Heart FailureNCT02139891
Effects of Multipoint Pacing CRT-D on Neurohormonal Activation.
A study testing Cardiac Resynchronization Therapy with MultiPoint Pacing in people with Heart Failure, run by University of Rome Tor Vergata at 2 sites in Italy.
Trial summary
This study will examine the additional clinical benefit conferred by multipoint pacing (MPP) compared to standard CRT over a period of 3 months. Patients will be randomized to MPP ON vs. OFF and followed for a total of 6 months. This includes two crossover periods for each pacing modality (MPP on vs. off). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac Resynchronization Therapy with MultiPoint Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- May 2014to Mar 2017
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients implanted with a St. Jude Medical CRT-D system with MPP capability
- Patients must be willing and able to sign an appropriate informed consent form and comply with study requirements
- NT pro-BNP levels equal to or greater than 500 pg/ml.
Who cannot join
- History of stroke, PCI, myocardial infarction or unstable angina pectoris within the last 3 months.
- Atrial fibrillation with noncontrolled heart rate
- Need for intravenous inotropic support for CHF
- Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
- Undergone a cardiac transplantation
- Currently participating in any other clinical investigation
Show all 9Show fewer
- Life expectancy < 12 months due to a disorder other than CHF
- Inability to comply with the follow-up procedures
- Patients who are or may potentially be pregnant
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Istituto Clinico St. Ambrogio
Milan, 20149
Policlinico Tor Vergata
Rome
About this study
Official title: Randomized, Crossover Study of the Effects of MultiPoint Left Ventricular Pacing on Neurohormonal Activation.
This study will examine the additional clinical benefit conferred by multipoint pacing (MPP) compared to standard CRT over a period of 3 months. Patients will be randomized to MPP ON vs. OFF and followed for a total of 6 months. This includes two crossover periods for each pacing modality (MPP on vs. off).
Read the detailed description
Cardiac resynchronization therapy (CRT) is limited by a high proportion of non-responders. Pacing activation from multiple separated left ventricular (LV) sites might improve the depolarization pattern, thereby promoting more physiological activation. To explore the effect of MPP on cardiac neuro-hormonal activity, the investigators will enroll approximately 30 patients who already underwent CRT-D implantation with a quadripolar LV lead connected to a device capable of MPP.
This pilot study will have a randomized, double-blind, cross-over design. Patients will be randomized to receive either standard biventricular pacing (MPP-OFF) or MPP (MPP-ON) within 4-6 months following the implantation procedure. Each subject will crossover to the other study group after three months. The baseline evaluation should be acquired prior to the device being programmed to the randomized setting. Repeat evaluations will be performed at the end of each 3 month crossover period.
Participation in this study will last approximately 6 months. Patients, as well as investigators other than the EP physicians, will be blinded to the pacing mode.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy with MultiPoint Pacing
- Keywords
- Cardiac Resynchronization Therapy, non responders, MultiPoint Pacing (MPP)
- 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 Therapy with MultiPoint PacingDevice
| Study group | Role | What they receive |
|---|---|---|
| MultiPoint Pacing "On" | Experimental | Patients will be randomized to the MPP-ON Arm vs MPP-OFF in in crossover fashion with 3 months in each period. Receives: Device: Cardiac Resynchronization Therapy with MultiPoint Pacing |
| MultiPoint Pacing "Off" | Active comparator | Patients will be randomized to the MPP-OFF arm vs MPP-ON in crossover fashion with 3 months in each period. Receives: Device: Cardiac Resynchronization Therapy with MultiPoint Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood concentrations of N-terminal pro-B type natriuretic peptide (NT pro-BNP)
Changes in plasma NT pro-BNP using the difference from baseline to three months as compared to the difference from three to six months within a patient.
Measured: Baseline. 3-Month. 6-Month.
Secondary outcomes (11)
Changes in Neurohormonal Activation
Renin, Aldosteron, Norepinephrine, Endothelin-1.
Measured: Baseline. 3-Month. 6-Month.
Heart Failure Hospitalizations
Measured: 3-Month. 6-Month.
New York Heart Association (NYHA) Class changes
Measured: Baseline. 3-Month. 6-Month.
Changes in Quality of Life (QOL), as assessed by the Minnesota Living With Heart Failure Questionnaire
Measured: Baseline. 3-Month. 6-Month.
Echocardiographic changes
Left ventricular end diastolic volume. Left ventricular end systolic volume. Left ventricular ejection fraction. Mitral regurgitation severity.
Measured: Baseline. 3-Month. 6-Month.
Appropriate device interventions (anti-tachycardia pacing or shock)
Measured: 3-Month. 6-Month.
Phrenic Nerve Complication Free Rate
Measured: 3-Month. 6-Month.
Occurrence of atrial and ventricular arrhythmias (amount and duration [h/day]).
Measured: 3-Month. 6-Month.
Flow-mediated vasodilation
Differences in FMD between groups
Measured: Baseline. 3-month. 6-month
Packer's clinical composite score
Distribution of "improved", "unchanged" and "worsened" patients as defined per Packer's clinical composite score
Measured: Baseline. 3-month. 6-month.
6-Minute-Walking-Distance
The distance walked by subjects during a 6 minutes walking test
Measured: Baseline. 3 Month. 6 Month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni B Forleo, University of Rome Tor Vergata
- Investigators
- Giovanni B Forleo, MD, PhD, Principal investigator, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139891
- Sponsor's protocol ID
- PTVCARDIO022014
- Status last verified
- Sep 2017
- First submitted
- 12 May 2014
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Pappone C, Calovic Z, Vicedomini G, Cuko A, McSpadden LC, Ryu K, Romano E, Saviano M, Baldi M, Pappone A, Ciaccio C, Giannelli L, Ionescu B, Petretta A, Vitale R, Fundaliotis A, Tavazzi L, Santinelli V. Multipoint left ventricular pacing improves acute hemodynamic response assessed with pressure-volume loops in cardiac resynchronization therapy patients. Heart Rhythm. 2014 Mar;11(3):394-401. doi: 10.1016/j.hrthm.2013.11.023. Epub 2013 Nov 28.
PubMed 24291411Rinaldi CA, Leclercq C, Kranig W, Kacet S, Betts T, Bordachar P, Gutleben KJ, Shetty A, Donal E, Keel A, Ryu K, Farazi TG, Simon M, Naqvi TZ. Improvement in acute contractility and hemodynamics with multipoint pacing via a left ventricular quadripolar pacing lead. J Interv Card Electrophysiol. 2014 Jun;40(1):75-80. doi: 10.1007/s10840-014-9891-1. Epub 2014 Mar 14.
PubMed 24626999
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Crossover Study of the Effects of MultiPoint Left Ventricular Pacing on Neurohormonal Activation.
- ClinicalTrials.gov ID
- NCT02139891
- Acronym / sponsor ID
- PTVCARDIO022014
- Conditions
- Heart Failure
- Keywords
- Cardiac Resynchronization Therapy, non responders, MultiPoint Pacing (MPP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 15 May 2014 (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.
This study will examine the additional clinical benefit conferred by multipoint pacing (MPP) compared to standard CRT over a period of 3 months. Patients will be randomized to MPP ON vs. OFF and followed for a total of 6 months. This includes two crossover periods for each pacing modality (MPP on vs. off).
Detailed description
Cardiac resynchronization therapy (CRT) is limited by a high proportion of non-responders. Pacing activation from multiple separated left ventricular (LV) sites might improve the depolarization pattern, thereby promoting more physiological activation. To explore the effect of MPP on cardiac neuro-hormonal activity, the investigators will enroll approximately 30 patients who already underwent CRT-D implantation with a quadripolar LV lead connected to a device capable of MPP.
This pilot study will have a randomized, double-blind, cross-over design. Patients will be randomized to receive either standard biventricular pacing (MPP-OFF) or MPP (MPP-ON) within 4-6 months following the implantation procedure. Each subject will crossover to the other study group after three months. The baseline evaluation should be acquired prior to the device being programmed to the randomized setting. Repeat evaluations will be performed at the end of each 3 month crossover period.
Participation in this study will last approximately 6 months. Patients, as well as investigators other than the EP physicians, will be blinded to the pacing mode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MultiPoint Pacing "On" | Experimental | Device: Cardiac Resynchronization Therapy with MultiPoint PacingPatients will be randomized to the MPP-ON Arm vs MPP-OFF in in crossover fashion with 3 months in each period. |
| MultiPoint Pacing "Off" | Active comparator | Device: Cardiac Resynchronization Therapy with MultiPoint PacingPatients will be randomized to the MPP-OFF arm vs MPP-ON in crossover fashion with 3 months in each period. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients implanted with a St. Jude Medical CRT-D system with MPP capability
- Patients must be willing and able to sign an appropriate informed consent form and comply with study requirements
- NT pro-BNP levels equal to or greater than 500 pg/ml.
Key exclusion criteria (9 listed)
- History of stroke, PCI, myocardial infarction or unstable angina pectoris within the last 3 months.
- Atrial fibrillation with noncontrolled heart rate
- Need for intravenous inotropic support for CHF
- Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
- Undergone a cardiac transplantation
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 Therapy with MultiPoint Pacing | Device | MultiPoint Pacing "Off", MultiPoint Pacing "On" |
Primary outcome
Changes in blood concentrations of N-terminal pro-B type natriuretic peptide (NT pro-BNP)
Time frame: Baseline. 3-Month. 6-Month.
Changes in plasma NT pro-BNP using the difference from baseline to three months as compared to the difference from three to six months within a patient.
11 secondary outcomes
Changes in Neurohormonal Activation
Time frame: Baseline. 3-Month. 6-Month.
Heart Failure Hospitalizations
Time frame: 3-Month. 6-Month.
New York Heart Association (NYHA) Class changes
Time frame: Baseline. 3-Month. 6-Month.
Changes in Quality of Life (QOL), as assessed by the Minnesota Living With Heart Failure Questionnaire
Time frame: Baseline. 3-Month. 6-Month.
Echocardiographic changes
Time frame: Baseline. 3-Month. 6-Month.
Appropriate device interventions (anti-tachycardia pacing or shock)
Time frame: 3-Month. 6-Month.
Phrenic Nerve Complication Free Rate
Time frame: 3-Month. 6-Month.
Occurrence of atrial and ventricular arrhythmias (amount and duration [h/day]).
Time frame: 3-Month. 6-Month.
Flow-mediated vasodilation
Time frame: Baseline. 3-month. 6-month
Packer's clinical composite score
Time frame: Baseline. 3-month. 6-month.
6-Minute-Walking-Distance
Time frame: Baseline. 3 Month. 6 Month.
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 26 Sep 2017.
- Background: PubMed 24291411Pappone C, Calovic Z, Vicedomini G, Cuko A, McSpadden LC, Ryu K, Romano E, Saviano M, Baldi M, Pappone A, Ciaccio C, Giannelli L, Ionescu B, Petretta A, Vitale R, Fundaliotis A, Tavazzi L, Santinelli V. Multipoint left ventricular pacing improves acute hemodynamic response assessed with pressure-volume loops in cardiac resynchronization therapy patients. Heart Rhythm. 2014 Mar;11(3):394-401. doi: 10.1016/j.hrthm.2013.11.023. Epub 2013 Nov 28.
- Background: PubMed 24626999Rinaldi CA, Leclercq C, Kranig W, Kacet S, Betts T, Bordachar P, Gutleben KJ, Shetty A, Donal E, Keel A, Ryu K, Farazi TG, Simon M, Naqvi TZ. Improvement in acute contractility and hemodynamics with multipoint pacing via a left ventricular quadripolar pacing lead. J Interv Card Electrophysiol. 2014 Jun;40(1):75-80. doi: 10.1007/s10840-014-9891-1. Epub 2014 Mar 14.
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.
Giovanni B Forleo, MD, PhD principal investigator
University of Rome Tor Vergata
2 sites 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 with MultiPoint Pacing in people with Heart Failure, run by University of Rome Tor Vergata at 2 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 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 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Changes in blood concentrations of N-terminal pro-B type natriuretic peptide (NT pro-BNP) (time frame: Baseline. 3-Month. 6-Month.). 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 NCT02139891, which also lists 2 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 26 Sep 2017.