The Angiotensin Converting Enzyme (ACE) Inhibitor SwitchBack Study

Heart Failure Clinical Trial

Official title:

The ACEi SwitchBack Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01162980
• Other study ID #: 09-150-BMB (SWITCHBACK)
• Status: Recruiting
• Phase: Phase 4
• First received: July 13, 2010
• Last updated: July 14, 2010
• Start date: July 2010
• Est. completion date: July 2012

Study information

• Verified date: July 2010
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	Servier

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes