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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01128790
Other study ID # 09-0550-BE
Secondary ID
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


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
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