Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)

NCT00000556 | Completed Phase 3

• 1 other identifier: 100
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare two standard treatment strategies for atrial fibrillation: ventricular rate control and anticoagulation vs. rhythm control and anticoagulation.

Conditions

Arrhythmia; Atrial Fibrillation; Cardiovascular Diseases; Heart Diseases

Interventions

amiodarone DRUG

sotalol DRUG

propafenone DRUG

flecainide DRUG

quinidine DRUG

moricizine DRUG

disopyramide DRUG

procainamide DRUG

adrenergic beta antagonists DRUG

verapamil DRUG

diltiazem DRUG

digoxin DRUG

catheter ablation PROCEDURE

pacemaker, artificial DEVICE

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

Elderly men and women with atrial fibrillation and other risk factors for stroke.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (28)

• Atrial fibrillation follow-up investigation of rhythm management -- the AFFIRM study design. The Planning and Steering Committees of the AFFIRM study for the NHLBI AFFIRM investigators. Am J Cardiol. 1997 May 1;79(9):1198-202.

  PMID: 9164885 BACKGROUND

• Wyse DG. The AFFIRM trial: main trial and substudies-what can We expect? J Interv Card Electrophysiol. 2000 Jan;4 Suppl 1:171-6. doi: 10.1023/a:1009815606734.

  PMID: 10590505 BACKGROUND

• Waldo AL. Management of atrial fibrillation: the need for AFFIRMative action. AFFIRM investigators. Atrial Fibrillation Follow-up Investigation of Rhythm Management. Am J Cardiol. 1999 Sep 15;84(6):698-700. doi: 10.1016/s0002-9149(99)00419-1. No abstract available.

  PMID: 10498142 BACKGROUND

• AFFIRM Investigators. Atrial Fibrillation Follow-up Investigation of Rhythm Management. Baseline characteristics of patients with atrial fibrillation: the AFFIRM Study. Am Heart J. 2002 Jun;143(6):991-1001. doi: 10.1067/mhj.2002.122875.

  PMID: 12075254 BACKGROUND

• Epstein AE, Vidaillet H, Greene HL, Curtis AB, Ellenbogen KA, Simmons T, Mickel M. Frequency of symptomatic atrial fibrillation in patients enrolled in the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study. J Cardiovasc Electrophysiol. 2002 Jul;13(7):667-71. doi: 10.1046/j.1540-8167.2002.00667.x.

  PMID: 12139289 BACKGROUND

• Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD; Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1825-33. doi: 10.1056/NEJMoa021328.

  PMID: 12466506 BACKGROUND

• AFFIRM First Antiarrhythmic Drug Substudy Investigators. Maintenance of sinus rhythm in patients with atrial fibrillation: an AFFIRM substudy of the first antiarrhythmic drug. J Am Coll Cardiol. 2003 Jul 2;42(1):20-9. doi: 10.1016/s0735-1097(03)00559-x.

  PMID: 12849654 BACKGROUND

• Corley SD, Epstein AE, DiMarco JP, Domanski MJ, Geller N, Greene HL, Josephson RA, Kellen JC, Klein RC, Krahn AD, Mickel M, Mitchell LB, Nelson JD, Rosenberg Y, Schron E, Shemanski L, Waldo AL, Wyse DG; AFFIRM Investigators. Relationships between sinus rhythm, treatment, and survival in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Study. Circulation. 2004 Mar 30;109(12):1509-13. doi: 10.1161/01.CIR.0000121736.16643.11. Epub 2004 Mar 8.

  PMID: 15007003 BACKGROUND

• Steinberg JS, Sadaniantz A, Kron J, Krahn A, Denny DM, Daubert J, Campbell WB, Havranek E, Murray K, Olshansky B, O'Neill G, Sami M, Schmidt S, Storm R, Zabalgoitia M, Miller J, Chandler M, Nasco EM, Greene HL. Analysis of cause-specific mortality in the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study. Circulation. 2004 Apr 27;109(16):1973-80. doi: 10.1161/01.CIR.0000118472.77237.FA. Epub 2004 Mar 29.

  PMID: 15051639 BACKGROUND

• Cooper HA, Bloomfield DA, Bush DE, Katcher MS, Rawlins M, Sacco JD, Chandler M; AFFIRM Investigators. Relation between achieved heart rate and outcomes in patients with atrial fibrillation (from the Atrial Fibrillation Follow-up Investigation of Rhythm Management [AFFIRM] Study). Am J Cardiol. 2004 May 15;93(10):1247-53. doi: 10.1016/j.amjcard.2004.01.069.

  PMID: 15135698 BACKGROUND

• Kaufman ES, Zimmermann PA, Wang T, Dennish GW 3rd, Barrell PD, Chandler ML, Greene HL; Atrial Fibrillation Follow-up Investigation of Rhythm Management investigators. Risk of proarrhythmic events in the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study: a multivariate analysis. J Am Coll Cardiol. 2004 Sep 15;44(6):1276-82. doi: 10.1016/j.jacc.2004.06.052.

  PMID: 15364332 BACKGROUND

• Marshall DA, Levy AR, Vidaillet H, Fenwick E, Slee A, Blackhouse G, Greene HL, Wyse DG, Nichol G, O'Brien BJ; AFFIRM and CORE Investigators. Cost-effectiveness of rhythm versus rate control in atrial fibrillation. Ann Intern Med. 2004 Nov 2;141(9):653-61. doi: 10.7326/0003-4819-141-9-200411020-00005.

  PMID: 15520421 BACKGROUND

• Shelton RJ. The AFFIRM study: approaches to control rate in atrial fibrillation. J Am Coll Cardiol. 2004 Dec 21;44(12):2418; author reply 2418-9. doi: 10.1016/j.jacc.2004.09.025. No abstract available.

  PMID: 15607416 BACKGROUND

• Jenkins LS, Brodsky M, Schron E, Chung M, Rocco T Jr, Lader E, Constantine M, Sheppard R, Holmes D, Mateski D, Floden L, Prasun M, Greene HL, Shemanski L. Quality of life in atrial fibrillation: the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study. Am Heart J. 2005 Jan;149(1):112-20. doi: 10.1016/j.ahj.2004.03.065.

  PMID: 15660042 BACKGROUND

• Olshansky B, Sami M, Rubin A, Kostis J, Shorofsky S, Slee A, Greene HL; NHLBI AFFIRM Investigators. Use of amiodarone for atrial fibrillation in patients with preexisting pulmonary disease in the AFFIRM study. Am J Cardiol. 2005 Feb 1;95(3):404-5. doi: 10.1016/j.amjcard.2004.09.044.

  PMID: 15670555 BACKGROUND

• Cooper HA, Sacco J, Solomon AJ, Feld GK, Leman R, Wilber D; AFFIRM Investigators. Relation of initial resting ventricular rate to the ability to achieve and maintain normal sinus rhythm in patients with atrial fibrillation. Am J Cardiol. 2005 Mar 1;95(5):597-602. doi: 10.1016/j.amjcard.2004.10.037.

  PMID: 15721098 BACKGROUND

• Curtis AB, Seals AA, Safford RE, Slater W, Tullo NG, Vidaillet H, Wilber DJ, Slee A. Clinical factors associated with abandonment of a rate-control or a rhythm-control strategy for the management of atrial fibrillation in the AFFIRM study. Am Heart J. 2005 Feb;149(2):304-8. doi: 10.1016/j.ahj.2004.08.012.

  PMID: 15846269 BACKGROUND

• Murray KT, Rottman JN, Arbogast PG, Shemanski L, Primm RK, Campbell WB, Solomon AJ, Olgin JE, Wilson MJ, Dimarco JP, Beckman KJ, Dennish G, Naccarelli GV, Ray WA; AFFIRM Investigators. Inhibition of angiotensin II signaling and recurrence of atrial fibrillation in AFFIRM. Heart Rhythm. 2004 Dec;1(6):669-75. doi: 10.1016/j.hrthm.2004.08.008.

  PMID: 15851238 BACKGROUND

• Wyse DG, Slee A, Epstein AE, Gersh BJ, Rocco T Jr, Vidaillet H, Volgman A, Weiss R, Shemanski L, Greene HL; AFFIRM Investigators. Alternative endpoints for mortality in studies of patients with atrial fibrillation: the AFFIRM study experience. Heart Rhythm. 2004 Nov;1(5):531-7. doi: 10.1016/j.hrthm.2004.07.007.

  PMID: 15851214 BACKGROUND

• Sherman DG, Kim SG, Boop BS, Corley SD, Dimarco JP, Hart RG, Haywood LJ, Hoyte K, Kaufman ES, Kim MH, Nasco E, Waldo AL; National Heart, Lung, and Blood Institute AFFIRM Investigators. Occurrence and characteristics of stroke events in the Atrial Fibrillation Follow-up Investigation of Sinus Rhythm Management (AFFIRM) study. Arch Intern Med. 2005 May 23;165(10):1185-91. doi: 10.1001/archinte.165.10.1185.

  PMID: 15911734 BACKGROUND

• Olshansky B, Heller EN, Mitchell LB, Chandler M, Slater W, Green M, Brodsky M, Barrell P, Greene HL. Are transthoracic echocardiographic parameters associated with atrial fibrillation recurrence or stroke? Results from the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) study. J Am Coll Cardiol. 2005 Jun 21;45(12):2026-33. doi: 10.1016/j.jacc.2005.03.020.

  PMID: 15963405 BACKGROUND

• DiMarco JP, Flaker G, Waldo AL, Corley SD, Greene HL, Safford RE, Rosenfeld LE, Mitrani G, Nemeth M; AFFIRM Investigators. Factors affecting bleeding risk during anticoagulant therapy in patients with atrial fibrillation: observations from the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study. Am Heart J. 2005 Apr;149(4):650-6. doi: 10.1016/j.ahj.2004.11.015.

  PMID: 15990748 BACKGROUND

• Flaker GC, Belew K, Beckman K, Vidaillet H, Kron J, Safford R, Mickel M, Barrell P; AFFIRM Investigators. Asymptomatic atrial fibrillation: demographic features and prognostic information from the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study. Am Heart J. 2005 Apr;149(4):657-63. doi: 10.1016/j.ahj.2004.06.032.

  PMID: 15990749 BACKGROUND

• Curtis AB, Gersh BJ, Corley SD, DiMarco JP, Domanski MJ, Geller N, Greene HL, Kellen JC, Mickel M, Nelson JD, Rosenberg Y, Schron E, Shemanski L, Waldo AL, Wyse DG; AFFIRM Investigators. Clinical factors that influence response to treatment strategies in atrial fibrillation: the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study. Am Heart J. 2005 Apr;149(4):645-9. doi: 10.1016/j.ahj.2004.09.038.

  PMID: 15990747 BACKGROUND

• Olshansky B, Rosenfeld LE, Warner AL, Solomon AJ, O'Neill G, Sharma A, Platia E, Feld GK, Akiyama T, Brodsky MA, Greene HL; AFFIRM Investigators. The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study: approaches to control rate in atrial fibrillation. J Am Coll Cardiol. 2004 Apr 7;43(7):1201-8. doi: 10.1016/j.jacc.2003.11.032.

  PMID: 15063430 BACKGROUND

• Chung MK, Shemanski L, Sherman DG, Greene HL, Hogan DB, Kellen JC, Kim SG, Martin LW, Rosenberg Y, Wyse DG; AFFIRM Investigators. Functional status in rate- versus rhythm-control strategies for atrial fibrillation: results of the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Functional Status Substudy. J Am Coll Cardiol. 2005 Nov 15;46(10):1891-9. doi: 10.1016/j.jacc.2005.07.040. Epub 2005 Oct 21.

  PMID: 16286177 BACKGROUND

• Proietti M, Romiti GF, Olshansky B, Lip GYH. Systolic Blood Pressure Visit-to-Visit Variability and Major Adverse Outcomes in Atrial Fibrillation: The AFFIRM Study (Atrial Fibrillation Follow-Up Investigation of Rhythm Management). Hypertension. 2017 Nov;70(5):949-958. doi: 10.1161/HYPERTENSIONAHA.117.10106. Epub 2017 Oct 3.

  PMID: 28974568 DERIVED

• Saksena S, Slee A, Waldo AL, Freemantle N, Reynolds M, Rosenberg Y, Rathod S, Grant S, Thomas E, Wyse DG. Cardiovascular outcomes in the AFFIRM Trial (Atrial Fibrillation Follow-Up Investigation of Rhythm Management). An assessment of individual antiarrhythmic drug therapies compared with rate control with propensity score-matched analyses. J Am Coll Cardiol. 2011 Nov 1;58(19):1975-85. doi: 10.1016/j.jacc.2011.07.036.

  PMID: 22032709 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Cardiovascular Diseases; Heart Diseases

Interventions

Amiodarone; Sotalol; Propafenone; Flecainide; Quinidine; Moricizine; Disopyramide; Procainamide; Adrenergic beta-Antagonists; Verapamil; Diltiazem; Digoxin; Catheter Ablation; Pacemaker, Artificial

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Propiophenones; Ketones; Piperidines; Heterocyclic Compounds, 1-Ring; Cinchona Alkaloids; Alkaloids; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Phenothiazines; Sulfur Compounds; Morpholines; Oxazines; Heterocyclic Compounds, 3-Ring; Pyridines; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Phenethylamines; Ethylamines; Benzazepines; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• H. Greene

  Statistics and Epidemiology Research Corporation (S.E.R.C.)

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: March 1, 1995
• Study Completion: September 1, 2002
• Last Updated: March 25, 2016

Record last verified: 2005-11