Heart Failure, SystolicNARROW-CRTNCT01577446
Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy (NARROW CRT)
A study testing cardiac resynchronization therapy in people with Heart Failure, Systolic, run by Ospedale Santa Maria di Loreto Mare at 1 site in Italy.
Trial summary
Current recommendations require a QRS duration of ≥120ms as a condition for prescribing cardiac resynchronization therapy (CRT). This study was designed to test the hypothesis that patients with heart failure of ischemic origin, current indications for defibrillator implantation and QRS <120ms may benefit from CRT in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- cardiac resynchronization therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2008to Aug 2012
- 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
- NHYA class II-III heart failure
- ischemic cardiomyopathy
- ejection fraction of 35% or less
- QRS interval of 120ms or less
- evidence of mechanical dyssynchrony as measured on echocardiography
Who cannot join
- conventional indication for cardiac pacing
- persistent atrial fibrillation
- life expectancy lower than 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy
Current recommendations require a QRS duration of ≥120ms as a condition for prescribing cardiac resynchronization therapy (CRT). This study was designed to test the hypothesis that patients with heart failure of ischemic origin, current indications for defibrillator implantation and QRS <120ms may benefit from CRT in the presence of marked mechanical dyssynchrony.
- Conditions
- Heart Failure, Systolic
- Being tested
- cardiac resynchronization therapy
- Keywords
- CRT, heart failure, narrow QRS, dyssynchrony
- Medical subject headings
- Heart Failure, Systolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac resynchronization therapyProcedure or surgery
Implantation of a CRT defibrillator with a standard right atrial, right ventricular defibrillator and left ventricular leads
| Study group | Role | What they receive |
|---|---|---|
| CRT | Experimental | The CRT group undergoes implantation of a CRT defibrillator Receives: Procedure: cardiac resynchronization therapy |
| no-CRT | No intervention | The no-CRT group receives a dual-chamber defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart failure clinical composite score
Patients are classified according to a score, which assigns subjects to one of three response groups - improved, worsened, or unchanged. Patients are judged to be worsened if they died or were hospitalized because of worsening heart failure (at any time during the 12 months), or demonstrated worsening in NYHA functional class at their 12-month visit. Patients are judged to be improved if they had not worsened and had demonstrated improvement in NYHA functional class at 12 months. Patients who are not worsened or improved are classified as unchanged.
Measured: 12 months
Secondary outcomes (1)
time to the first heart failure hospitalization or death
Kaplan-Meier analysis is used to analyze time to death or first heart failure hospitalization
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startJan 2008
- Primary completionAug 2012
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 Failure, SystolicStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Santa Maria di Loreto Mare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmine Muto, Ospedale Santa Maria di Loreto Mare
- Investigators
- Carmine Muto, MD, Study chair, Ospedale Santa Maria di Loreto Mare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577446
- Sponsor's protocol ID
- LM-002
- Acronym
- NARROW-CRT
- Status last verified
- Oct 2016
- First submitted
- 11 Apr 2012
- Last updated
- 18 Oct 2016
- Results posted
- No
Publications
Muto C, Solimene F, Gallo P, Nastasi M, La Rosa C, Calvanese R, Iengo R, Canciello M, Sangiuolo R, Diemberger I, Ciardiello C, Tuccillo B. A randomized study of cardiac resynchronization therapy defibrillator versus dual-chamber implantable cardioverter-defibrillator in ischemic cardiomyopathy with narrow QRS: the NARROW-CRT study. Circ Arrhythm Electrophysiol. 2013 Jun;6(3):538-45. doi: 10.1161/CIRCEP.113.000135. Epub 2013 Apr 16.
PubMed 23592833
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT01577446
- Acronym / sponsor ID
- NARROW-CRT / LM-002
- Conditions
- Heart Failure, Systolic
- Keywords
- CRT, heart failure, narrow QRS, dyssynchrony
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ospedale Santa Maria di Loreto MareUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Aug 2012 (actual)
- First posted
- 13 Apr 2012 (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.
Current recommendations require a QRS duration of ≥120ms as a condition for prescribing cardiac resynchronization therapy (CRT). This study was designed to test the hypothesis that patients with heart failure of ischemic origin, current indications for defibrillator implantation and QRS <120ms may benefit from CRT in the presence of marked mechanical dyssynchrony.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT | Experimental | Procedure: cardiac resynchronization therapyThe CRT group undergoes implantation of a CRT defibrillator |
| no-CRT | No intervention | –The no-CRT group receives a dual-chamber defibrillator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- NHYA class II-III heart failure
- ischemic cardiomyopathy
- ejection fraction of 35% or less
- QRS interval of 120ms or less
- evidence of mechanical dyssynchrony as measured on echocardiography
Key exclusion criteria (3 listed)
- conventional indication for cardiac pacing
- persistent atrial fibrillation
- life expectancy lower than 1 year
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 |
|---|---|---|
| cardiac resynchronization therapyImplantation of a CRT defibrillator with a standard right atrial, right ventricular defibrillator and left ventricular leads | Procedure or surgery | CRT |
Primary outcome
heart failure clinical composite score
Time frame: 12 months
Patients are classified according to a score, which assigns subjects to one of three response groups - improved, worsened, or unchanged. Patients are judged to be worsened if they died or were hospitalized because of worsening heart failure (at any time during the 12 months), or demonstrated worsening in NYHA functional class at their 12-month visit. Patients are judged to be improved if they had not worsened and had demonstrated improvement in NYHA functional class at 12 months. Patients who are not worsened or improved are classified as unchanged.
1 secondary outcome
time to the first heart failure hospitalization or death
Time frame: up to 30 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 18 Oct 2016.
- Derived from this study: PubMed 23592833Muto C, Solimene F, Gallo P, Nastasi M, La Rosa C, Calvanese R, Iengo R, Canciello M, Sangiuolo R, Diemberger I, Ciardiello C, Tuccillo B. A randomized study of cardiac resynchronization therapy defibrillator versus dual-chamber implantable cardioverter-defibrillator in ischemic cardiomyopathy with narrow QRS: the NARROW-CRT study. Circ Arrhythm Electrophysiol. 2013 Jun;6(3):538-45. doi: 10.1161/CIRCEP.113.000135. Epub 2013 Apr 16.
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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.
Carmine Muto, MD study chair
Ospedale Santa Maria di Loreto Mare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac resynchronization therapy in people with Heart Failure, Systolic, run by Ospedale Santa Maria di Loreto Mare at 1 site in Italy.
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 5 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 18 Oct 2016. 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 Italy. 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.
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?
heart failure clinical composite score (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 NCT01577446, 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 18 Oct 2016.