Heart FailurePhase 4TIBI-HFNCT01100918
Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy
A Phase 4 study testing BiV ICD and ICD in people with Heart Failure, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Currently the main selection tool for Cardiac Resynchronisation Therapy (CRT) is the QRS duration on the surface echocardiography (ECG) which has been shown to be a poor predictor of response. We sought to evaluate the use of tissue Doppler (TDI) assessment of dyssynchrony in prediction of response to CRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- BiV ICD and ICD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2007to Dec 2010
- Phase
- Phase 4
- 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
- Patients must have an indication for ICD therapy
- Heart failure of any aetiology with evidence of left ventricular (LV) systolic dysfunction with LV ejection fraction < 35% and LV cavity dilatation (end diastolic dimension > 55 mm)
- NYHA Class III/IV symptoms of heart failure despite optimal medical therapy
- QRS duration ≥120ms
Who cannot join
- Reversible cause of heart failure such as ongoing ischaemia amenable to revascularisation or treatable valvular disease
- Requirement for ventricular pacing due to atrioventricular block.
- Limited life expectancy (< 6 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy in Heart Failure
Currently the main selection tool for Cardiac Resynchronisation Therapy (CRT) is the QRS duration on the surface echocardiography (ECG) which has been shown to be a poor predictor of response. We sought to evaluate the use of tissue Doppler (TDI) assessment of dyssynchrony in prediction of response to CRT.
The hypothesis is that the presence of mechanical dyssynchrony (measured using TDI echocardiography) successfully identifies heart failure patients who will respond to CRT. Conversely, the absence of mechanical dyssynchrony is associated with a low/no response to CRT.
This is a three arm study. Group 1 comprises patients with dyssynchrony on TDI who are implanted with a biventricular ICD whereas Group 2 patients comprise patients who have no dyssynchrony. Group 2 patients are randomised 1:1 to either receive a biventricular ICD (2a) or an ICD (2b). All patients undergo a NYHA class assessment, a cardiopulmonary exercise test, and an echocardiogram at baseline and at 6 months follow up. Baseline and 6 months findings will be compared in all three groups.
- Conditions
- Heart Failure
- Being tested
- BiV ICD, ICD
- Keywords
- Cardiac resynchronisation therapy, Tissue Doppler Imaging, Dyssynchrony
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiV ICDDevice
Biventricular ICD
ICDDevice
Implantable Defibrillator
| Study group | Role | What they receive |
|---|---|---|
| 1: Dyssynchrony positive | Active comparator | Not described Receives: Device: BiV ICD |
| 2a: Dyssynchrony negative | Active comparator | Not described Receives: Device: BiV ICD |
| 2b: Dyssynchrony negative | Active comparator | Not described Receives: Device: ICD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary Exercise Testing - changes in Peak VO2 from baseline to 6 months
Measured: 6 months
Secondary outcomes (3)
Change in New York Heart Association (NYHA) class from baseline to 6 months
Measured: 6 months
Change in Quality-of-Life score from baseline to 6 months
Measured: 6 months
Echocardiography - changes in left ventricular (LV) volume and dimensions, calculated ejection fractions and in severity of MR
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startFeb 2007
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Schilling, MD, FRCP, Principal investigator, Barts and the London NHS Trust, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100918
- Sponsor's protocol ID
- 004844BLT
- Acronym
- TIBI-HF
- Status last verified
- Aug 2014
- First submitted
- 8 Apr 2010
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy in Heart Failure
- ClinicalTrials.gov ID
- NCT01100918
- Acronym / sponsor ID
- TIBI-HF / 004844BLT
- Conditions
- Heart Failure
- Keywords
- Cardiac resynchronisation therapy, Tissue Doppler Imaging, Dyssynchrony
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Apr 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.
Currently the main selection tool for Cardiac Resynchronisation Therapy (CRT) is the QRS duration on the surface echocardiography (ECG) which has been shown to be a poor predictor of response. We sought to evaluate the use of tissue Doppler (TDI) assessment of dyssynchrony in prediction of response to CRT.
The hypothesis is that the presence of mechanical dyssynchrony (measured using TDI echocardiography) successfully identifies heart failure patients who will respond to CRT. Conversely, the absence of mechanical dyssynchrony is associated with a low/no response to CRT.
This is a three arm study. Group 1 comprises patients with dyssynchrony on TDI who are implanted with a biventricular ICD whereas Group 2 patients comprise patients who have no dyssynchrony. Group 2 patients are randomised 1:1 to either receive a biventricular ICD (2a) or an ICD (2b). All patients undergo a NYHA class assessment, a cardiopulmonary exercise test, and an echocardiogram at baseline and at 6 months follow up. Baseline and 6 months findings will be compared in all three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: Dyssynchrony positive | Active comparator | Device: BiV ICD |
| 2a: Dyssynchrony negative | Active comparator | Device: BiV ICD |
| 2b: Dyssynchrony negative | Active comparator | Device: ICD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must have an indication for ICD therapy
- Heart failure of any aetiology with evidence of left ventricular (LV) systolic dysfunction with LV ejection fraction < 35% and LV cavity dilatation (end diastolic dimension > 55 mm)
- NYHA Class III/IV symptoms of heart failure despite optimal medical therapy
- QRS duration ≥120ms
Key exclusion criteria (3 listed)
- Reversible cause of heart failure such as ongoing ischaemia amenable to revascularisation or treatable valvular disease
- Requirement for ventricular pacing due to atrioventricular block.
- Limited life expectancy (< 6 months)
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 |
|---|---|---|
| BiV ICDBiventricular ICD | Device | 1: Dyssynchrony positive, 2a: Dyssynchrony negative |
| ICDImplantable Defibrillator | Device | 2b: Dyssynchrony negative |
Primary outcome
Cardiopulmonary Exercise Testing - changes in Peak VO2 from baseline to 6 months
Time frame: 6 months
3 secondary outcomes
Change in New York Heart Association (NYHA) class from baseline to 6 months
Time frame: 6 months
Change in Quality-of-Life score from baseline to 6 months
Time frame: 6 months
Echocardiography - changes in left ventricular (LV) volume and dimensions, calculated ejection fractions and in severity of MR
Time frame: 6 months
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 13 Aug 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.
Richard Schilling, MD, FRCP principal investigator
Barts and the London NHS Trust, Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BiV ICD and ICD in people with Heart Failure, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 3 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 13 Aug 2014. 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 United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cardiopulmonary Exercise Testing - changes in Peak VO2 from baseline to 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2014.