The Angiotensin Converting Enzyme (ACE) Inhibitor SwitchBack Study

NCT01162980 | Unknown

• 1 other identifier: 09-150-BMB (SWITCHBACK)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

ACE inhibitors; ARBs

Outcome Measures

Primary Outcomes (1)

• proportion of patients on ARB who are switched back to ACEi and\ who tolerate ACEi

  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

  6 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

heart failure patients followed in heart failure clinics in Canada

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Servier: collaborator

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Nadia Giannetti, MD

  Royal Victoria Hospital, McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 15, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 15, 2010

Record last verified: 2010-07

Locations

CA (1)