|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01128790 |
|
Date of registration:
|
17/12/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Pilot Study of Remote Ischemic Preconditioning in Heart Failure
|
|
Scientific title:
|
Effect of Remote Ischemic Preconditioning on Exercise Capacity in Patients With Heart Failure: A Double Blind Randomized Control Trial |
|
Date of first enrolment:
|
October 2009 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01128790 |
|
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
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Michael A McDonald, MD |
|
Address:
|
|
|
Telephone:
|
416-340-4800 |
|
Email:
|
michael.mcdonald@uhn.on.ca |
|
Affiliation:
|
|
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Heart Failure
|
|
Left Ventricular Dysfunction
|
|
Intervention(s)
|
|
Other: Remote ischemic preconditioning
|
|
Other: Sham Control
|
|
Primary Outcome(s)
|
|
Exercise performance - VO2, exercise time, exercise workload, anaerobic threshold
[Time Frame: 1 week]
|
|
Secondary ID(s)
|
|
09-0550-BE
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|