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
Information provided by:
McGill University Health Center Identifier:
First received: July 13, 2010
Last updated: July 14, 2010
Last verified: July 2010

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

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)

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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Dr Nadia Giannetti, McGill University Health Centre 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

Additional relevant MeSH terms:
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors processed this record on October 02, 2015