Pilot Study of Remote Ischemic Preconditioning in Heart Failure

This study has been completed.
Sponsor:
Collaborator:
The Hospital for Sick Children
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01128790
First received: December 17, 2009
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Heart Failure
Left Ventricular Dysfunction
Other: Remote ischemic preconditioning
Other: Sham Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Exercise performance - VO2, exercise time, exercise workload, anaerobic threshold [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128790

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

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01128790     History of Changes
Other Study ID Numbers: 09-0550-BE
Study First Received: December 17, 2009
Last Updated: December 20, 2013
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on September 18, 2014