Effects of Multipoint Pacing CRT-D on Neurohormonal Activation.
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cardiac Resynchronization Therapy with MultiPoint Pacing
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Cardiac Resynchronization Therapy, non responders, MultiPoint Pacing (MPP)
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Istituto Clinico St. Ambrogio
- Policlinico Tor Vergata
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MultiPoint Pacing "On"
MultiPoint Pacing "Off"
Arm Description
Patients will be randomized to the MPP-ON Arm vs MPP-OFF in in crossover fashion with 3 months in each period.
Patients will be randomized to the MPP-OFF arm vs MPP-ON in crossover fashion with 3 months in each period.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in Neurohormonal Activation
Renin, Aldosteron, Norepinephrine, Endothelin-1.
Heart Failure Hospitalizations
New York Heart Association (NYHA) Class changes
Changes in Quality of Life (QOL), as assessed by the Minnesota Living With Heart Failure Questionnaire
Echocardiographic changes
Left ventricular end diastolic volume. Left ventricular end systolic volume. Left ventricular ejection fraction. Mitral regurgitation severity.
Appropriate device interventions (anti-tachycardia pacing or shock)
Phrenic Nerve Complication Free Rate
Occurrence of atrial and ventricular arrhythmias (amount and duration [h/day]).
Flow-mediated vasodilation
Differences in FMD between groups
Packer's clinical composite score
Distribution of "improved", "unchanged" and "worsened" patients as defined per Packer's clinical composite score
6-Minute-Walking-Distance
The distance walked by subjects during a 6 minutes walking test
Full Information
NCT ID
NCT02139891
First Posted
May 12, 2014
Last Updated
September 25, 2017
Sponsor
University of Rome Tor Vergata
1. Study Identification
Unique Protocol Identification Number
NCT02139891
Brief Title
Effects of Multipoint Pacing CRT-D on Neurohormonal Activation.
Official Title
Randomized, Crossover Study of the Effects of MultiPoint Left Ventricular Pacing on Neurohormonal Activation.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rome Tor Vergata
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiac Resynchronization Therapy, non responders, MultiPoint Pacing (MPP)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MultiPoint Pacing "On"
Arm Type
Experimental
Arm Description
Patients will be randomized to the MPP-ON Arm vs MPP-OFF in in crossover fashion with 3 months in each period.
Arm Title
MultiPoint Pacing "Off"
Arm Type
Active Comparator
Arm Description
Patients will be randomized to the MPP-OFF arm vs MPP-ON in crossover fashion with 3 months in each period.
Intervention Type
Device
Intervention Name(s)
Cardiac Resynchronization Therapy with MultiPoint Pacing
Primary Outcome Measure Information:
Title
Changes in blood concentrations of N-terminal pro-B type natriuretic peptide (NT pro-BNP)
Description
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.
Time Frame
Baseline. 3-Month. 6-Month.
Secondary Outcome Measure Information:
Title
Changes in Neurohormonal Activation
Description
Renin, Aldosteron, Norepinephrine, Endothelin-1.
Time Frame
Baseline. 3-Month. 6-Month.
Title
Heart Failure Hospitalizations
Time Frame
3-Month. 6-Month.
Title
New York Heart Association (NYHA) Class changes
Time Frame
Baseline. 3-Month. 6-Month.
Title
Changes in Quality of Life (QOL), as assessed by the Minnesota Living With Heart Failure Questionnaire
Time Frame
Baseline. 3-Month. 6-Month.
Title
Echocardiographic changes
Description
Left ventricular end diastolic volume. Left ventricular end systolic volume. Left ventricular ejection fraction. Mitral regurgitation severity.
Time Frame
Baseline. 3-Month. 6-Month.
Title
Appropriate device interventions (anti-tachycardia pacing or shock)
Time Frame
3-Month. 6-Month.
Title
Phrenic Nerve Complication Free Rate
Time Frame
3-Month. 6-Month.
Title
Occurrence of atrial and ventricular arrhythmias (amount and duration [h/day]).
Time Frame
3-Month. 6-Month.
Title
Flow-mediated vasodilation
Description
Differences in FMD between groups
Time Frame
Baseline. 3-month. 6-month
Title
Packer's clinical composite score
Description
Distribution of "improved", "unchanged" and "worsened" patients as defined per Packer's clinical composite score
Time Frame
Baseline. 3-month. 6-month.
Title
6-Minute-Walking-Distance
Description
The distance walked by subjects during a 6 minutes walking test
Time Frame
Baseline. 3 Month. 6 Month.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni B Forleo, MD, PhD
Organizational Affiliation
University of Rome Tor Vergata
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Clinico St. Ambrogio
City
Milano
ZIP/Postal Code
20149
Country
Italy
Facility Name
Policlinico Tor Vergata
City
Rome
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
24291411
Citation
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.
Results Reference
background
PubMed Identifier
24626999
Citation
Rinaldi 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.
Results Reference
background
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Effects of Multipoint Pacing CRT-D on Neurohormonal Activation.
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