Heart FailurePhase 3BESTNCT01439529
ECG Optimization of CRT: Evaluation of Mid-term Response
A Phase 3 study testing Device programming: nominal and Programming optimization by QRS in people with Heart Failure, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
New simpler methods to optimize cardiac resynchronization therapy (CRT) are being evaluated, such as the use of the electrocardiogram. In this prospective, double-blind, study, the investigators will evaluate: Primary endpoint: To compare the clinical response to CRT in patients with the programming optimized by QRS… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Device programming: nominal and Programming optimization by QRS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2009to Sep 2017
- Phase
- Phase 3
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patient refusal.
- Cardiopathy with a reversible cause.
- Prevision of heart transplantation.
- Atrial fibrillation.
- Complete AV block.
- AV delay >250 ms.
Show all 9Show fewer
- Right bundle branch block.
- Severe peripheral vascular disease.
- Other diseases with < 1 year life expectancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Response to Cardiac Resynchronization Therapy by Electrocardiogram: an Assessment of Medium-term Response
New simpler methods to optimize cardiac resynchronization therapy (CRT) are being evaluated, such as the use of the electrocardiogram.
In this prospective, double-blind, study, the investigators will evaluate:
Read more
Primary endpoint: To compare the clinical response to CRT in patients with the programming optimized by QRS versus the nominal suggested by the device.
Secondary endpoints:
- To compare cardiac remodeling in patients with the programming optimized by QRS versus the nominal suggested by the device.
- To evaluate the degree of asynchrony in both groups (nominal versus optimization by QRS) with respect to the intrinsic rhythm.
- To evaluate the echocardiographic improvement in left ventricular (LV) filling in both groups.
- To evaluate the differences in the optimal atrioventricular (AV) delay with atrial sensing or atrial pacing.
For that, 180 patients with an indication for CRT will be randomized to nominal programming of the device or optimization by the electrocardiogram for a narrower QRS. A clinical and echocardiographic evaluation will be done at baseline, 6 and 12 months.
- Conditions
- Heart Failure
- Being tested
- Device programming: nominal, Programming optimization by QRS
- Keywords
- Cardiac, Resynchronization, Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device programming: nominalOther
CRT device is programmed to nominal values
Programming optimization by QRSOther
CRT device is programmed by QRS optimization
| Study group | Role | What they receive |
|---|---|---|
| Nominal | Active comparator | CRT device is programmed with the nominal values. Receives: Other: Device programming: nominal |
| Narrow QRS | Experimental | CRT device is programmed by QRS optimization Receives: Other: Programming optimization by QRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Clinical response: survival without heart transplantation or death and >10% increased distance in the 6MWT.
Measured: 12 months
Secondary outcomes (2)
Echocardiographic response
Echocardiographic response: >15% decrease in LV end-systolic volume and survival without heart transplantation or death.
Measured: 12 months
Pacing/sensing AV delay difference
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startApr 2009
- Primary completionSep 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Hospital Clinic of BarcelonaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arbelo, Hospital Clinic of Barcelona
- Investigators
- Elena Arbelo, MD, PhD, Study chair, Hospital Clinic Universitari de BarcelonaLluís Mont, MD, PhD, Study director, Hospital Clínic Universitari de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439529
- Sponsor's protocol ID
- BEST
- Acronym
- BEST
- Status last verified
- Aug 2018
- First submitted
- 19 Sep 2011
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Trucco E, Tolosana JM, Arbelo E, Doltra A, Castel MA, Benito E, Borras R, Guasch E, Vidorreta S, Vidal B, Montserrat S, Sitges M, Berruezo A, Brugada J, Mont L. Improvement of Reverse Remodeling Using Electrocardiogram Fusion-Optimized Intervals in Cardiac Resynchronization Therapy: A Randomized Study. JACC Clin Electrophysiol. 2018 Feb;4(2):181-189. doi: 10.1016/j.jacep.2017.11.020. Epub 2018 Feb 1.
PubMed 29749935
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Response to Cardiac Resynchronization Therapy by Electrocardiogram: an Assessment of Medium-term Response
- ClinicalTrials.gov ID
- NCT01439529
- Acronym / sponsor ID
- BEST / BEST
- Conditions
- Heart Failure
- Keywords
- Cardiac, Resynchronization, Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 23 Sep 2011 (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.
New simpler methods to optimize cardiac resynchronization therapy (CRT) are being evaluated, such as the use of the electrocardiogram.
In this prospective, double-blind, study, the investigators will evaluate:
Primary endpoint: To compare the clinical response to CRT in patients with the programming optimized by QRS versus the nominal suggested by the device.
Secondary endpoints:
- To compare cardiac remodeling in patients with the programming optimized by QRS versus the nominal suggested by the device.
- To evaluate the degree of asynchrony in both groups (nominal versus optimization by QRS) with respect to the intrinsic rhythm.
- To evaluate the echocardiographic improvement in left ventricular (LV) filling in both groups.
- To evaluate the differences in the optimal atrioventricular (AV) delay with atrial sensing or atrial pacing.
For that, 180 patients with an indication for CRT will be randomized to nominal programming of the device or optimization by the electrocardiogram for a narrower QRS. A clinical and echocardiographic evaluation will be done at baseline, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nominal | Active comparator | Other: Device programming: nominalCRT device is programmed with the nominal values. |
| Narrow QRS | Experimental | Other: Programming optimization by QRSCRT device is programmed by QRS optimization |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Patient refusal.
- Cardiopathy with a reversible cause.
- Prevision of heart transplantation.
- Atrial fibrillation.
- Complete AV block.
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 |
|---|---|---|
| Device programming: nominalCRT device is programmed to nominal values | Other | Nominal |
| Programming optimization by QRSCRT device is programmed by QRS optimization | Other | Narrow QRS |
Primary outcome
Clinical response
Time frame: 12 months
Clinical response: survival without heart transplantation or death and >10% increased distance in the 6MWT.
2 secondary outcomes
Echocardiographic response
Time frame: 12 months
Pacing/sensing AV delay difference
Time frame: 12 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 2 Aug 2018.
- Derived from this study: PubMed 29749935Trucco E, Tolosana JM, Arbelo E, Doltra A, Castel MA, Benito E, Borras R, Guasch E, Vidorreta S, Vidal B, Montserrat S, Sitges M, Berruezo A, Brugada J, Mont L. Improvement of Reverse Remodeling Using Electrocardiogram Fusion-Optimized Intervals in Cardiac Resynchronization Therapy: A Randomized Study. JACC Clin Electrophysiol. 2018 Feb;4(2):181-189. doi: 10.1016/j.jacep.2017.11.020. Epub 2018 Feb 1.
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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.
Elena Arbelo, MD, PhD study chair
Hospital Clinic Universitari de Barcelona
Lluís Mont, MD, PhD study director
Hospital Clínic Universitari de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Device programming: nominal and Programming optimization by QRS in people with Heart Failure, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 0 inclusion and 9 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 2 Aug 2018. 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 Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Clinical response (time frame: 12 months). 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 NCT01439529, which also lists 1 linked publication.
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 2 Aug 2018.