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Effects of Multipoint Pacing CRT-D on Neurohormonal Activation.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139891
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Giovanni B Forleo, University of Rome Tor Vergata

Study Description
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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).

Condition or disease Intervention/treatment Phase
Heart Failure Device: Cardiac Resynchronization Therapy with MultiPoint Pacing Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Crossover Study of the Effects of MultiPoint Left Ventricular Pacing on Neurohormonal Activation.
Study Start Date : May 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: MultiPoint Pacing "On"
Patients will be randomized to the MPP-ON Arm vs MPP-OFF in in crossover fashion with 3 months in each period.
 Device: Cardiac Resynchronization Therapy with MultiPoint Pacing
Active Comparator: MultiPoint Pacing "Off"
Patients will be randomized to the MPP-OFF arm vs MPP-ON in crossover fashion with 3 months in each period.
 Device: Cardiac Resynchronization Therapy with MultiPoint Pacing


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes in Neurohormonal Activation [ Time Frame: Baseline. 3-Month. 6-Month. ]
    Renin, Aldosteron, Norepinephrine, Endothelin-1.

  2. Heart Failure Hospitalizations [ Time Frame: 3-Month. 6-Month. ]
  3. New York Heart Association (NYHA) Class changes [ Time Frame: Baseline. 3-Month. 6-Month. ]
  4. Changes in Quality of Life (QOL), as assessed by the Minnesota Living With Heart Failure Questionnaire [ Time Frame: Baseline. 3-Month. 6-Month. ]
  5. Echocardiographic changes [ Time Frame: Baseline. 3-Month. 6-Month. ]
    Left ventricular end diastolic volume. Left ventricular end systolic volume. Left ventricular ejection fraction. Mitral regurgitation severity.

  6. Appropriate device interventions (anti-tachycardia pacing or shock) [ Time Frame: 3-Month. 6-Month. ]
  7. Phrenic Nerve Complication Free Rate [ Time Frame: 3-Month. 6-Month. ]
  8. Occurrence of atrial and ventricular arrhythmias (amount and duration [h/day]). [ Time Frame: 3-Month. 6-Month. ]
  9. Flow-mediated vasodilation [ Time Frame: Baseline. 3-month. 6-month ]
    Differences in FMD between groups

  10. Packer's clinical composite score [ Time Frame: Baseline. 3-month. 6-month. ]
    Distribution of "improved", "unchanged" and "worsened" patients as defined per Packer's clinical composite score

  11. 6-Minute-Walking-Distance [ Time Frame: Baseline. 3 Month. 6 Month. ]
    The distance walked by subjects during a 6 minutes walking test


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139891


Locations
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Italy
Istituto Clinico St. Ambrogio
Milano, Italy, 20149
Policlinico Tor Vergata
Rome, Italy
Sponsors and Collaborators
University of Rome Tor Vergata
Investigators
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Principal Investigator: Giovanni B Forleo, MD, PhD University of Rome Tor Vergata
More Information
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Publications:

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Responsible Party: Giovanni B Forleo, MD, PhD., University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT02139891    
Other Study ID Numbers: PTVCARDIO022014
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Keywords provided by Giovanni B Forleo, University of Rome Tor Vergata:
Cardiac Resynchronization Therapy
non responders
MultiPoint Pacing (MPP)
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases