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Trial record 47 of 157 for:    Idiopathic Dilated Cardiomyopathy

Withdrawal of Medication in Recovered DCM (WrecEF)

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ClinicalTrials.gov Identifier: NCT02770443
Recruitment Status : Unknown
Verified May 2016 by Nadia Giannetti, McGill University.
Recruitment status was:  Recruiting
First Posted : May 12, 2016
Last Update Posted : May 12, 2016
Sponsor:
Collaborators:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Jewish General Hospital
Information provided by (Responsible Party):
Nadia Giannetti, McGill University

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

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Drug: withdrawal Drug: standard of CARE Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Withdrawal of Beta- Blockers and ACE Inhibitors After Left Ventricular Systolic Function Recovery in Patient With Dilated Cardiomyopathy: A Randomized Control Trial.
Study Start Date : February 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : July 2018


Arm Intervention/treatment
Experimental: Treatment
Withdrawal of beta blockers and ACE inhibitors
Drug: withdrawal
withdrawal of beta blocker and ACE inhibitors
Other Names:
  • withdrawal ACE and beta blockers
  • discontinuation of ACE and beta blockers

Placebo Comparator: control
no withdrawal, standard of care
Drug: standard of CARE
STANDARD OF CARE, NO WITHDRAWAL OF MEDICAL THERAPY




Primary Outcome Measures :
  1. Number of patients that remain clinically in NYHA Class I [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of patients that maintain LVEF > or = 50% [ Time Frame: 1 year ]
  2. Average BNP level compared to baseline BNP level [ Time Frame: 1 year ]


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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:

  1. Patient diagnosed with dilated cardiomyopathy (DCM) with an initial HFrEF < 40 % at presentation.
  2. 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.
  3. Time from initial diagnosis of DCM more or equal to 24 month.
  4. Last hospitalization for decompensated HF > 1year.

Exclusion criteria:

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

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): NCT02770443


Contacts
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Contact: Abeer M Bakhsh, MD 19056164503 abeer.bakhsh@mail.mcgill.ca
Contact: Kimberley V Kotar, Bsc. 5149341934 ext 35661 kimberley.kotar@muhc.mcgill.ca

Locations
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Canada, Quebec
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 3J1
Contact: Abeer M Bakhsh, MD    9056164503    abeer.bakhsh@mail.mcgill.ca   
Contact: Kimberley V Kotar, Bsc    5149341934 ext 35661    kimberley.kotar@muhc.mcgill.ca   
Principal Investigator: Nadia Giannetti, MD         
Sponsors and Collaborators
McGill University
McGill University Health Centre/Research Institute of the McGill University Health Centre
Jewish General Hospital
Investigators
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Principal Investigator: Nadia Giannetti, MD McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications:

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Responsible Party: Nadia Giannetti, Chief, Division of Cardiology, Director of Heart Function Clinic, McGill University
ClinicalTrials.gov Identifier: NCT02770443     History of Changes
Other Study ID Numbers: 15-284-MUHC
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nadia Giannetti, McGill University:
Recovered LVEF
DCM
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly
Adrenergic beta-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors