Heart FailureCRT-MORENCT01573091
Cardiac Resynchronization Therapy Modular Registry
An observational study of Heart Failure, run by Giuseppe Ricciardi at 12 sites in Italy.
Trial summary
The purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy. 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?
- Cardiac Resynchronization Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 12 sitesItaly
- Study dates
- Dec 2011to Dec 2015
- Phase
- Observational
- 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
Study population: All patients eligible for CRT device implanted according to current guidelines
Who may be able to join
- Chronic symptomatic HF despite stable, optimal drug therapy
- Indication for a cardiac resynchronisation device with or without defibrillator backup according to current guidelines
- Patients implanted with cardiac resynchronization device
Who cannot join
- Patients participating in other studies that clearly impact the clinical practice of the center
- Patients who are unable to provide informed consent
- Patients who can not perform follow-up in the center
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites
Ospedale Degli Infermi
Biella, Biella, 61679
Cardiovascular Department, Electrophysiology Unit, Istituto Ospedaliero Fondazione Poliambulanza
Brescia, 25124
Department of Heart and Vessels, University of Florence
Florence, 50134
Department of Cardiology and Coronary Care Unit, Azienda Ospedaliera S. Antonio Abate
Gallarate, 21013
Department of Cardio, Thoracic and Vascular, Azienda Ospedaliera Carlo Poma
Mantua, 46100
San Giacomo e Cristoforo
Massa, Massa, 54100
Department of Heart, Electrophysiology, Clinica Mediterranea
Naples, 80122
Azienda Ospedale dei Colli - Monaldi
Naples, 80131
Policlinico Federico II
Naples
Azienda Ospedaliera di Padova
Padova, Padova, 61353
Azienda Ospedaliera San Salvatore
Pesaro, Pesaro, 61998
Department of Cardiology, Ospedale Civile "Misericordia e Dolce"
Prato, 59100
About this study
The purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.
Read the detailed description
Heart failure is a complex clinical syndrome characterized by a high prevalence and incidence in populations at greatest risk and, therefore, with a significant social and economic impact. Randomized clinical trials, meta-analyzes, observational studies and controlled trials clearly demonstrated that the neuro-hormonal therapy is highly effective in reducing mortality, hospitalization and improving quality of life. In recent years the electrical therapy is playing an increasingly important role in the treatment of patients with chronic heart failure. Such importance is mainly due to the possibility of preventing sudden cardiac death by implanting an ICD and to correct the deleterious effects of electrical dyssynchrony and / or left ventricular mechanics by CRT. The CRT has proven an effective tool in reducing mortality, reducing symptoms and improving quality of life in patients already receiving optimal medical therapy. Despite the undoubted benefits that the electrical treatment has added to conventional medical therapy, a high percentage of patients does not benefit in terms of clinical and echocardiographic. The identification of non-responders to CRT is crucial in order not to submit the patients to an unnecessary and costly device whose electrical therapy proves to be ineffective. The reason for lack of response is still unclear but factors such as lead placement, device-settings and the degree of dyssynchrony before implant seems to be important. The purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy
- Keywords
- Cardiac resynchronization therapy, Heart failure
- Medical subject headings
- 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
Any commercially available Cardiac Resynchronization Therapy devices with or without defibrillation backup (CRT-D/CRT-P) can be used upon discretion of the investigator according to current guidelines
| Study group | Role | What they receive |
|---|---|---|
| Heart failure patients | Patients with a CRT device according to current guidelines Receives: Procedure: Cardiac Resynchronization Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Improvement in functional class status by at least one NYHA Class or remain in functional class II
Measured: 24 months
Echocardiographic response of absolute increase of ≥5% in LVEF
Patients at follow-up to 6-12 months show an increase of the absolute value of the LVEF than 5%
Measured: 24 months
Echocardiographic response of ≥15% reduction in LVESV
Patients at follow-up to 6-12 months show a systolic volume (LVESV) reduction greater than 15%
Measured: 24 months
Secondary outcomes (3)
LV lead/RV lead geometric distance
To investigate the correlation of LV lead/RV lead geometric distance (as measured by fluoroscopy) and reverse remodeling in cardiac resynchronization therapy (as measured by echocardiography as defined in primary outcome measure) at 12 months. The relation with LVESVi change between baseline and 12 months will be analyzed.
Measured: 12 months
Change from baseline in R wave in 12-lead ECG at 12 months
To investigate the relationship between the ECG characteristics at baseline and response to cardiac resynchronization therapy (as measured by echocardiography as defined in primary outcome measure) at 12 months. The purpose of this objective is to evaluate the R wave in 12-lead ECG during BIV, RV and LV pacing and change from baseline at 12 months.
Measured: 12 months
Number of ventricular arrhythmias after cardiac resynchronization therapy
To investigate the relationship between LV pacing and the number of ventricular tachycardia/fibrillation and/or appropriate/inappropriate shocks. The number and type of arrhythmia before and after upgrading to CRT device at 24 months will be analyzed
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giuseppe Ricciardi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giuseppe Ricciardi, University of Florence
- Investigators
- Luigi Padeletti, MD, Study chair, Department of Heart and Vessels, University of Florence, Florence, Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573091
- Sponsor's protocol ID
- 2011/0043537
- Acronym
- CRT-MORE
- Status last verified
- Feb 2017
- First submitted
- 2 Apr 2012
- Last updated
- 24 Feb 2017
- Results posted
- No
- Individual data sharing
- No
Publications
Bertaglia E, Reggiani A, Palmisano P, D'Onofrio A, De Simone A, Caico SI, Pecora D, Arena G, Marini M, Ricciardi G, Badolati S, Spotti A, Solimene F, Ferraro A, Migliore F, Botto GL, Malacrida M, Stabile G. The stricter criteria for Class I CRT indication suggested by the 2016 ESC Guidelines reliably exclude patients with a worse prognosis in comparison with the 2013 ESC indication criteria. Int J Cardiol. 2018 Dec 15;273:162-167. doi: 10.1016/j.ijcard.2018.09.027. Epub 2018 Sep 8.
PubMed 30217421Stabile G, Pepi P, Palmisano P, D'Onofrio A, De Simone A, Caico SI, Pecora D, Rapacciuolo A, Arena G, Marini M, Pieragnoli P, Badolati S, Savarese G, Maglia G, Iuliano A, Botto GL, Malacrida M, Bertaglia E. Adherence to 2016 European Society of Cardiology guidelines predicts outcome in a large real-world population of heart failure patients requiring cardiac resynchronization therapy. Heart Rhythm. 2018 Nov;15(11):1675-1682. doi: 10.1016/j.hrthm.2018.04.011. Epub 2018 Apr 14.
PubMed 29665405Stabile G, D'Onofrio A, Pepi P, De Simone A, Santamaria M, Caico SI, Rapacciuolo A, Padeletti L, Pecora D, Giovannini T, Arena G, Spotti A, Iuliano A, Bertaglia E, Malacrida M, Botto GL. Interlead anatomic and electrical distance predict outcome in CRT patients. Heart Rhythm. 2015 Nov;12(11):2221-9. doi: 10.1016/j.hrthm.2015.05.020. Epub 2015 May 19.
PubMed 26001509
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronization Therapy Modular Registry
- ClinicalTrials.gov ID
- NCT01573091
- Acronym / sponsor ID
- CRT-MORE / 2011/0043537
- Conditions
- Heart Failure
- Keywords
- Cardiac resynchronization therapy, Heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Giuseppe RicciardiUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 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.
The purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.
Detailed description
Heart failure is a complex clinical syndrome characterized by a high prevalence and incidence in populations at greatest risk and, therefore, with a significant social and economic impact. Randomized clinical trials, meta-analyzes, observational studies and controlled trials clearly demonstrated that the neuro-hormonal therapy is highly effective in reducing mortality, hospitalization and improving quality of life. In recent years the electrical therapy is playing an increasingly important role in the treatment of patients with chronic heart failure. Such importance is mainly due to the possibility of preventing sudden cardiac death by implanting an ICD and to correct the deleterious effects of electrical dyssynchrony and / or left ventricular mechanics by CRT. The CRT has proven an effective tool in reducing mortality, reducing symptoms and improving quality of life in patients already receiving optimal medical therapy. Despite the undoubted benefits that the electrical treatment has added to conventional medical therapy, a high percentage of patients does not benefit in terms of clinical and echocardiographic. The identification of non-responders to CRT is crucial in order not to submit the patients to an unnecessary and costly device whose electrical therapy proves to be ineffective. The reason for lack of response is still unclear but factors such as lead placement, device-settings and the degree of dyssynchrony before implant seems to be important. The purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure patients | – | Procedure: Cardiac Resynchronization TherapyPatients with a CRT device according to current guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients eligible for CRT device implanted according to current guidelines
Key inclusion criteria (3 listed)
- Chronic symptomatic HF despite stable, optimal drug therapy
- Indication for a cardiac resynchronisation device with or without defibrillator backup according to current guidelines
- Patients implanted with cardiac resynchronization device
Key exclusion criteria (3 listed)
- Patients participating in other studies that clearly impact the clinical practice of the center
- Patients who are unable to provide informed consent
- Patients who can not perform follow-up in the center
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 TherapyAny commercially available Cardiac Resynchronization Therapy devices with or without defibrillation backup (CRT-D/CRT-P) can be used upon discretion of the investigator according to current guidelines | Procedure or surgery | Heart failure patients |
Primary outcome
Clinical response
Time frame: 24 months
Improvement in functional class status by at least one NYHA Class or remain in functional class II
Echocardiographic response of absolute increase of ≥5% in LVEF
Time frame: 24 months
Patients at follow-up to 6-12 months show an increase of the absolute value of the LVEF than 5%
Echocardiographic response of ≥15% reduction in LVESV
Time frame: 24 months
Patients at follow-up to 6-12 months show a systolic volume (LVESV) reduction greater than 15%
3 secondary outcomes
LV lead/RV lead geometric distance
Time frame: 12 months
Change from baseline in R wave in 12-lead ECG at 12 months
Time frame: 12 months
Number of ventricular arrhythmias after cardiac resynchronization therapy
Time frame: 24 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 24 Feb 2017.
- Derived from this study: PubMed 30217421Bertaglia E, Reggiani A, Palmisano P, D'Onofrio A, De Simone A, Caico SI, Pecora D, Arena G, Marini M, Ricciardi G, Badolati S, Spotti A, Solimene F, Ferraro A, Migliore F, Botto GL, Malacrida M, Stabile G. The stricter criteria for Class I CRT indication suggested by the 2016 ESC Guidelines reliably exclude patients with a worse prognosis in comparison with the 2013 ESC indication criteria. Int J Cardiol. 2018 Dec 15;273:162-167. doi: 10.1016/j.ijcard.2018.09.027. Epub 2018 Sep 8.
- Derived from this study: PubMed 29665405Stabile G, Pepi P, Palmisano P, D'Onofrio A, De Simone A, Caico SI, Pecora D, Rapacciuolo A, Arena G, Marini M, Pieragnoli P, Badolati S, Savarese G, Maglia G, Iuliano A, Botto GL, Malacrida M, Bertaglia E. Adherence to 2016 European Society of Cardiology guidelines predicts outcome in a large real-world population of heart failure patients requiring cardiac resynchronization therapy. Heart Rhythm. 2018 Nov;15(11):1675-1682. doi: 10.1016/j.hrthm.2018.04.011. Epub 2018 Apr 14.
- Derived from this study: PubMed 26001509Stabile G, D'Onofrio A, Pepi P, De Simone A, Santamaria M, Caico SI, Rapacciuolo A, Padeletti L, Pecora D, Giovannini T, Arena G, Spotti A, Iuliano A, Bertaglia E, Malacrida M, Botto GL. Interlead anatomic and electrical distance predict outcome in CRT patients. Heart Rhythm. 2015 Nov;12(11):2221-9. doi: 10.1016/j.hrthm.2015.05.020. Epub 2015 May 19.
- Individual participant dataSharing planned: No
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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.
Luigi Padeletti, MD study chair
Department of Heart and Vessels, University of Florence, Florence, Italy.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Giuseppe Ricciardi at 12 sites 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 3 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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Clinical response (time frame: 24 months). The study lists 3 primary outcomes in all. 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 NCT01573091, which also lists 3 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 24 Feb 2017.