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Completed

NCT Number: NCT02139891

Effects of Multipoint Pacing CRT-D 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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Clinico St. Ambrogio, Milan, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Resynchronization Therapy with MultiPoint Pacing

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

Randomized, Crossover Study of the Effects of MultiPoint Left Ventricular Pacing on Neurohormonal Activation.

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 15, 2014
Registry last updated
Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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