Withdrawal of Medication in Recovered DCM

NCT02770443 | Terminated

• 1 other identifier: 15-284-MUHC
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized study of medication withdrawal in patients who have recovered LV function in Dilated Cardiomyopathy.

Conditions

Dilated Cardiomyopathy

Keywords

Recovered LVEF; DCM

Outcome Measures

Primary Outcomes (1)

• Number of patients that become symptomatic

  1 year

Secondary Outcomes (1)

• Number of patients that drop EF to <45%

  1 year

Study Arms (2)

Treatment

EXPERIMENTAL

Withdrawal of beta blockers and ACE inhibitors

Drug: withdrawal

control

PLACEBO COMPARATOR

no withdrawal, standard of care

Drug: standard of CARE

Interventions

withdrawal DRUG

withdrawal of beta blocker and ACE inhibitors

Also known as: withdrawal ACE and beta blockers, discontinuation of ACE and beta blockers

Treatment

standard of CARE DRUG

STANDARD OF CARE, NO WITHDRAWAL OF MEDICAL THERAPY

control

Eligibility Criteria

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

You may qualify if:

• Patient diagnosed with dilated cardiomyopathy (DCM) with an initial HFrEF \< 40 % at presentation.
• DCM with recovered LV function to \> or = to 50% documented on 2 ECHO examinations, with the most recent ECHO examination within 1 year of enrolment.
• Time from initial diagnosis of DCM more or equal to 24 month.
• Last hospitalization for decompensated HF \> 1year.

You may not qualify if:

• Ischemic cardiomyopathy
• Other structural pathology such as: Hypertrophic cardiomyopathy, Valvular cardiomyopathy or congenital heart disease.
• Last hospitalization for decompensated HF \< 1year ago.
• Previous sustained ventricle tachycardia or ventricle fibrillation (VF) arrest.

Sponsors & Collaborators

• McGill University: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• Jewish General Hospital: collaborator

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, H3A 3J1, Canada

Location

Related Publications (18)

• Gupta A, Goyal P, Bahl A. Frequency of recovery and relapse in patients with nonischemic dilated cardiomyopathy on guideline-directed medical therapy. Am J Cardiol. 2014 Sep 15;114(6):883-9. doi: 10.1016/j.amjcard.2014.06.021. Epub 2014 Jul 2.

  PMID: 25084692 BACKGROUND

• Moon J, Ko YG, Chung N, Ha JW, Kang SM, Choi EY, Rim SJ. Recovery and recurrence of left ventricular systolic dysfunction in patients with idiopathic dilated cardiomyopathy. Can J Cardiol. 2009 May;25(5):e147-50. doi: 10.1016/s0828-282x(09)70497-0.

  PMID: 19417864 BACKGROUND

• Zhang Y, Guallar E, Blasco-Colmenares E, Butcher B, Norgard S, Nauffal V, Marine JE, Eldadah Z, Dickfeld T, Ellenbogen KA, Tomaselli GF, Cheng A. Changes in Follow-Up Left Ventricular Ejection Fraction Associated With Outcomes in Primary Prevention Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Recipients. J Am Coll Cardiol. 2015 Aug 4;66(5):524-31. doi: 10.1016/j.jacc.2015.05.057.

  PMID: 26227190 BACKGROUND

• Blechman I, Arad M, Nussbaum T, Goldenberg I, Freimark D. Predictors and outcome of sustained improvement in left ventricular function in dilated cardiomyopathy. Clin Cardiol. 2014 Nov;37(11):687-92. doi: 10.1002/clc.22331. Epub 2014 Sep 18.

  PMID: 25236761 BACKGROUND

• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.

  PMID: 23747642 BACKGROUND

• Basuray A, French B, Ky B, Vorovich E, Olt C, Sweitzer NK, Cappola TP, Fang JC. Heart failure with recovered ejection fraction: clinical description, biomarkers, and outcomes. Circulation. 2014 Jun 10;129(23):2380-7. doi: 10.1161/CIRCULATIONAHA.113.006855. Epub 2014 May 5.

  PMID: 24799515 BACKGROUND

• Amos AM, Jaber WA, Russell SD. Improved outcomes in peripartum cardiomyopathy with contemporary. Am Heart J. 2006 Sep;152(3):509-13. doi: 10.1016/j.ahj.2006.02.008.

  PMID: 16923422 BACKGROUND

• Waagstein F, Caidahl K, Wallentin I, Bergh CH, Hjalmarson A. Long-term beta-blockade in dilated cardiomyopathy. Effects of short- and long-term metoprolol treatment followed by withdrawal and readministration of metoprolol. Circulation. 1989 Sep;80(3):551-63. doi: 10.1161/01.cir.80.3.551.

  PMID: 2548768 BACKGROUND

• Morimoto S, Shimizu K, Yamada K, Hiramitsu S, Hishida H. Can beta-blocker therapy be withdrawn from patients with dilated cardiomyopathy? Am Heart J. 1999 Sep;138(3 Pt 1):456-9. doi: 10.1016/s0002-8703(99)70147-x.

  PMID: 10467195 BACKGROUND

• Hopper I, Samuel R, Hayward C, Tonkin A, Krum H. Can medications be safely withdrawn in patients with stable chronic heart failure? systematic review and meta-analysis. J Card Fail. 2014 Jul;20(7):522-32. doi: 10.1016/j.cardfail.2014.04.013. Epub 2014 Apr 18.

  PMID: 24747201 BACKGROUND

• Pflugfelder PW, Baird MG, Tonkon MJ, DiBianco R, Pitt B. Clinical consequences of angiotensin-converting enzyme inhibitor withdrawal in chronic heart failure: a double-blind, placebo-controlled study of quinapril. The Quinapril Heart Failure Trial Investigators. J Am Coll Cardiol. 1993 Nov 15;22(6):1557-63. doi: 10.1016/0735-1097(93)90578-o.

  PMID: 8227822 BACKGROUND

• Nicholls MG, Ikram H, Espiner EA, Maslowski AH, Scandrett MS, Penman T. Hemodynamic and hormonal responses during captopril therapy for heart failure: acute, chronic and withdrawal studies. Am J Cardiol. 1982 Apr 21;49(6):1497-501. doi: 10.1016/0002-9149(82)90367-8.

  PMID: 6803564 BACKGROUND

• Konstam MA, Rousseau MF, Kronenberg MW, Udelson JE, Melin J, Stewart D, Dolan N, Edens TR, Ahn S, Kinan D, et al. Effects of the angiotensin converting enzyme inhibitor enalapril on the long-term progression of left ventricular dysfunction in patients with heart failure. SOLVD Investigators. Circulation. 1992 Aug;86(2):431-8. doi: 10.1161/01.cir.86.2.431.

  PMID: 1638712 BACKGROUND

• Shammas NW, Harris ML, McKinney D, Hauber WJ. Digoxin withdrawal in patients with dilated cardiomyopathy following normalization of ejection fraction with beta blockers. Clin Cardiol. 2001 Dec;24(12):786-7. doi: 10.1002/clc.4960241207.

  PMID: 11768743 BACKGROUND

• Khand AU, Rankin AC, Martin W, Taylor J, Gemmell I, Cleland JG. Carvedilol alone or in combination with digoxin for the management of atrial fibrillation in patients with heart failure? J Am Coll Cardiol. 2003 Dec 3;42(11):1944-51. doi: 10.1016/j.jacc.2003.07.020.

  PMID: 14662257 BACKGROUND

• Cuenca S, Ruiz-Cano MJ, Gimeno-Blanes JR, Jurado A, Salas C, Gomez-Diaz I, Padron-Barthe L, Grillo JJ, Vilches C, Segovia J, Pascual-Figal D, Lara-Pezzi E, Monserrat L, Alonso-Pulpon L, Garcia-Pavia P; Inherited Cardiac Diseases Program of the Spanish Cardiovascular Research Network (Red Investigacion Cardiovascular). Genetic basis of familial dilated cardiomyopathy patients undergoing heart transplantation. J Heart Lung Transplant. 2016 May;35(5):625-35. doi: 10.1016/j.healun.2015.12.014. Epub 2016 Jan 6.

  PMID: 26899768 BACKGROUND

• Sheppard R, Hsich E, Damp J, Elkayam U, Kealey A, Ramani G, Zucker M, Alexis JD, Horne BD, Hanley-Yanez K, Pisarcik J, Halder I, Fett JD, McNamara DM; IPAC Investigators. GNB3 C825T Polymorphism and Myocardial Recovery in Peripartum Cardiomyopathy: Results of the Multicenter Investigations of Pregnancy-Associated Cardiomyopathy Study. Circ Heart Fail. 2016 Mar;9(3):e002683. doi: 10.1161/CIRCHEARTFAILURE.115.002683.

  PMID: 26915373 BACKGROUND

• Ware JS, Li J, Mazaika E, Yasso CM, DeSouza T, Cappola TP, Tsai EJ, Hilfiker-Kleiner D, Kamiya CA, Mazzarotto F, Cook SA, Halder I, Prasad SK, Pisarcik J, Hanley-Yanez K, Alharethi R, Damp J, Hsich E, Elkayam U, Sheppard R, Kealey A, Alexis J, Ramani G, Safirstein J, Boehmer J, Pauly DF, Wittstein IS, Thohan V, Zucker MJ, Liu P, Gorcsan J 3rd, McNamara DM, Seidman CE, Seidman JG, Arany Z; IMAC-2 and IPAC Investigators. Shared Genetic Predisposition in Peripartum and Dilated Cardiomyopathies. N Engl J Med. 2016 Jan 21;374(3):233-41. doi: 10.1056/NEJMoa1505517. Epub 2016 Jan 6.

  PMID: 26735901 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Adrenergic beta-Antagonists; Standard of Care

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Nadia Giannetti, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Cardiology, Director of Heart Function Clinic

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 12, 2016
• Study Start: February 19, 2016
• Primary Completion: August 24, 2017
• Study Completion: November 1, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)