Recruiting

ACE Inhibitor

Sponsor:

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

Code:

NCT01162980

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT01162980

Start date

Jul, 2010

Status verified date

Jul, 2010

Completion date

Jul, 2012

Anticipated

Primary completion date

Jan, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • proportion of patients on ARB who are switched back to ACEi and\ who tolerate ACEi [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada, H3A 1A1

Contacts

Charlene Barber, BScN

514 934 1934charlene.barber@muhc.mcgill.ca

Nadia Giannetti, MD

514 934 1934nadia.giannetti@muhc.mcgill.ca

Principal Investigator:

Nadia Giannetti, MD

More Information

Sponsor

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

Last update posted

Jul 15, 2010

Last verified

Jul, 2010

Keywords

  • ACE inhibitors
  • ARBs

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2010-07-15.