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IntegRAted CarE for Atrial Fibrillation - RACE-4 (RACE-4)

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ClinicalTrials.gov Identifier: NCT01740037
Recruitment Status : Active, not recruiting
First Posted : December 4, 2012
Last Update Posted : January 24, 2018
Sponsor:
Collaborators:
Stichting Achmea Gezondheidszor
DSW
CZ Fonds
Bayer
Boehringer Ingelheim
Bristol-Myers Squibb
Pfizer
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Maastricht University Medical Center

October 16, 2012
December 4, 2012
January 24, 2018
December 2012
November 2018   (Final data collection date for primary outcome measure)
Primary endpoint is a composite, defined as unplanned admission to the hospital for any cardiovascular reason and cardiovascular death. [ Time Frame: Participants will be followed at yearly intervals, minimum follow up of 1 year and maximum follow up of 6 years ]
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 ]

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
Complete list of historical versions of study NCT01740037 on ClinicalTrials.gov Archive Site
  • Costs and cost benefit of the intervention by means of a cost effectiveness analysis [ Time Frame: Participants will be followed with minimum follow up of 1 year and maximum follow up of 6 years ]
  • The extent to which the comprehensive cardiovascular treatment is in accordance to the latest European Society of Cardiology (ESC) AF guidelines, the ESC Heart Failure guidelines and the ESC Cardiovascular Disease Prevention guidelines [ Time Frame: Participants will be followed with minimum follow up of 1 year and maximum follow up of 6 years ]
  • Patient quality of life [ Time Frame: Participants will be followed with minimum follow up of 1 year and maximum follow up of 6 years ]
  • Patient anxiety and/ or depression [ Time Frame: Participants will be followed with minimum follow up of 1 year and maximum follow up of 6 years ]
  • Patients' knowledge of AF [ Time Frame: Participants will be followed with minimum follow up of 1 year and maximum follow up of 6 years ]
  • Patients' compliance in medication [ Time Frame: Participants will be followed with minimum follow up of 1 year and maximum follow up of 6 years ]
  • Costs and cost benefit of the intervention by means of a cost effectiveness analysis [ Time Frame: Participants will be followed at yearly intervals, an expected average of 2.4 years ]
  • 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 at yearly intervals, an expected average of 2.4 years ]
  • Patient quality of life [ Time Frame: Participants will be followed at yearly intervals, an expected average of 2.4 years ]
  • Patient anxiety and/ or depression [ Time Frame: Participants will be followed at yearly intervals, an expected average of 2.4 years ]
  • Patients' knowledge of AF [ Time Frame: Participants will be followed at yearly intervals, an expected average of 2.4 years ]
  • Patients' compliance in medication [ Time Frame: Participants will be followed at yearly intervals, an expected average of 2.4 years ]
Not Provided
Not Provided
 
IntegRAted CarE for Atrial Fibrillation - RACE-4
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

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 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 6 years with a minimal follow up of 1 year and maximum of 6 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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Atrial Fibrillation
  • Other: Specialized AF Clinic
  • Other: Usual Care
  • 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.
    Intervention: Other: Specialized AF Clinic
  • Active Comparator: Usual Care
    Usual care provided by cardiologists at the regular outpatient clinic.
    Intervention: Other: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1375
1716
November 2018
November 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01740037
METC 11-2-099
Yes
Not Provided
Not Provided
Maastricht University Medical Center
Maastricht University Medical Center
  • Stichting Achmea Gezondheidszor
  • DSW
  • CZ Fonds
  • Bayer
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Pfizer
  • Daiichi Sankyo, Inc.
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
Maastricht University Medical Center
January 2018

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