Pilot Study of Remote Ischemic Preconditioning in Heart Failure

December 20, 2013 updated by: University Health Network, Toronto

Effect of Remote Ischemic Preconditioning on Exercise Capacity in Patients With Heart Failure: A Double Blind Randomized Control Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • Toronto General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exercise performance - VO2, exercise time, exercise workload, anaerobic threshold
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

May 21, 2010

First Posted (Estimate)

May 24, 2010

Study Record Updates

Last Update Posted (Estimate)

December 23, 2013

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0550-BE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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