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The Angiotensin Converting Enzyme (ACE) Inhibitor SwitchBack Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Servier
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01162980
First received: July 13, 2010
Last updated: July 14, 2010
Last verified: July 2010
History of Changes
  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:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Nadia Giannetti, McGill University Health Centre
ClinicalTrials.gov Identifier: NCT01162980     History of Changes
Other Study ID Numbers: 09-150-BMB (SWITCHBACK)
Study First Received: July 13, 2010
Last Updated: July 14, 2010
Health Authority: Canada: Ethics Review Committee

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013