Pilot Study of Remote Ischemic Preconditioning in Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128790
• Other study ID #: 09-0550-BE
• Status: Completed
• Phase: N/A
• First received: December 17, 2009
• Last updated: December 20, 2013
• Start date: October 2009
• Est. completion date: June 2011

Study information

• Verified date: December 2013
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Left Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Other:
• Remote ischemic preconditioning
4 cycles x 5 mins upper limb blood pressure cuff inflation 20mmHg above systolic blood pressure
• Sham Control
4 cycles x 5mins blood pressure cuff inflation to 10mmHg

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise performance - VO2, exercise time, exercise workload, anaerobic threshold		1 week	No