intervention Type: OTHER

Usual Care

Usual care provided by cardiologists at the regular outpatient clinic.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Interventions

Specialized outpatient AF Clinic

Intervention Type: OTHER

Usual Care

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stichting Achmea Gezondheidszor

OTHER

Sponsor Role: collaborator

DSW

UNKNOWN

Sponsor Role: collaborator

CZ Fonds

OTHER

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

H.J.G.M. Crijns, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

I.C. Van Gelder, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

UMCG

R.G. Tieleman, dr.

Role: PRINCIPAL_INVESTIGATOR

Martini Ziekenhuis

Locations

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

Countries

Netherlands

References

Wijtvliet EPJP, Tieleman RG, van Gelder IC, Pluymaekers NAHA, Rienstra M, Folkeringa RJ, Bronzwaer P, Elvan A, Elders J, Tukkie R, Luermans JGLM, Van Asselt ADIT, Van Kuijk SMJ, Tijssen JG, Crijns HJGM; RACE 4 Investigators. Nurse-led vs. usual-care for atrial fibrillation. Eur Heart J. 2020 Feb 1;41(5):634-641. doi: 10.1093/eurheartj/ehz666.

Reference Type: DERIVED

PMID: 31544925 (View on PubMed)

Other Identifiers

METC 11-2-099

Identifier Type: -

Identifier Source: org_study_id