Heart FailureNCT02402816
MPP Narrow QRS:Pilot Study on Multipoint Pacing in Patients With QRS Beetwen 100 and 130 Msec
A study testing MultiPoint Pacing ON and Implantable cardioverter-defibrillator (ICD) in people with Heart Failure, run by Humanitas Hospital, Italy at 6 sites in Italy.
Trial summary
The purpose of this study is to assess the impact of the Multi Point Pacing (MPP) feature in the treatment of patients with QRS beetwen 100 and 130 msec in patients candidate to ICD implant. 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?
- MultiPoint Pacing ON and Implantable cardioverter-defibrillator (ICD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesItaly
- Study dates
- May 2016to May 2018
- 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 with EF < 35% on OPT at least 3 months and candidate to ICD
- QRS duration: 100-130 ms
- Patients willing and able to comply with study requirements
- Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form
- Successful quadripolar LV lead implant (only for Treatment Group)
Who cannot join
- Myocardial Infarction, unstable angina within 40 days prior the enrollment
- Patients with no left ventricular contractile reserve after low dose dobutamine stress echocardiography test
- Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
- Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
- Primary valvular disease
- Unable to comply with the follow up schedule
Show all 13Show fewer
- Less than 18 years of age
- Pregnant or are planning to become pregnant during the duration of the investigation
- Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
- Undergone a cardiac transplantation
- Life expectancy < 12 months
- Patients with permanent Atrial fibrillation
- Patients with Nyha 1
Trial locations and contacts
6 sites in 1 country.
Maurizio Gasparini, MD contact
6 sites in 1 country
Italy6 sites
Ospedale Maggiore di Crema
Crema
Maurizio Landolina, MD
A.O. Niguarda Ca' Granda
Milan, 20162
Maurizio Lunati, MD
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Roberto Rordorf, MD
Ospedale S.Maria della Misericordia
Rovigo
Francesco Zanon, MD
Humanitas Research Hospital
Rozzano
Maurizio Gasparini, MD
Ospedale Santa Maria della Misericordia
Udine
Alessandro Proclemer, MD
About this study
Official title: MPP Narrow QRS:Pilot Study on Multipoint Pacing in Patients With Narrow QRS
The purpose of this study is to assess the impact of the Multi Point Pacing (MPP) feature in the treatment of patients with QRS beetwen 100 and 130 msec in patients candidate to ICD implant.
- Conditions
- Heart Failure
- Being tested
- MultiPoint Pacing ON, Implantable cardioverter-defibrillator (ICD)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultiPoint Pacing ONDevice
MultiPoint Pacing ON
Implantable cardioverter-defibrillator (ICD)Device
Implantable cardioverter-defibrillator (ICD)
| Study group | Role | What they receive |
|---|---|---|
| MPP ON | Experimental | Patients will be randomized to the MPP-ON Arm vs Standard ICD Receives: Device: MultiPoint Pacing ON |
| Standard ICD | Active comparator | Patients will be randomized to the MPP-ON Arm vs Standard ICD Receives: Device: Implantable cardioverter-defibrillator (ICD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 6 and 12 months
Measured: up to 12 Months
Secondary outcomes (4)
Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 24 months
Measured: 24-Months
Percentage of responder patients in term of increase of EF > 5 points % at 12 months Follow-Up
Measured: 12-Months
Percentage of responder patients in term of increase of EF > 5 points % at 24 months Follow-Up
Measured: 24-Months
Percentage of responder patients in term of BNP < 400 pg/ml at 12 months
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 posted30 Mar 2015 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2018 (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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanitas Hospital, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Maurizio Gasparini, Humanitas Hospital, Italy
- Investigators
- Maurizio Gasparini, MD, Principal investigator, Humanitas Research Hospital-Rozzano-Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402816
- Sponsor's protocol ID
- 1.0
- Status last verified
- Feb 2016
- First submitted
- 25 Mar 2015
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gasparini M, Galimberti P, Bragato R, Ghio S, Raineri C, Landolina M, Chieffo E, Lunati M, Mulargia E, Proclemer A, Facchin D, Rordorf R, Vicentini A, Marcantoni L, Zanon F, Klersy C. Multipoint Pacing versus conventional ICD in Patients with a Narrow QRS complex (MPP Narrow QRS trial): study protocol for a pilot randomized controlled trial. Trials. 2016 Dec 3;17(1):572. doi: 10.1186/s13063-016-1698-1.
PubMed 27927248
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MPP Narrow QRS:Pilot Study on Multipoint Pacing in Patients With Narrow QRS
- ClinicalTrials.gov ID
- NCT02402816
- Acronym / sponsor ID
- 1.0
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Humanitas Hospital, ItalyUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 30 Mar 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 purpose of this study is to assess the impact of the Multi Point Pacing (MPP) feature in the treatment of patients with QRS beetwen 100 and 130 msec in patients candidate to ICD implant.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPP ON | Experimental | Device: MultiPoint Pacing ONPatients will be randomized to the MPP-ON Arm vs Standard ICD |
| Standard ICD | Active comparator | Device: Implantable cardioverter-defibrillator (ICD)Patients will be randomized to the MPP-ON Arm vs Standard ICD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with EF < 35% on OPT at least 3 months and candidate to ICD
- QRS duration: 100-130 ms
- Patients willing and able to comply with study requirements
- Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form
- Successful quadripolar LV lead implant (only for Treatment Group)
Key exclusion criteria (13 listed)
- Myocardial Infarction, unstable angina within 40 days prior the enrollment
- Patients with no left ventricular contractile reserve after low dose dobutamine stress echocardiography test
- Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
- Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
- Primary valvular disease
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 |
|---|---|---|
| MultiPoint Pacing ONMultiPoint Pacing ON | Device | MPP ON |
| Implantable cardioverter-defibrillator (ICD)Implantable cardioverter-defibrillator (ICD) | Device | Standard ICD |
Primary outcome
Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 6 and 12 months
Time frame: up to 12 Months
4 secondary outcomes
Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 24 months
Time frame: 24-Months
Percentage of responder patients in term of increase of EF > 5 points % at 12 months Follow-Up
Time frame: 12-Months
Percentage of responder patients in term of increase of EF > 5 points % at 24 months Follow-Up
Time frame: 24-Months
Percentage of responder patients in term of BNP < 400 pg/ml at 12 months
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Derived from this study: PubMed 27927248Gasparini M, Galimberti P, Bragato R, Ghio S, Raineri C, Landolina M, Chieffo E, Lunati M, Mulargia E, Proclemer A, Facchin D, Rordorf R, Vicentini A, Marcantoni L, Zanon F, Klersy C. Multipoint Pacing versus conventional ICD in Patients with a Narrow QRS complex (MPP Narrow QRS trial): study protocol for a pilot randomized controlled trial. Trials. 2016 Dec 3;17(1):572. doi: 10.1186/s13063-016-1698-1.
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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.
Maurizio Gasparini, MD contact
Maurizio Gasparini, MD principal investigator
Humanitas Research Hospital-Rozzano-Italy
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MultiPoint Pacing ON and Implantable cardioverter-defibrillator (ICD) in people with Heart Failure, run by Humanitas Hospital, Italy at 6 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 5 inclusion and 13 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 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maurizio Gasparini, MD (maurizio.gasparini@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 6 and 12 months (time frame: up to 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 NCT02402816, 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 19 Feb 2016.