Heart FailureNICD-CRTNCT02454439
Assessment of Cardiac Resynchronization Therapy in Patients With Wide QRS and Non-specific Intraventricular Conduction Delay: a Randomized Trial
A study testing CRT implantation in people with Heart Failure, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of the NICD-CRT study is to assess whether CRT may be clinically beneficial in HF patients with NICD and reduced ejection fraction on 12-month HF status. In effect, the effectiveness of cardiac resynchronization therapy in heart failure (HF) with reduced ejection fraction patients with non specific… 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?
- CRT implantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Jul 2024
- 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
- Patients over 18 years' old
- NYHA class II to IV ambulatory
- QRS duration > 130 ms
- Patients with sinus rhythm
- LVEF < 35%
- QRS morphology: NICD according to the AHA/ACCF/HRS Recommendations (non-LBBB and non-RBBB):
Show all 20Show fewer
- Not broad notched or slurred R wave in leads I, aVL, V5 and V6;
- Presence of a Q wave in leads I, V5, V6;
- No rsr', rsR' or rSR' pattern in leads V1 or V2.
- Life expectancy expected to exceed one year with a good functional status
- Optimal pharmacological therapy of heart failure according to clinician
- Non inclusion criteria :
- Inability to understand nor decline the study,
- Impaired mobility,
- Unable to fill out questionnaire independently,
- Patients with permanent atrial fibrillation,
- Pregnant women,
- Dependant adult,
- Patients minor,
- Life expectancy < 1 year due to other causes than HF.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Gérald GOUBY, 04 73 75 49 62, ggouby@chu-clermontferrand.fr
Romain ESCHALIER
About this study
The aim of the NICD-CRT study is to assess whether CRT may be clinically beneficial in HF patients with NICD and reduced ejection fraction on 12-month HF status.
In effect, the effectiveness of cardiac resynchronization therapy in heart failure (HF) with reduced ejection fraction patients with non specific intraventricular conduction delay (NICD) has never been confirmed even if it is recommended.
Read more
At the moment, no dedicated study has already been performed to assess the benefit of CRT in patients with NICD. Results from CRT therapy are contradictory in this patient group and have only been obtained from subgroup analysis. Some of them don't show clinical benefit but others show a benefit in term of an end-diastolic and/or end-systolic left ventricular volume (decrease of the size and the volumes of left ventricule).
The AHA/ACCF guidelines, published in 2005 and updated in 2009, considered only QRS duration (≥120 ms) for the indication of CRT implantation, without any consideration for the type of conduction disorder (i.e. LBBB vs. non-LBBB), current updated 2012 ACCF/AHA/HRS guidelines, consider QRS morphology (i.e. LBBB) as the first step for CRT candidate selection in addition to QRS duration (>150 ms). Indications for resynchronization have been restricted since indication of CRT in non-LBBB patients (e.g. NICD) is only a class IIa (>150 ms, only in NYHA III and ambulatory IV; level of evidence A). The same modifications have been applied between 2011 and 2013 in the European guidelines. None is known about patients with NICD and QRS > 130 ms.
Read the detailed description
This is a pilot, prospective, controlled, two-parallel arm, randomized, double-blind design and multicentric clinical trial comparing a CRT-D or CRT-P ON group vs. CRT-D or CRT-P OFF group in HF with reduced ejection fraction patients with NICD.
- Patients will be included in thirteen sites in France(Clermont-Ferrand University Hospital, Côte Basque Hospital, Bordeaux University Hospital, Saint-Augustin Clinic, Limoges University Hospital, Grenoble University Hospital, Nantes University Hospital, Nantes New Clinic, Rennes University Hospital, Saint-Etienne University Hospital, Tours University Hospital, Toulouse University Hospital, Georges Pompidou European Hospital) and two sites in the Netherlands (Maastricht University Hospital and Radboud University Medical Center)
- At baseline a preimplantation evaluation is performed: clinical examination, ECG, six minute walk test, biology analysis, quality of life assessment, echocardiography, peak oxygen consumption.
- At 6 months, evaluation of efficacy which is the secondary assessment criteria:
- Quality of life: Minnesota Living With Heart Failure Questionnary: MLWHFQ) : improvement of at least 20 points
- Functionnal capacity :
- NYHA classification reduction ≥ 1 class,
- 6-minute walk test improvement of at least 10 % in distance,
- Peak oxygen consumption increased by 1.0 ml/kg/minNYHA response to CRT is the primary endpoint. It is a composite primary endpoint, including modification of: Quality of Life Score (MINNESOTA scale), NYHA functional status , 6-minute walk test and volume of the left ventricle.
- Percentage of hospitalizations for HF, for cardiovascular reasons and for all causes Decrease >15% in end-diastolic and/or end-systolic volumes of the left ventricle.
- At 12 months, comparison of the proportion of improved, unchanged and worsend patients (Packer Score) in both group which is the primary endpoint and new evaluation of the CRT efficacy (same as 6 months)and comparison of the death and percentage of hospitalization in both group which is the primary endpoint.
- Conditions
- Heart Failure
- Being tested
- CRT implantation
- Keywords
- Heart Failure with reduced ejection fraction (<35%), Cardiac Resynchronisation Therapy, Non specific intraventricular conduction, Efficacy, Life expectancy expected to exceed one year with a good functional status, QRS morphology : NICD according to the AHA/ACCF/HRS Recommendations (non-LBBB and non-RBBB):, QRS duration > 130 ms
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT implantationOther
| Study group | Role | What they receive |
|---|---|---|
| CRT-D or CRT-P ON | Experimental | This is a pilot, prospective, controlled, two-parallel arm, randomized, double-blind design and multicentric clinical trial comparing a CRT-D or CRT-P ON group vs. CRT-D or CRT-P OFF group in HF with reduced ejection fraction patients with NICD. Receives: Other: CRT implantation |
| CRT-D or CRT-P OFF | Other | This is a pilot, prospective, controlled, two-parallel arm, randomized, double-blind design and multicentric clinical trial comparing a CRT-D or CRT-P ON group vs. CRT-D or CRT-P OFF group in HF with reduced ejection fraction patients with NICD. Receives: Other: CRT implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of 2 clinical endpoints combined (12 months all-cause deaths and percentage of hospitalizations for HF at 12 months) combined using an average z-score.
According to z-score
Measured: at 12 months
Secondary outcomes (6)
Evaluation of efficacy, analysis of 12- month deaths
HF, cardiovascular and all causes deaths
Measured: at 6 and 12 months
Evaluation of efficacy, analysis of - Quality-of-life questionnaires
Minnesota Living With Heart Failure Questionnaire: MLWHFQ): improvement of at least 20 points
Measured: at 6 and 12 months
Evaluation of efficacy, analysis of Functional capacity
NYHA classification reduction ≥ 1 class, 6-minute walk test improvement of at least 10 % in distance, Peak oxygen consumption increased by 1.0 ml/kg/min
Measured: at 6 and 12 months
Evaluation of efficacy, analysis of Percentage of hospitalizations for HF
Measured: at 6 and 12 months
Evaluation of efficacy, analysis of left ventricule volume by echocardiography transthoracic
Decrease >15% in end-diastolic and/or end-systolic volumes of the left ventricle
Measured: at 6 and 12 months
Evaluation of efficacy, Packer score
The proportion of improved, unchanged and worsened patients in both groups. Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment (or both) of a prespecified magnitude but did not experience any major adverse clinical events during the course of the trial.
Patients are considered worse if they experienced a major clinical event during the planned duration of double-blind treatment or reported worsening of their NYHA class or global assessment at the final visit.
Patients are considered unchanged if they are neither improved nor worse.
Measured: at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2023 (estimated)
- Study completionJul 2024 (estimated)
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 University Hospital, Clermont-FerrandThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Romain ESCHALIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454439
- Sponsor's protocol ID
- CHU-0233
- Other IDs
- 2014-A01848-39
- Acronym
- NICD-CRT
- Status last verified
- Sep 2015
- First submitted
- 22 May 2015
- Last updated
- 28 Jun 2021
- Results posted
- No
Publications
Eschalier R, Ploux S, Pereira B, Clementy N, Da Costa A, Defaye P, Garrigue S, Gourraud JB, Gras D, Guy-Moyat B, Leclercq C, Mondoly P, Bordachar P. Assessment of cardiac resynchronisation therapy in patients with wide QRS and non-specific intraventricular conduction delay: rationale and design of the multicentre randomised NICD-CRT study. BMJ Open. 2016 Nov 11;6(11):e012383. doi: 10.1136/bmjopen-2016-012383.
PubMed 27836874
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiac Resynchronization Therapy in Patients With Wide QRS and Non-specific Intraventricular Conduction Delay: a Randomized Trial
- ClinicalTrials.gov ID
- NCT02454439
- Acronym / sponsor ID
- NICD-CRT / CHU-0233
- Conditions
- Heart Failure
- Keywords
- Heart Failure with reduced ejection fraction (<35%), Cardiac Resynchronisation Therapy, Non specific intraventricular conduction, Efficacy, Life expectancy expected to exceed one year with a good functional status, QRS morphology : NICD according to the AHA/ACCF/HRS Recommendations (non-LBBB and non-RBBB):, QRS duration > 130 ms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Jul 2015
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 27 May 2015 (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 aim of the NICD-CRT study is to assess whether CRT may be clinically beneficial in HF patients with NICD and reduced ejection fraction on 12-month HF status.
In effect, the effectiveness of cardiac resynchronization therapy in heart failure (HF) with reduced ejection fraction patients with non specific intraventricular conduction delay (NICD) has never been confirmed even if it is recommended.
At the moment, no dedicated study has already been performed to assess the benefit of CRT in patients with NICD. Results from CRT therapy are contradictory in this patient group and have only been obtained from subgroup analysis. Some of them don't show clinical benefit but others show a benefit in term of an end-diastolic and/or end-systolic left ventricular volume (decrease of the size and the volumes of left ventricule).
The AHA/ACCF guidelines, published in 2005 and updated in 2009, considered only QRS duration (≥120 ms) for the indication of CRT implantation, without any consideration for the type of conduction disorder (i.e. LBBB vs. non-LBBB), current updated 2012 ACCF/AHA/HRS guidelines, consider QRS morphology (i.e. LBBB) as the first step for CRT candidate selection in addition to QRS duration (>150 ms). Indications for resynchronization have been restricted since indication of CRT in non-LBBB patients (e.g. NICD) is only a class IIa (>150 ms, only in NYHA III and ambulatory IV; level of evidence A). The same modifications have been applied between 2011 and 2013 in the European guidelines. None is known about patients with NICD and QRS > 130 ms.
Detailed description
This is a pilot, prospective, controlled, two-parallel arm, randomized, double-blind design and multicentric clinical trial comparing a CRT-D or CRT-P ON group vs. CRT-D or CRT-P OFF group in HF with reduced ejection fraction patients with NICD.
- Patients will be included in thirteen sites in France(Clermont-Ferrand University Hospital, Côte Basque Hospital, Bordeaux University Hospital, Saint-Augustin Clinic, Limoges University Hospital, Grenoble University Hospital, Nantes University Hospital, Nantes New Clinic, Rennes University Hospital, Saint-Etienne University Hospital, Tours University Hospital, Toulouse University Hospital, Georges Pompidou European Hospital) and two sites in the Netherlands (Maastricht University Hospital and Radboud University Medical Center)
- At baseline a preimplantation evaluation is performed: clinical examination, ECG, six minute walk test, biology analysis, quality of life assessment, echocardiography, peak oxygen consumption.
- At 6 months, evaluation of efficacy which is the secondary assessment criteria:
- Quality of life: Minnesota Living With Heart Failure Questionnary: MLWHFQ) : improvement of at least 20 points
- Functionnal capacity :
- NYHA classification reduction ≥ 1 class,
- 6-minute walk test improvement of at least 10 % in distance,
- Peak oxygen consumption increased by 1.0 ml/kg/minNYHA response to CRT is the primary endpoint. It is a composite primary endpoint, including modification of: Quality of Life Score (MINNESOTA scale), NYHA functional status , 6-minute walk test and volume of the left ventricle.
- Percentage of hospitalizations for HF, for cardiovascular reasons and for all causes Decrease >15% in end-diastolic and/or end-systolic volumes of the left ventricle.
- At 12 months, comparison of the proportion of improved, unchanged and worsend patients (Packer Score) in both group which is the primary endpoint and new evaluation of the CRT efficacy (same as 6 months)and comparison of the death and percentage of hospitalization in both group which is the primary endpoint.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT-D or CRT-P ON | Experimental | Other: CRT implantationThis is a pilot, prospective, controlled, two-parallel arm, randomized, double-blind design and multicentric clinical trial comparing a CRT-D or CRT-P ON group vs. CRT-D or CRT-P OFF group in HF with reduced ejection fraction patients with NICD. |
| CRT-D or CRT-P OFF | Other | Other: CRT implantationThis is a pilot, prospective, controlled, two-parallel arm, randomized, double-blind design and multicentric clinical trial comparing a CRT-D or CRT-P ON group vs. CRT-D or CRT-P OFF group in HF with reduced ejection fraction patients with NICD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients over 18 years' old
- NYHA class II to IV ambulatory
- QRS duration > 130 ms
- Patients with sinus rhythm
- LVEF < 35%
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CRT implantation | Other | CRT-D or CRT-P OFF, CRT-D or CRT-P ON |
Primary outcome
Composite of 2 clinical endpoints combined (12 months all-cause deaths and percentage of hospitalizations for HF at 12 months) combined using an average z-score.
Time frame: at 12 months
According to z-score
6 secondary outcomes
Evaluation of efficacy, analysis of 12- month deaths
Time frame: at 6 and 12 months
Evaluation of efficacy, analysis of - Quality-of-life questionnaires
Time frame: at 6 and 12 months
Evaluation of efficacy, analysis of Functional capacity
Time frame: at 6 and 12 months
Evaluation of efficacy, analysis of Percentage of hospitalizations for HF
Time frame: at 6 and 12 months
Evaluation of efficacy, analysis of left ventricule volume by echocardiography transthoracic
Time frame: at 6 and 12 months
Evaluation of efficacy, Packer score
Time frame: at 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Derived from this study: PubMed 27836874Eschalier R, Ploux S, Pereira B, Clementy N, Da Costa A, Defaye P, Garrigue S, Gourraud JB, Gras D, Guy-Moyat B, Leclercq C, Mondoly P, Bordachar P. Assessment of cardiac resynchronisation therapy in patients with wide QRS and non-specific intraventricular conduction delay: rationale and design of the multicentre randomised NICD-CRT study. BMJ Open. 2016 Nov 11;6(11):e012383. doi: 10.1136/bmjopen-2016-012383.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Romain ESCHALIER principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT implantation in people with Heart Failure, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 20 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 28 Jun 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gérald GOUBY (04 73 75 49 62, ggouby@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of 2 clinical endpoints combined (12 months all-cause deaths and percentage of hospitalizations for HF at 12 months) combined using an average z-score. (time frame: at 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 NCT02454439, 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 28 Jun 2021.