Heart FailureNCT01128790
Pilot Study of Remote Ischemic Preconditioning in Heart Failure
A study testing Remote ischemic preconditioning in people with Heart Failure and Left Ventricular Dysfunction, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effect of remote ischemic preconditioning on exercise capacity in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Left Ventricular Dysfunction
- What is being tested?
- Remote ischemic preconditioning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LV ejection fraction <40%
- NYHA functional class II-IV
- Non ischemic cardiomyopathy
- Stable
Who cannot join
- recent cardiovascular hospitalization (within last 4 weeks)
- ischemic cardiomyopathy
- diabetes mellitus
- peripheral neuropathy
- ventricular assist device
- contraindications to exercise stress testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Remote Ischemic Preconditioning on Exercise Capacity in Patients With Heart Failure: A Double Blind Randomized Control Trial
The purpose of this study is to determine the effect of remote ischemic preconditioning on exercise capacity in patients with heart failure.
- Conditions
- Heart Failure, Left Ventricular Dysfunction
- Being tested
- Remote ischemic preconditioning, Sham Control
- Keywords
- exercise, remote ischemic preconditioning, heart failure, left ventricular dysfunction
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Left, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningOther
4 cycles x 5 mins upper limb blood pressure cuff inflation 20mmHg above systolic blood pressure
Sham ControlOther
4 cycles x 5mins blood pressure cuff inflation to 10mmHg
| Study group | Role | What they receive |
|---|---|---|
| remote ischemic preconditioning | Experimental | 4 cycles of 5 mins upper limb ischemia induced by blood pressure cuff inflation 20mmHg above systolic blood pressure Receives: Other: Remote ischemic preconditioning |
| Sham control | Sham comparator | 4 x 5 mins of upper limb blood pressure cuff inflation to 10mmHg (non-occlusive) Receives: Other: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise performance - VO2, exercise time, exercise workload, anaerobic threshold
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startOct 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128790
- Sponsor's protocol ID
- 09-0550-BE
- Status last verified
- Dec 2013
- First submitted
- 17 Dec 2009
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40315243McDonald 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.
PubMed 25181050
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Preconditioning on Exercise Capacity in Patients With Heart Failure: A Double Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01128790
- Acronym / sponsor ID
- 09-0550-BE
- Conditions
- Heart Failure, Left Ventricular Dysfunction
- Keywords
- exercise, remote ischemic preconditioning, heart failure, left ventricular dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- Oct 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of remote ischemic preconditioning on exercise capacity in patients with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remote ischemic preconditioning | Experimental | Other: Remote ischemic preconditioning4 cycles of 5 mins upper limb ischemia induced by blood pressure cuff inflation 20mmHg above systolic blood pressure |
| Sham control | Sham comparator | Other: Sham Control4 x 5 mins of upper limb blood pressure cuff inflation to 10mmHg (non-occlusive) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- LV ejection fraction <40%
- NYHA functional class II-IV
- Non ischemic cardiomyopathy
- Stable
Key exclusion criteria (6 listed)
- recent cardiovascular hospitalization (within last 4 weeks)
- ischemic cardiomyopathy
- diabetes mellitus
- peripheral neuropathy
- ventricular assist device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic preconditioning4 cycles x 5 mins upper limb blood pressure cuff inflation 20mmHg above systolic blood pressure | Other | remote ischemic preconditioning |
| Sham Control4 cycles x 5mins blood pressure cuff inflation to 10mmHg | Other | Sham control |
Primary outcome
Exercise performance - VO2, exercise time, exercise workload, anaerobic threshold
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2013.
- Derived from this study: PubMed 40315243Brindle 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.
- Derived from this study: PubMed 25181050McDonald 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic preconditioning in people with Heart Failure and Left Ventricular Dysfunction, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise performance - VO2, exercise time, exercise workload, anaerobic threshold (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01128790, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2013.