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The Angiotensin Converting Enzyme (ACE) Inhibitor SwitchBack Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by McGill University Health Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01162980
First Posted: July 15, 2010
Last Update Posted: July 15, 2010
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.
Collaborator:
Servier
Information provided by:
McGill University Health Center
  Purpose
ACE inhibitors have been studied extensively in the treatment of heart failure and have been shown to be beneficial in all its stages. Studies with the use of angiotensin receptor blockers (ARBs) in chronic heart failure have not shown equivalent results. Many patients are on an ARB for a variety of reasons. Some of these may have had cough as a symptom of heart failure and not due to medication side effect. According to guidelines, angiotensin converting enzyme inhibitors (ACEi) are still first-line therapy in the treatment of heart failure. As ACEi have been extensively studied showing improvement in morbidity and mortality all patients should be on this treatment unless absolutely contraindicated.

Condition Phase
Heart Failure Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The ACEi SwitchBack Study

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • proportion of patients on ARB who are switched back to ACEi and\ who tolerate ACEi [ Time Frame: 6 months ]
    Patients with heart failure who are on ARB who do not clear contra-indication to ACEi will be switched to an ACei. their tolrance to this will be evaluated


Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
heart failure patients followed in heart failure clinics in Canada
Criteria

Inclusion Criteria:

  • heart failure patients who have indications for ACEi but are currently on ARBs with no absolute contraindications to ACEi
  • patients with an ejection fraction of < or = 35% verified in the last 12 months by echo, angio, or nuc med who are NYHA class I to IV and followed in a heart failure clinic for three months
  • on beta-blockers, unless contra-indicated
  • stable on current meds for 3 months (except dose of diuretics)
  • able to give informed consent

Exclusion Criteria:

  • documented angioedema/anaphylaxis with prior ACEi use
  • documented worsening renal failure, hyperkalemia, cough and gastrointestinal symptoms that are definitely believed to be due to ACEi
  • potassium >5.0 mmol/L
  Contacts and Locations
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): NCT01162980


Locations
Canada, Quebec
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Charlene Barber, BScN    514 934 1934 ext 36764    charlene.barber@muhc.mcgill.ca   
Contact: Nadia Giannetti, MD    514 934 1934 ext 36511    nadia.giannetti@muhc.mcgill.ca   
Principal Investigator: Nadia Giannetti, MD         
Sponsors and Collaborators
McGill University Health Center
Servier
Investigators
Principal Investigator: Nadia Giannetti, MD Royal Victoria Hospital, McGill University Health Centre
  More Information

Responsible Party: Dr Nadia Giannetti, McGill University Health Centre
ClinicalTrials.gov Identifier: NCT01162980     History of Changes
Other Study ID Numbers: 09-150-BMB (SWITCHBACK)
First Submitted: July 13, 2010
First Posted: July 15, 2010
Last Update Posted: July 15, 2010
Last Verified: July 2010

Keywords provided by McGill University Health Center:
ACE inhibitors
ARBs

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action