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IntegRAted CarE for Atrial Fibrillation - RACE-4

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Maastricht University Medical Center
Sponsor:
Collaborators:
Stichting Achmea Gezondheidszorg
DSW
CZ fonds
Bayer
Boehringer Ingelheim
Bristol-Myers Squibb
Pfizer
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01740037
First received: October 16, 2012
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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. The secondary objectives include cost-effectiveness, guideline adherence, quality of life, patient knowledge and patient compliance in medication.

Study design: randomized controlled trial with two study arms: usual care provided by cardiologists (control) versus ICCP at a specialized AF-clinic (intervention) in 9 hospitals in the Netherlands. In total 1716 patients with newly diagnosed AF will be included. Total duration of the study is 4,5 years and total mean follow-up will be 2,4 years. Data collected at inclusion, after 3, 6, 12 months and every year thereafter.

Study population: Patients older than 18 year with newly diagnosed AF.

Intervention: treatment through an ICCP at specialized AF clinics, consisting of a nurse specialist, cardiologist-supervisor and a guidelines-based information-communication technology (ICT) decision support program and a web-based patient centered medication management tool and tailored telemonitoring.


Condition Intervention
Atrial Fibrillation
Other: Specialized AF Clinic
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IntegRAted Chronic Care Program at a Specialized Atrial Fibrillation (AF) Clinic Versus Usual CarE in Patients With Atrial Fibrillation, a Multicenter Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Primary endpoint is a composite of unplanned admission to the hospital for any cardiovascular reason and cardiovascular death. [ Time Frame: Participants will be followed at yearly intervals, an expected average of 2.4 years ] [ Designated as safety issue: No ]

    The endpoint events associated with hospitalisation or death are

    1. Left or right ventricular heart failure which is independent of left ventricular ejection fraction (LVEF) and requiring intravenous diuretics;
    2. Ischemic thromboembolic complications including stroke, peripheral, pulmonary or systemic emboli (confirmed by a neurologist on the basis of computerised tomography or MRI);
    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);
    4. Bleeding (a bleeding with the hemoglobin value decreased by > 20 g/ L (>2g/ dL) or requiring blood transfusion
    5. Arrhythmic or potential arrhythmic events (atrial fibrillation, -flutter, other supraventricular rhythm or sustained ventricular tachycardia confirmed by ECG, syncope or cardiac arrest)
    6. Life-threatening adverse effects of rate or rhythm controlling drugs


Secondary Outcome Measures:
  • Costs and cost benefit of the intervention by means of a cost effectiveness analysis [ Time Frame: Participants will be followed an expected average of 2.4 years ] [ Designated as safety issue: No ]
  • The extent to which the comprehensive cardiovascular treatment is in accordance to the 2010 European Society of Cardiology (ESC) AF guidelines, the 2008 ESC Heart Failure guidelines and the 2007 ESC Cardiovascular Disease Prevention guidelines [ Time Frame: Participants will be followed an expected average of 2.4 years ] [ Designated as safety issue: No ]
  • Patient quality of life [ Time Frame: Participants will be followed an expected average of 2.4 years ] [ Designated as safety issue: No ]
  • Patient anxiety and/ or depression [ Time Frame: Participants will be followed an expected average of 2.4 years ] [ Designated as safety issue: No ]
  • Patients' knowledge of AF [ Time Frame: Participants will be followed an expected average of 2.4 years ] [ Designated as safety issue: No ]
  • Patients' compliance in medication [ Time Frame: Participants will be followed an expected average of 2.4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1716
Study Start Date: December 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Specialized AF-clinic
Management of AF patients in specialized AF Clinics according to the principles of an integrated chronic care program (ICCP) performed by nurse specialists, supported by an ICT decision support tool based on professional guidelines (CardioConsult AF®) and supervised by a cardiologist. In addition, a web-based patient centered medication management tool (Medication Manager(TM)and tailored telemonitoring at an outpatient AF clinic. 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.
Other: Specialized AF Clinic
Active Comparator: Usual Care
Usual care provided by cardiologists at the regular outpatient clinic.
Other: Usual Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with newly diagnosed AF detected on electrocardiogram (ECG), holder recordings or event recorder with a duration > 30 seconds, in the 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. Current or 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01740037

Contacts
Contact: H.J.G.M. Crijns, prof. dr. +31433875093 hjgm.crijns@mumc.nl
Contact: E.P.J. Wijtvliet, MSc 0031(0)611363733 petra.wijtvliet@mumc.nl

Locations
Netherlands
Martini Ziekenhuis Recruiting
Groningen, Netherlands
Contact: R.G. Tieleman, MD, PhD    +31505446245      
Principal Investigator: R.G. Tieleman, dr.         
UMCG Recruiting
Groningen, Netherlands
Contact: I. C. Van Gelder, MD, PhD    +31503611327      
Principal Investigator: I. C. Van Gelder, prof. dr.         
Kennemer Gasthuis Recruiting
Haarlem, Netherlands
Contact: B Van Vlies, dr.    +31235453545      
Principal Investigator: B. Van Vlies, dr.         
Medisch Centrum Leeuwarden Recruiting
Leeuwarden, Netherlands
Contact: J.R. Folkeringa, drs.    +31582861214      
Principal Investigator: J.R. Folkeringa, drs.         
MUMC+ Recruiting
Maastricht, Netherlands
Contact: H. J. Crijns, MD, PhD    +31433875093      
Principal Investigator: H. J. Crijns, prof. dr.         
Canisius Wilhelmina Ziekenhuis Nijmegen Recruiting
Nijmegen, Netherlands
Contact: L.H.R. Bouwels, drs.    +31243658782      
Principal Investigator: L.H.R. Bouwels, drs.         
Zaans Medisch Centrum Recruiting
Zaandam, Netherlands
Contact: P.N.A. Bronzwaer, dr.    +31756502911      
Principal Investigator: P.N.A. Bronzwaer, dr.         
Isala Recruiting
Zwolle, Netherlands
Contact: A. Elvan, dr.    0031(0)38 - 4244273    a.elvan@isala.nl   
Principal Investigator: A. Elvan, dr.         
Sponsors and Collaborators
Maastricht University Medical Center
Stichting Achmea Gezondheidszorg
DSW
CZ fonds
Bayer
Boehringer Ingelheim
Bristol-Myers Squibb
Pfizer
Investigators
Principal Investigator: H.J.G.M. Crijns, prof. dr. MUMC+
Principal Investigator: I.C. Van Gelder, prof. dr. UMCG
Principal Investigator: R.G. Tieleman, dr. Martini Ziekenhuis
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01740037     History of Changes
Other Study ID Numbers: METC 11-2-099
Study First Received: October 16, 2012
Last Updated: May 1, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Chronic care program
Nurse specialist
Atrial Fibrillation guideline

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014