Pilot Study of Remote Ischemic Preconditioning in Heart Failure

NCT ID: NCT01128790

Last Updated: 2013-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-06-30

Brief Summary

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

Detailed Description

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Conditions

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Heart Failure Left Ventricular Dysfunction

Keywords

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exercise remote ischemic preconditioning heart failure left ventricular dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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remote ischemic preconditioning

4 cycles of 5 mins upper limb ischemia induced by blood pressure cuff inflation 20mmHg above systolic blood pressure

Group Type EXPERIMENTAL

Remote ischemic preconditioning

Intervention Type OTHER

4 cycles x 5 mins upper limb blood pressure cuff inflation 20mmHg above systolic blood pressure

Sham control

4 x 5 mins of upper limb blood pressure cuff inflation to 10mmHg (non-occlusive)

Group Type SHAM_COMPARATOR

Sham Control

Intervention Type OTHER

4 cycles x 5mins blood pressure cuff inflation to 10mmHg

Interventions

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Remote ischemic preconditioning

4 cycles x 5 mins upper limb blood pressure cuff inflation 20mmHg above systolic blood pressure

Intervention Type OTHER

Sham Control

4 cycles x 5mins blood pressure cuff inflation to 10mmHg

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 40315243 (View on PubMed)

McDonald 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.

Reference Type DERIVED
PMID: 25181050 (View on PubMed)

Other Identifiers

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09-0550-BE

Identifier Type: -

Identifier Source: org_study_id