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

NCT01740037

Last updated date
Study Location
Martini Ziekenhuis
Groningen, , , Netherlands
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrial Fibrillation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE IntegRAted Chronic Care Program at Specialized AF Clinic Versus Usual CarE in Patients With Atrial Fibrillation - RACE4
Official Title  ICMJE IntegRAted Chronic Care Program at a Specialized Atrial Fibrillation (AF) Clinic Versus Usual CarE in Patients With Atrial Fibrillation, an Investigator-initiated, Prospective, Randomised, Open Label, Blinded Outcome Assessment (PROBE) Controlled Multi-center Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Other: Specialized outpatient AF Clinic
  • Other: Usual Care
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Other: Specialized outpatient AF Clinic
  • Active Comparator: Usual Care
    Usual care provided by cardiologists at the regular outpatient clinic.
    Intervention: Other: Usual Care
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 29, 2017)
1375
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2012)
1716
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740037
Other Study ID Numbers  ICMJE METC 11-2-099
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE
  • Stichting Achmea Gezondheidszor
  • DSW
  • CZ Fonds
  • Bayer
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Pfizer
  • Daiichi Sankyo, Inc.
Investigators  ICMJE
Principal Investigator:H.J.G.M. Crijns, prof. dr.Maastricht University Medical Center
Principal Investigator:I.C. Van Gelder, prof. dr.UMCG
Principal Investigator:R.G. Tieleman, dr.Martini Ziekenhuis
PRS Account Maastricht University Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP