Reversal of Cardiomyopathy by Suppression of Frequent Premature Ventricular Complexes

NCT01566344 | Unknown

• 2 other identifiers: NL37355.068.11METC 11-2-076
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Frequent monomorphic premature ventricular complexes (PVCs) may cause a cardiomyopathy (CMP) that is reversible by suppression of the ectopic focus. This study investigates whether PVC suppression therapy can improve cardiac function and clinical condition of patients with idiopathic or ischemic CMP and frequent monomorphic PVCs. For this purpose, patients will be randomized to either one of two treatment strategies: 1) conventional heart failure therapy plus PVC suppression therapy, consisting of RFCA as primary treatment and Amiodarone as secondary treatment in case of unsuccessful RFCA, or 2) conventional heart failure therapy without PVC suppression therapy.

Conditions

Heart Diseases; Cardiac Arrhythmias; Ventricular Premature Complexes; Systolic Heart Failure; Cardiomyopathies

Keywords

Premature Ventricular Complex; Cardiomyopathy; Left ventricular dysfunction; Catheter Ablation; Anti-Arrhythmic Agents; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular ejection fraction (LVEF)

  Baseline and 6 months

Secondary Outcomes (10)

• Change in left ventricular end systolic diameter (LVESD)

  Baseline and 6 months

• Change in left ventricular end diastolic diameter (LVEDD)

  Baseline and 6 months

• Change in left ventricular end systolic volume (LVESV)

  Baseline and 6 months

• Change in left ventricular end diastolic volume (LVEDV)

  Baseline and 6 months

• Change in New York Heart Association (NYHA) functional class

  Baseline and 6 months

Study Arms (2)

Routine heart failure therapy plus PVC suppression therapy

EXPERIMENTAL

Other: PVC suppression therapy

Routine heart failure therapy

NO INTERVENTION

Interventions

PVC suppression therapy OTHER

Conventional heart failure therapy plus radiofrequency catheter ablation of PVCs as primary treatment and Amiodarone (tablets, loading dose of 600 mg per day for 4 weeks and 200 mg per day afterwards for at least 12 months) as secondary treatment in case of unsuccessful catheter ablation.

Routine heart failure therapy plus PVC suppression therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LVEF \< 50% without identifiable cause (idiopathic) or post-infarction, \> 6 months.
• Optimal conventional heart failure therapy \> 3 months.
• Frequent monomorphic PVCs on Holter monitoring.
• Frequent = more than 15% of all QRS complexes are PVCs.
• Monomorphic = more than 75% of PVCs have the same morphology.
• Greater than 18 years of age.
• Willing and capable of giving informed consent.

You may not qualify if:

• Other causes of LV systolic dysfunction:
• Significant valvular disease.
• Untreated hypertension (blood pressure \> 140 mmHg).
• Primary CMP (HCM, ARVC, LVNC, myocarditis, stress, peripartum).
• Secondary CMP (infiltrative, storage, toxic, neuromuscular/neurological, autoimmune).
• Electrocardiographic PVC characteristics suggestive of a focal origin not accessible by percutaneous approach.
• Sustained supra-ventricular arrhythmia.
• Evidence of significant CAD (\>70% stenosis of a coronary artery) on coronary angiogram (CAG) or coronary CT necessitating revascularization (PCI / CABG) in the foreseeable future.
• Signs of current myocardial ischemia on ECG (dynamic STT segments) or during exercise testing (significant ST segment depression/elevation).
• Myocardial infarction within the last 6 calender months prior to enrollment.
• PCI / CABG within the last 6 calender months prior to enrollment.
• Physical status not allowing electrophysiological study (e.g. pregnancy or severe peripheral artery disease)
• Presence of any disease, other than the patient's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6202 AZ, Netherlands

RECRUITING

Related Publications (12)

• Bogun F, Crawford T, Reich S, Koelling TM, Armstrong W, Good E, Jongnarangsin K, Marine JE, Chugh A, Pelosi F, Oral H, Morady F. Radiofrequency ablation of frequent, idiopathic premature ventricular complexes: comparison with a control group without intervention. Heart Rhythm. 2007 Jul;4(7):863-7. doi: 10.1016/j.hrthm.2007.03.003. Epub 2007 Mar 12.

  PMID: 17599667 BACKGROUND

• Takemoto M, Yoshimura H, Ohba Y, Matsumoto Y, Yamamoto U, Mohri M, Yamamoto H, Origuchi H. Radiofrequency catheter ablation of premature ventricular complexes from right ventricular outflow tract improves left ventricular dilation and clinical status in patients without structural heart disease. J Am Coll Cardiol. 2005 Apr 19;45(8):1259-65. doi: 10.1016/j.jacc.2004.12.073.

  PMID: 15837259 BACKGROUND

• Baman TS, Lange DC, Ilg KJ, Gupta SK, Liu TY, Alguire C, Armstrong W, Good E, Chugh A, Jongnarangsin K, Pelosi F Jr, Crawford T, Ebinger M, Oral H, Morady F, Bogun F. Relationship between burden of premature ventricular complexes and left ventricular function. Heart Rhythm. 2010 Jul;7(7):865-9. doi: 10.1016/j.hrthm.2010.03.036. Epub 2010 Mar 27.

  PMID: 20348027 BACKGROUND

• Yokokawa M, Kim HM, Good E, Chugh A, Pelosi F Jr, Alguire C, Armstrong W, Crawford T, Jongnarangsin K, Oral H, Morady F, Bogun F. Relation of symptoms and symptom duration to premature ventricular complex-induced cardiomyopathy. Heart Rhythm. 2012 Jan;9(1):92-5. doi: 10.1016/j.hrthm.2011.08.015. Epub 2011 Aug 17.

  PMID: 21855522 BACKGROUND

• Sarrazin JF, Labounty T, Kuhne M, Crawford T, Armstrong WF, Desjardins B, Good E, Jongnarangsin K, Chugh A, Oral H, Pelosi F, Morady F, Bogun F. Impact of radiofrequency ablation of frequent post-infarction premature ventricular complexes on left ventricular ejection fraction. Heart Rhythm. 2009 Nov;6(11):1543-9. doi: 10.1016/j.hrthm.2009.08.004. Epub 2009 Aug 5.

  PMID: 19879531 BACKGROUND

• Blaauw Y, Pison L, van Opstal JM, Dennert RM, Heesen WF, Crijns HJ. Reversal of ventricular premature beat induced cardiomyopathy by radiofrequency catheter ablation. Neth Heart J. 2010 Oct;18(10):493-8. doi: 10.1007/BF03091821.

  PMID: 20978594 BACKGROUND

• Niwano S, Wakisaka Y, Niwano H, Fukaya H, Kurokawa S, Kiryu M, Hatakeyama Y, Izumi T. Prognostic significance of frequent premature ventricular contractions originating from the ventricular outflow tract in patients with normal left ventricular function. Heart. 2009 Aug;95(15):1230-7. doi: 10.1136/hrt.2008.159558. Epub 2009 May 7.

  PMID: 19429571 BACKGROUND

• Kanei Y, Friedman M, Ogawa N, Hanon S, Lam P, Schweitzer P. Frequent premature ventricular complexes originating from the right ventricular outflow tract are associated with left ventricular dysfunction. Ann Noninvasive Electrocardiol. 2008 Jan;13(1):81-5. doi: 10.1111/j.1542-474X.2007.00204.x.

  PMID: 18234010 BACKGROUND

• Duffee DF, Shen WK, Smith HC. Suppression of frequent premature ventricular contractions and improvement of left ventricular function in patients with presumed idiopathic dilated cardiomyopathy. Mayo Clin Proc. 1998 May;73(5):430-3. doi: 10.1016/S0025-6196(11)63724-5.

  PMID: 9581582 BACKGROUND

• Yarlagadda RK, Iwai S, Stein KM, Markowitz SM, Shah BK, Cheung JW, Tan V, Lerman BB, Mittal S. Reversal of cardiomyopathy in patients with repetitive monomorphic ventricular ectopy originating from the right ventricular outflow tract. Circulation. 2005 Aug 23;112(8):1092-7. doi: 10.1161/CIRCULATIONAHA.105.546432. Epub 2005 Aug 15.

  PMID: 16103234 BACKGROUND

• Taieb JM, Maury P, Shah D, Duparc A, Galinier M, Delay M, Morice R, Alfares A, Barnay C. Reversal of dilated cardiomyopathy by the elimination of frequent left or right premature ventricular contractions. J Interv Card Electrophysiol. 2007 Nov;20(1-2):9-13. doi: 10.1007/s10840-007-9157-2. Epub 2007 Oct 17.

  PMID: 17940858 BACKGROUND

• Kennedy HL, Whitlock JA, Sprague MK, Kennedy LJ, Buckingham TA, Goldberg RJ. Long-term follow-up of asymptomatic healthy subjects with frequent and complex ventricular ectopy. N Engl J Med. 1985 Jan 24;312(4):193-7. doi: 10.1056/NEJM198501243120401.

  PMID: 2578212 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Arrhythmias, Cardiac; Ventricular Premature Complexes; Heart Failure, Systolic; Cardiomyopathies; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Complexes, Premature; Cardiac Conduction System Disease; Heart Failure; Ventricular Dysfunction

Study Officials

• Yuri Blaauw, MD, PhD

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

• Harry JGM Crijns, MD, PhD

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Masih Mafi Rad, MD

CONTACT

+31-43-3871613; masih.mafirad@mumc.nl

Yuri Blaauw, MD, PhD

CONTACT

+31-43-3877095; yuri.blaauw@mumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

NL (1)