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Pilot Study of Remote Ischemic Preconditioning in Heart Failure

Primary Purpose

Heart Failure, Left Ventricular Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Remote ischemic preconditioning
Sham Control
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring exercise, remote ischemic preconditioning, heart failure, left ventricular dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

remote ischemic preconditioning

Sham control

Arm Description

4 cycles of 5 mins upper limb ischemia induced by blood pressure cuff inflation 20mmHg above systolic blood pressure

4 x 5 mins of upper limb blood pressure cuff inflation to 10mmHg (non-occlusive)

Outcomes

Primary Outcome Measures

Exercise performance - VO2, exercise time, exercise workload, anaerobic threshold

Secondary Outcome Measures

Full Information

First Posted
December 17, 2009
Last Updated
December 20, 2013
Sponsor
University Health Network, Toronto
Collaborators
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01128790
Brief Title
Pilot Study of Remote Ischemic Preconditioning in Heart Failure
Official Title
Effect of Remote Ischemic Preconditioning on Exercise Capacity in Patients With Heart Failure: A Double Blind Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Left Ventricular Dysfunction
Keywords
exercise, remote ischemic preconditioning, heart failure, left ventricular dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
remote ischemic preconditioning
Arm Type
Experimental
Arm Description
4 cycles of 5 mins upper limb ischemia induced by blood pressure cuff inflation 20mmHg above systolic blood pressure
Arm Title
Sham control
Arm Type
Sham Comparator
Arm Description
4 x 5 mins of upper limb blood pressure cuff inflation to 10mmHg (non-occlusive)
Intervention Type
Other
Intervention Name(s)
Remote ischemic preconditioning
Intervention Description
4 cycles x 5 mins upper limb blood pressure cuff inflation 20mmHg above systolic blood pressure
Intervention Type
Other
Intervention Name(s)
Sham Control
Intervention Description
4 cycles x 5mins blood pressure cuff inflation to 10mmHg
Primary Outcome Measure Information:
Title
Exercise performance - VO2, exercise time, exercise workload, anaerobic threshold
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25181050
Citation
McDonald MA, Braga JR, Li J, Manlhiot C, Ross HJ, Redington AN. A randomized pilot trial of remote ischemic preconditioning in heart failure with reduced ejection fraction. PLoS One. 2014 Sep 2;9(9):e105361. doi: 10.1371/journal.pone.0105361. eCollection 2014.
Results Reference
derived

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Pilot Study of Remote Ischemic Preconditioning in Heart Failure

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