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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
July 13, 2010
July 15, 2010
July 15, 2010
July 2010
January 2012   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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The Angiotensin Converting Enzyme (ACE) Inhibitor SwitchBack Study
The ACEi SwitchBack Study
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
heart failure patients followed in heart failure clinics in Canada
Heart Failure
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
July 2012
January 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01162980
09-150-BMB (SWITCHBACK)
No
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Dr Nadia Giannetti, McGill University Health Centre
McGill University Health Center
Servier
Principal Investigator: Nadia Giannetti, MD Royal Victoria Hospital, McGill University Health Centre
McGill University Health Center
July 2010