Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02132767 |
|
Recruitment Status :
Completed
First Posted : May 7, 2014
Results First Posted : January 18, 2017
Last Update Posted : March 15, 2019
|
Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Annetine Gelijns, Icahn School of Medicine at Mount Sinai
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in hospital within 60 days of the occurrence of AF compared to a strategy of rate control.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postoperative Atrial Fibrillation | Drug: Amiodarone Procedure: DC-cardioversion Drug: Rate Control | Phase 3 |
The purpose of the research is to compare two strategies for treating atrial fibrillation or atrial flutter, both of which are referred to as AF, after cardiac surgery. AF is the most common complication after cardiac surgery. AF is when the upper chambers of the heart (atria) experience disorganized electrical activity which causes the heart beat to be irregular. The two treatment strategies to be used in this study are called rhythm control and rate control. The rhythm control strategy will attempt to bring the heart beat back to a regular rhythm using treatments known and approved to control heart rhythm. The rate control strategy will attempt to bring the heart rate to less than 100 beats per minute at rest using medications known and recommended to control heart rate. Both strategies are commonly used to treat AF. All of the medications that will be used in this study are the standard of care for use in patients experiencing AF. This research seeks to determine whether rhythm control is better than rate control in patients with AF after cardiac surgery.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 523 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation |
| Study Start Date : | May 2014 |
| Actual Primary Completion Date : | September 2015 |
| Actual Study Completion Date : | September 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Rhythm control
Rhythm Control in post-operative AF Amiodarone and/or DC-cardioversion Amiodarone Initial Dose
DC-Cardioversion - frequency and duration determined by medical professional as medically needed |
Drug: Amiodarone
Amiodarone Initial Dose
Other Name: Cordarone Procedure: DC-cardioversion DC-Cardioversion - frequency and duration determined by medical professional as medically needed
Other Name: Direct Current Cardioversion |
|
Active Comparator: Rate control
Rate Control in post-operative AF Beta-blocker and/or Calcium channel blockers and/or Digoxin Dose, frequency and duration determined by medical professional as medically needed |
Drug: Rate Control
Beta-blocker and/or Calcium channel blockers and/or Digoxin - Dose, frequency and duration determined by medical professional as medically needed
Other Names:
|
Primary Outcome Measures :
- Total Number of Days in Hospital [ Time Frame: Within 60 days of randomization ]The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.
Secondary Outcome Measures :
- Time to Conversion to Sustained, Stable Non-AF Rhythm [ Time Frame: Up to index hospital discharge or 7 days post surgery, whichever came first ]
- Heart Rhythm Comparison [ Time Frame: Hospital discharge ]Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge
- Heart Rhythm Comparison [ Time Frame: 30 days after randomization ]Compare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization
- Heart Rhythm Comparison [ Time Frame: 60 days after randomization ]Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization
- Length of Stay (Index Hospitalization) [ Time Frame: Within 60 days post surgery ]Overall length of stay for the index hospitalization
- Length of Stay (Rehospitalization, Including ED Visits) [ Time Frame: Within 60 days of randomization ]Compare length of stay between groups for any cause and AF-related hospitalizations, including ED visits
- Outpatient Interventions [ Time Frame: Within 60 days of randomization ]Compare frequency of outpatient visits between groups for any cause and AF-related causes
- AF- or Treatment-related Events [ Time Frame: Within 60 days of randomization ]
- Cost (Hospital) [ Time Frame: Within 60 days of randomization ]Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Enrollment Inclusion Criteria:
- Age > 18 years
- Undergoing heart surgery for coronary artery bypass (on-pump or off-pump CABG) and/or valve repair or replacement (excluding mechanical valves), including re-operations
- Hemodynamically stable
Randomization Inclusion Criteria
- AF that persists for > 60 minutes or recurrent (more than one) episodes of AF up to 7 days after surgery during the index hospitalization.
Exclusion Criteria:
- LVAD insertion or heart transplantation
- Maze procedure
- TAVR
- History of or planned mechanical valve replacement
- Correction of complex congenital cardiac defect (excluding bicuspid aortic valve, atrial septal defect or PFO)
- History of AF or AFL
- History of AF or AFL ablation
- Contraindications to warfarin or amiodarone
- Need for long-term anticoagulation
- Concurrent participation in an interventional (drug or device) trial
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): NCT02132767
Locations
Show 23 study locations
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
Canadian Institutes of Health Research (CIHR)
Investigators
| Study Chair: | Richard Wiesel, MD | Cardiothoracic Surgical Trials Network | |
| Study Chair: | Patrick T O'Gara, MD | Cardiothoracic Surgical Trials Network |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Annetine Gelijns, Professor and Chair, Health Evidence and Policy, Icahn School of Medicine at Mount Sinai |
| ClinicalTrials.gov Identifier: | NCT02132767 |
| Other Study ID Numbers: |
GCO 08-1078-00007 5U01HL088942-08 ( U.S. NIH Grant/Contract ) |
| First Posted: | May 7, 2014 Key Record Dates |
| Results First Posted: | January 18, 2017 |
| Last Update Posted: | March 15, 2019 |
| Last Verified: | February 2019 |
Keywords provided by Annetine Gelijns, Icahn School of Medicine at Mount Sinai:
|
Heart surgery Cardiac surgery Coronary artery bypass Mitral valve surgery Aortic valve surgery |
Atrial fibrillation Atrial flutter Cardiac arrhythmia Valve surgery |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Digoxin Amiodarone Calcium Channel Blockers Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiotonic Agents |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protective Agents Vasodilator Agents Potassium Channel Blockers Membrane Transport Modulators Sodium Channel Blockers Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 CYP3A Inhibitors |