Impact of Cardiac Resynchronization Therapy on Right Ventricular Function in Left Ventricular Assist Device Patients (CRT-LVAD)

Cardiac Resynchronization Therapy in Patients With Left Ventricular Assist Devices

Left Ventricular Assist Devices (LVAD) are mechanical heart pumps that are increasingly being implanted in patients with severe heart failure which have failed medical therapy. In patients with LVADs, right ventricular failure, which is not supported by the LVAD pump, is a major problem that affects quality-of-life and survival. Cardiac Resynchronization Therapy (CRT) aims to restore the synchronized contraction of the heart and has proven to be beneficial for improving ejection fraction of both right and left ventricle as well as quality of life in selected heart failure patients. The role of CRT in patients with LVADs is unknown. We hypothesize that CRT can exert a beneficial impact on right ventricular function in LVAD patients and improve their quality-of-life.

The specific questions that this study aims to answer are:

1. What are the effects of CRT on the function of the non-supported right ventricle in patients with an implanted LVAD?
2. Can the effects of CRT on cardiac function positively impact quality-of-life and exercise capacity in LVAD recipients?

In this study patients with a previously implanted CRT device, who later receives an LVAD, will be randomly assigned to have the CRT turned off (CRT-off) or on (CRT-on). The patients will be followed for an 8-week period, and then switched over to the opposite CRT status. The total participation in this study will last for 16 ± 1 weeks, and will involve 3 clinic visits of approximately 3 hour duration (initial visit, 8 week visit, and 16 week final visit), plus 2 quick checks of the pacemaker/defibrillator in-between the visits. Heart function will be assessed with comprehensive echocardiographic studies during the CRT "on" and CRT "off" periods. Quality-of-life and exercise capacity will be assessed with a standardized questionnaire and a 6-Minute Walk Test.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure
• Intervention / Treatment: Device: Cardiac Resynchronization Therapy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Heart failure patients with previously implanted Bi-Ventricular pacemaker / defibrillator, and continuous flow LVAD (Heart Mate II® or HeartWare®)
• The LVAD must be implanted between 8 weeks and 18 months prior to enrollment
• Patients should be at least 3 weeks post discharge from the LVAD implant hospitalization

Exclusion Criteria:

• Severe decompensated right ventricular failure defined as requiring any of the following:

  • Hospitalization for heart failure within last 30 days
  • Need for inotropic infusion for > 48h within the last 14 days
  • Increase of > 100% diuretic dose within last 14 days
• Severe aortic regurgitation documented by echocardiography or cardiac catheterization
• Stage IV or greater kidney disease (GFR < 30 mL/min/1.73 m2)
• Active infection (not including controlled chronic driveline infection on suppressive antibiotic therapy)
• Biventricular pacing < 90 % of time due to uncontrolled arrhythmias
• LVAD malfunction
• Inability to follow study protocol
• Non-functional LV lead (i.e. high capture threshold that cannot be corrected with programming changes)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CRT-On; Cardiac Resynchronization Therapy enabled on ICD/Pacemaker device	Device: Cardiac Resynchronization Therapy; The cardiac resynchronization therapy of the ICD/Pacemaker device of the patients enrolled in the study will be programed under a standardized protocol and enabled or disabled in a crossover fashion during the study.
Sham Comparator: CRT-Off; Cardiac Resynchronization Therapy disabled on ICD/Pacemaker device	Device: Cardiac Resynchronization Therapy; The cardiac resynchronization therapy of the ICD/Pacemaker device of the patients enrolled in the study will be programed under a standardized protocol and enabled or disabled in a crossover fashion during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right ventricular function	The primary cardiac performance endpoint is global longitudinal right ventricular (RV) function assessed by myocardial strain analysis using Speckle Tracking Echocardiography (STE). Other traditional echocardiographic RV function indexes will also be evaluated.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	Will be assessed by 6-Minute Walk Test	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality-of-Life	Assessed by standardized self administered Minnesota Living with Heart Failure Questionnaire (MLHFQ)	8 weeks

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: Rakesh Gopinathannair, MD, MA, FHRS, University of Louisville; Principal Investigator: Martin A Espinosa Ginic, MD, University of Louisville

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 18, 2014
• First Submitted That Met QC Criteria: June 18, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Estimate): January 5, 2017
• Last Update Submitted That Met QC Criteria: January 3, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Ventricular Assist Device, Cardiac Resynchronization Therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 14.0338