Effects of Multipoint Pacing CRT-D on Neurohormonal Activation.

September 25, 2017 updated by: Giovanni B Forleo, University of Rome Tor Vergata

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20149
        • Istituto Clinico St. Ambrogio
      • Rome, Italy
        • Policlinico Tor Vergata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline. 3-Month. 6-Month.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Neurohormonal Activation
Time Frame: Baseline. 3-Month. 6-Month.
Renin, Aldosteron, Norepinephrine, Endothelin-1.
Baseline. 3-Month. 6-Month.
Heart Failure Hospitalizations
Time Frame: 3-Month. 6-Month.
3-Month. 6-Month.
New York Heart Association (NYHA) Class changes
Time Frame: Baseline. 3-Month. 6-Month.
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.
Baseline. 3-Month. 6-Month.
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.
Baseline. 3-Month. 6-Month.
Appropriate device interventions (anti-tachycardia pacing or shock)
Time Frame: 3-Month. 6-Month.
3-Month. 6-Month.
Phrenic Nerve Complication Free Rate
Time Frame: 3-Month. 6-Month.
3-Month. 6-Month.
Occurrence of atrial and ventricular arrhythmias (amount and duration [h/day]).
Time Frame: 3-Month. 6-Month.
3-Month. 6-Month.
Flow-mediated vasodilation
Time Frame: Baseline. 3-month. 6-month
Differences in FMD between groups
Baseline. 3-month. 6-month
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
Baseline. 3-month. 6-month.
6-Minute-Walking-Distance
Time Frame: Baseline. 3 Month. 6 Month.
The distance walked by subjects during a 6 minutes walking test
Baseline. 3 Month. 6 Month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Investigators

  • Principal Investigator: Giovanni B Forleo, MD, PhD, University of Rome Tor Vergata

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 13, 2014

First Posted (Estimate)

May 15, 2014

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

September 25, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTVCARDIO022014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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