The Angiotensin Converting Enzyme (ACE) Inhibitor SwitchBack Study

NCT ID: NCT01162980

Last Updated: 2010-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Servier

INDUSTRY

Sponsor Role collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Responsible Party

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McGill University Health Centre

Principal Investigators

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Nadia Giannetti, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Victoria Hospital, McGill University Health Centre

Locations

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Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Charlene Barber, BScN

Role: primary

514 934 1934 ext. 36764

Nadia Giannetti, MD

Role: backup

514 934 1934 ext. 36511

Other Identifiers

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09-150-BMB (SWITCHBACK)

Identifier Type: -

Identifier Source: org_study_id

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