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Pilot Study of Remote Ischemic Preconditioning in Heart Failure

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ClinicalTrials.gov Identifier: NCT01128790
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : December 23, 2013
Sponsor:
Collaborator:
The Hospital for Sick Children
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
The purpose of this study is to determine the effect of remote ischemic preconditioning on exercise capacity in patients with heart failure.

Condition or disease Intervention/treatment Phase
Heart Failure Left Ventricular Dysfunction Other: Remote ischemic preconditioning Other: Sham Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Remote Ischemic Preconditioning on Exercise Capacity in Patients With Heart Failure: A Double Blind Randomized Control Trial
Study Start Date : October 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: remote ischemic preconditioning
4 cycles of 5 mins upper limb ischemia induced by blood pressure cuff inflation 20mmHg above systolic blood pressure
Other: Remote ischemic preconditioning
4 cycles x 5 mins upper limb blood pressure cuff inflation 20mmHg above systolic blood pressure
Sham Comparator: Sham control
4 x 5 mins of upper limb blood pressure cuff inflation to 10mmHg (non-occlusive)
Other: Sham Control
4 cycles x 5mins blood pressure cuff inflation to 10mmHg



Primary Outcome Measures :
  1. Exercise performance - VO2, exercise time, exercise workload, anaerobic threshold [ Time Frame: 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LV ejection fraction <40%
  • NYHA functional class II-IV
  • Non ischemic cardiomyopathy
  • Stable

Exclusion Criteria:

  • recent cardiovascular hospitalization (within last 4 weeks)
  • ischemic cardiomyopathy
  • diabetes mellitus
  • peripheral neuropathy
  • ventricular assist device
  • contraindications to exercise stress testing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128790


Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
The Hospital for Sick Children

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01128790     History of Changes
Other Study ID Numbers: 09-0550-BE
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: December 2013

Keywords provided by University Health Network, Toronto:
exercise
remote ischemic preconditioning
heart failure
left ventricular dysfunction

Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases