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Resynchronization/Defibrillation for Ambulatory Heart Failure Trial in Patients With Permanent Atrial Fibrillation (RAFT-PermAF)

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ClinicalTrials.gov Identifier: NCT01994252
Recruitment Status : Recruiting
First Posted : November 25, 2013
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Brief Summary:

Atrial fibrillation (AF) and heart failure (HF) are two common heart conditions that are encountered with an increase in death and suffering. When both these two conditions occur in a patient, the patient's prognosis is poor with a reduced quality of life and impaired heart function. These patients have enlarged hearts, specifically the left ventricle (major pumping chamber), which impairs the heart's pumping capacity, leading to symptoms such as fatigue, shortness of breath from any type of exertion, and swelling, usually of the feet and ankles.

In these HF patients who are in AF all of the time, who would otherwise be a suitable candidate for an implantable defibrillator to prevent sudden cardiac death, we would like to determine whether adding pacing of both ventricles will reduce heart size (left ventricular end systolic volume index LVESVi) as measured by ultrasound, which can improve its function and help the heart pump more efficiently.

Other studies have shown that adding pacing to both ventricles is of benefit in HF patients with mild to moderate symptoms and have a regular heart rhythm. The Investigators now want to explore if this therapy will benefit those patients with a permanent irregular heart rhythm (AF).


Condition or disease Intervention/treatment Phase
Heart Disease Congestive Heart Failure Atrial Fibrillation Device: Optimal Medical therapy plus ICD Device: Optimal Medical therapy plus CRT/ICD Not Applicable

Detailed Description:

NEW:

Heart failure (HF) is increasing in prevalence and incidence, and is the most common reason for hospital admissions of patients over the age of 65. Therapy for HF has evolved over the last two decades. Cardiac resynchronization therapy (CRT) is a therapy that attempts to resynchronize the sequence of ventricular contraction in heart failure (HF) patients with left ventricular (LV) systolic dysfunction and ventricular dyssynchrony. CRT is achieved by stimulating both RV and LV together, synchronized to right atrial excitation to achieve atrio-ventricular synchrony. Clinical trials have demonstrated that CRT reduced heart size (left ventricular end systolic volume index LVESVi), improved survival and reduced HF hospitalization in mild to advanced HF patients. In addition, CRT reversed the remodeling process such that it was associated with a reduction of LV size, and an increase of LV ejection fraction (EF). This knowledge translated to a change in practice guidelines and the adoption of CRT into clinical practice benefitting many HF patients CRT is now an important state-of-the-art therapy for HF patients with LV systolic dysfunction, low LVEF, and prolonged QRS duration in sinus rhythm, since the vast majority of the CRT clinical research was performed in patients in sinus rhythm. However, in the ~25% of HF patients with permanent atrial fibrillation (AF), the effectiveness of CRT is not clear. It is therefore timely to address the question of whether the addition of CRT to optimal HF treatment, rate control and an ICD is beneficial in reducing LVESVi in HF patients in permanent AF with LV systolic dysfunction and prolonged QRS duration

Objectives: To determine whether cardiac resynchronization therapy will reduce Left Ventricular End-Systolic Volume index (LVESVi) for heart failure patients with permanent atrial fibrillation, mild to moderate heart failure, left ventricular systolic dysfunction, and prolonged QRS duration, when compared to implantable cardioverter defibrillator (ICD) therapy alone.

Methods: This is a multi-centre randomized controlled trial of two treatment groups. The patients, primary physicians and the heart failure caregivers will be blinded to the treatment allocation. The device follow-up caregivers will not be blinded. Patients with NYHA Class II and III HF symptoms, LVEF HF ≤ 35% , permanent AF, on optimal medical therapy and QRS durations ≥ 130 ms when the QRS morphology is LBBB, or QRS durations ≥ 150 ms when the QRS morphology is non-LBBB, or Paced QRS will be included in the trial. Patients should be suitable candidates for either of the 2 treatment strategies. There will be 200 patients randomized in 1:1 ratio to two groups: 1) ICD-CRT, 2) ICD only. All patients will undergo baseline clinical evaluation, echocardiogram measurements, quality of life assessment, medication assessment, and NT-proBNP. The patients will be followed at 1 month, 3 months, 6 months and then every 6 months. Follow up echocardiograms will be done at 6 and 12 month follow ups to evaluate LVESVi. Quality of life assessment, and 6-minute walk distance will also be performed at baseline and at follow-up visits.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Resynchronization/Defibrillation for Ambulatory Heart Failure Trial in Patients With Permanent Atrial Fibrillation
Study Start Date : August 2013
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Optimal Medical therapy plus ICD
Patients randomized to the (ICD) Implantable-Defibrillator-Cardioverter only group will receive an ICD + optimal medical therapy
Device: Optimal Medical therapy plus ICD
Active Comparator: Optimal Medical therapy plus CRT/ICD
Patients randomized to the (ICD) Implantable-Defibrillator-Cardioverter plus cardiac resynchronisation therapy (CRT) group will receive an ICD + CRT and optimal medical therapy
Device: Optimal Medical therapy plus CRT/ICD



Primary Outcome Measures :
  1. The primary outcome is a reduction of Left Ventricular End Systolic Volume index (LVESVi) [ Time Frame: 7 year study ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 7 year study ]
  2. Hospitalization for Heart Failure [ Time Frame: 7 year study ]
  3. Cardiovascular mortality [ Time Frame: 7 year study ]
  4. Cost-effectiveness [ Time Frame: 41/2 year study ]
  5. Quality of Life Measures [ Time Frame: 7 year study ]
  6. 6 Minute walk distance [ Time Frame: 7 year study ]
  7. Cardiovascular hospitalizations [ Time Frame: 7 year study ]
  8. Composite of all-cause mortality and heart failure [ Time Frame: 7 year study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with NYHA Class II or III HF symptoms (assessment in the last 3 months)
  • Permanent AF
  • Optimal Medical Therapy for HF of at least 3 months (according to 2009 ACCF/AHA and ESC 2012 recommendations,)
  • LVEF ≤ 35% (assessment in the last 6 months)
  • Candidacy for an ICD for primary or secondary prevention of sudden cardiac death
  • QRS durations ≥ 130 ms when the QRS morphology is LBBB, or QRS durations ≥ 150 ms when the QRS morphology is non-LBBB or Paced QRS

Exclusion Criteria:

  • In-hospital patients who have acute cardiac or non-cardiac illness that requires intensive care
  • Intra-venous inotropic agent in the last 4 days
  • Patients with a life expectancy of less than one year from non-cardiac cause.
  • Expected to undergo cardiac transplantation within one year (status I)
  • Acute coronary syndrome (including MI) < 4 weeks
  • Unable or unwilling to provide informed consent
  • Uncorrected or uncorrectable primary valvular disease
  • Restrictive, hypertrophic or reversible form of cardiomyopathy
  • Severe primary pulmonary disease such as cor pulmonale
  • Tricuspid prosthetic valve
  • Patients included in other clinical trial that will affect the objectives of this study
  • Coronary revascularization (CABG or PCI) < 3 months
  • Patients with an existing ICD or CRT pacemaker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994252


Contacts
Contact: Anthony SL Tang, MD 519-663-3746 anthonysltang@gmail.com
Contact: George A Wells, PhD

Locations
Canada, Alberta
Libin Cardiovascular Institute of Alberta Recruiting
Calgary, Alberta, Canada
Principal Investigator: Derrek Exner, MD         
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Principal Investigator: Matthew Bennett, MD         
Victoria Cardiac Arrhythmia Trials Recruiting
Victoria, British Columbia, Canada, V8R 4R2
Contact: Paul Novak, MD    250-595-0400      
Principal Investigator: Paul Novak, MD         
Canada, Manitoba
St. Boniface General Hospital Recruiting
Winnipeg, Manitoba, Canada
Principal Investigator: Colette Seifer, MD         
Canada, Nova Scotia
Queen Elizabeth II Health Science Recruiting
Halifax, Nova Scotia, Canada
Principal Investigator: Ratika Parkash, MD         
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada
Principal Investigator: Jeff Healey, MD         
Kingston General Hospital Recruiting
Kingston, Ontario, Canada
Principal Investigator: Damian Redfearn, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Raymond Yee, MD    519-663-3746      
Principal Investigator: Peter Leong-Sit, MD         
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1W 4W7
Contact: David H Birnie, MD    613 696 77269      
Principal Investigator: David H. Birnie, MD         
St. Michael's General Hospital Recruiting
Toronto, Ontario, Canada
Principal Investigator: Paul Angaran, MD         
Canada, Quebec
McGill Health Science Centre Recruiting
Montreal, Quebec, Canada
Principal Investigator: Vidal Essebag, MD         
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada
Principal Investigator: Bernard Thibault, MD         
CHUM Centre hospitalier universitaire de Montréal Recruiting
Montréal, Quebec, Canada
Principal Investigator: Benoit Coutu, MD         
Hôpital du Sacré-Cœur de Montréal Not yet recruiting
Montréal, Quebec, Canada
Principal Investigator: Marcio Sturmer, MD         
Institut universitaire de cardiologie et de pneumologie de Quebec Not yet recruiting
Quebec City, Quebec, Canada
Principal Investigator: François Philippon, MD         
Le Centre hospitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada
Contact: Felix Ayala-Paredes, MD         
Principal Investigator: Felix Ayala-Paredes, MD         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Anthony SL Tang, MD Ottawa Heart Institute Research Corporation

Publications:
Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT01994252     History of Changes
Other Study ID Numbers: RN00208414
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

Keywords provided by Ottawa Heart Institute Research Corporation:
defibrillator
cardiac resynchronization

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