Pilot Study of Remote Ischemic Preconditioning in Heart Failure
Effect of Remote Ischemic Preconditioning on Exercise Capacity in Patients With Heart Failure: A Double Blind Randomized Control Trial
1 other identifier
interventional
22
1 country
1
Brief Summary
The purpose of this study is to determine the effect of remote ischemic preconditioning on exercise capacity in patients with heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 17, 2009
CompletedFirst Posted
Study publicly available on registry
May 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedDecember 23, 2013
December 1, 2013
1.7 years
December 17, 2009
December 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exercise performance - VO2, exercise time, exercise workload, anaerobic threshold
1 week
Study Arms (2)
remote ischemic preconditioning
EXPERIMENTAL4 cycles of 5 mins upper limb ischemia induced by blood pressure cuff inflation 20mmHg above systolic blood pressure
Sham control
SHAM COMPARATOR4 x 5 mins of upper limb blood pressure cuff inflation to 10mmHg (non-occlusive)
Interventions
4 cycles x 5 mins upper limb blood pressure cuff inflation 20mmHg above systolic blood pressure
Eligibility Criteria
You may qualify if:
- LV ejection fraction \<40%
- NYHA functional class II-IV
- Non ischemic cardiomyopathy
- Stable
You may not qualify if:
- recent cardiovascular hospitalization (within last 4 weeks)
- ischemic cardiomyopathy
- diabetes mellitus
- peripheral neuropathy
- ventricular assist device
- contraindications to exercise stress testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Health Network, Torontolead
- The Hospital for Sick Childrencollaborator
Study Sites (1)
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Related Publications (2)
Brindle HE, Tetsa-Tata D, Edwards T, Choi EM, Kasonia K, Aboubacar S, Mambula G, Kavunga-Membo H, Grais R, Johnson J, Bausch DG, Muyembe-Tamfum JJ, Ama IS, Lees S, Watson-Jones D, Camacho A, Roberts CH. Using an analogue-digital hybrid clinical data management platform during a two-dose preventive Ebola virus vaccine trial in Goma, the Democratic Republic of the Congo. PLOS Glob Public Health. 2025 May 2;5(5):e0004487. doi: 10.1371/journal.pgph.0004487. eCollection 2025.
PMID: 40315243DERIVEDMcDonald MA, Braga JR, Li J, Manlhiot C, Ross HJ, Redington AN. A randomized pilot trial of remote ischemic preconditioning in heart failure with reduced ejection fraction. PLoS One. 2014 Sep 2;9(9):e105361. doi: 10.1371/journal.pone.0105361. eCollection 2014.
PMID: 25181050DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2009
First Posted
May 24, 2010
Study Start
October 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
December 23, 2013
Record last verified: 2013-12