Effects of Multipoint Pacing CRT-D on Neurohormonal Activation.

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT02139891
• Lead Sponsor: University of Rome Tor Vergata

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-25
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes in blood concentrations of N-terminal pro-B type natriuretic peptide (NT pro-BNP)	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

Name	Time	Method
Echocardiographic changes	Baseline. 3-Month. 6-Month.	Left ventricular end diastolic volume. Left ventricular end systolic volume. Left ventricular ejection fraction. Mitral regurgitation severity.
Flow-mediated vasodilation	Baseline. 3-month. 6-month	Differences in FMD between groups
Changes in Quality of Life (QOL), as assessed by the Minnesota Living With Heart Failure Questionnaire	Baseline. 3-Month. 6-Month.
Occurrence of atrial and ventricular arrhythmias (amount and duration [h/day]).	3-Month. 6-Month.
Packer's clinical composite score	Baseline. 3-month. 6-month.	Distribution of "improved", "unchanged" and "worsened" patients as defined per Packer's clinical composite score
Appropriate device interventions (anti-tachycardia pacing or shock)	3-Month. 6-Month.
6-Minute-Walking-Distance	Baseline. 3 Month. 6 Month.	The distance walked by subjects during a 6 minutes walking test
Changes in Neurohormonal Activation	Baseline. 3-Month. 6-Month.	Renin, Aldosteron, Norepinephrine, Endothelin-1.
Heart Failure Hospitalizations	3-Month. 6-Month.
New York Heart Association (NYHA) Class changes	Baseline. 3-Month. 6-Month.
Phrenic Nerve Complication Free Rate	3-Month. 6-Month.

Trial Locations

Locations (2)

Istituto Clinico St. Ambrogio; 🇮🇹 Milano, Italy

Policlinico Tor Vergata; 🇮🇹 Rome, Italy