Effects of Multipoint Pacing CRT-D on Neurohormonal Activation.

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139891
• Other study ID #: PTVCARDIO022014
• Status: Completed
• Phase: N/A
• First received: May 12, 2014
• Last updated: September 25, 2017
• Start date: May 2014
• Est. completion date: March 2017

Study information

• Verified date: September 2017
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Cardiac Resynchronization Therapy with MultiPoint Pacing

Locations

Country	Name	City	State
Italy	Istituto Clinico St. Ambrogio	Milano
Italy	Policlinico Tor Vergata	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Pappone C, Calovic Ž, 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. — View 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. — View Citation

Outcome

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