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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University of Louisville
Sponsor:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT02169076
First received: June 18, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Heart Failure
Device: Cardiac Resynchronization Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cardiac Resynchronization Therapy in Patients With Left Ventricular Assist Devices

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Right ventricular function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Functional capacity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Will be assessed by 6-Minute Walk Test


Other Outcome Measures:
  • Quality-of-Life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Assessed by standardized self administered Minnesota Living with Heart Failure Questionnaire (MLHFQ)


Estimated Enrollment: 30
Study Start Date: September 2014
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02169076

Contacts
Contact: Martin A Espinosa Ginic, MD (502) 852 7959 maespi01@louisville.edu
Contact: Deirdre J Higdon, ARNP (502) 852 1839 djwrig01@louisville.edu

Locations
United States, Kentucky
Jewish Hospital Not yet recruiting
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Rakesh Gopinathannair, MD, MA, FHRS University of Louisville
Principal Investigator: Martin A Espinosa Ginic, MD University of Louisville
  More Information

No publications provided

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT02169076     History of Changes
Other Study ID Numbers: 14.0338
Study First Received: June 18, 2014
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
Ventricular Assist Device, Cardiac Resynchronization Therapy

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014