The Angiotensin Converting Enzyme (ACE) Inhibitor SwitchBack Study

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. Identifier: NCT01162980
Recruitment Status : Unknown
Verified July 2010 by McGill University Health Center.
Recruitment status was:  Recruiting
First Posted : July 15, 2010
Last Update Posted : July 15, 2010
Information provided by:
McGill University Health Center

Brief Summary:
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 or disease
Heart Failure

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The ACEi SwitchBack Study
Study Start Date : July 2010
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

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 identifier (NCT number): NCT01162980

Canada, Quebec
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Charlene Barber, BScN    514 934 1934 ext 36764   
Contact: Nadia Giannetti, MD    514 934 1934 ext 36511   
Principal Investigator: Nadia Giannetti, MD         
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: Nadia Giannetti, MD Royal Victoria Hospital, McGill University Health Centre

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

Keywords provided by McGill University Health Center:
ACE inhibitors

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