Influence of Right Ventricular Function on Changes in Exercise Capacity After LVAD

This is an exploratory project with the purpose to describe the responses of the right ventricle (RV) and gas exchange during exercise in patients scheduled to undergo left ventricular assist device (LVAD) implant. Such information might be used to predict the likelihood of RV failure after LVAD implant. Additionally, although patients that undergo LVAD implantation have improved quality of life and survival, their exercise tolerance (although improved) remains markedly reduced compared to healthy subjects. No studies have used cardiopulmonary stress testing and echocardiography to assess cardiac function and gas exchange with LVAD implantation to determine potential factors responsible for their limited function. The aims of this study are as follows:

1. To assess the impact of right ventricle (RV) dysfunction on functional capacity before and after left ventricular assist device (LVAD) implant
2. To determine if the combined use of preoperative clinical, CPX and echo data can assist in predicting who will meet target improvements in functional capacity after LVAD implant.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure With Reduced Ejection Fraction; Left Ventricular Assist Device

Detailed Description

Prior to the 21st century, the management of patients with end stage heart failure with a reduced ejection fraction (HFrEF) was very limited. For optimal candidates only, heart transplantation may be an option. However, donor hearts are a limited resource in which supply is greatly less than demand. For those patients that are either not candidates for transplantation or never received a compatible heart offer, medical therapy was the only option. Unfortunately patients with end stage HFrEF on medical therapy have a 1 year mortality of greater than 50%. Over the past several decades development of durable left ventricular assist devices (LVAD) has given many end stage heart failure patients another therapeutic option. Compared to optimal medical therapy, these devices have demonstrated significant superiority with improved quality of life and survival benefit (Rose et al. NEJM, 2001). Since their development these devices have undergone many modifications to improve outcomes and reduce complications. However, unfortunately since these devices only support a failing left ventricle, their success is dependent on adequate right ventricular function. Therefore, when considering LVAD implantation, it is imperative that thorough RV assessment takes place in order to avoid implanting these devices in patients in which the RV will subsequently fail. Several studies have investigated clinical, laboratory, hemodynamic and resting echo parameters to help determine which patients have right ventricles that may or may not fail after LVAD implantation. Unfortunately no such risk models or parameters are both greatly sensitive and specific. Consequently, anywhere from 10-40% of LVAD implantations are complicated by RV failure (Lampert and Teuteberg. J of Heart and Lung Transplant, 2015). No studies to date have assessed the right ventricle during exercise testing to determine if exercise-induced parameters could help better predict which patients could undergo LVAD implantation not complicated by RV failure.

This is an exploratory project with the purpose to describe the responses of the right ventricle (RV) and gas exchange during exercise in patients scheduled to undergo left ventricular assist device (LVAD) implant. Such information might be used to predict the likelihood of RV failure after LVAD implant. Additionally, although patients that undergo LVAD implantation have improved quality of life and survival, their exercise tolerance (although improved) remains markedly reduced compared to healthy subjects. No studies have used cardiopulmonary stress testing and echocardiography to assess cardiac function and gas exchange with LVAD implantation to determine potential factors responsible for their limited function. The aims of this study are as follows:

1. To assess the impact of right ventricle (RV) dysfunction on functional capacity before and after left ventricular assist device (LVAD) implant
2. To determine if the combined use of preoperative clinical, CPX and echo data can assist in predicting who will meet target improvements in functional capacity after LVAD implant.

The purposes of this pilot study, as described above, would add to the literature by providing initial insights into RV characteristics during rest and stress (exercise) both before and after LVAD implantation. This information may help guide future studies designed to better predict which patients would or would not develop RV failure after LVAD implantation.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Population that will be studied will be adult end stage heart failure patients (Stage D according to American College of Cardiology/American Heart Association staging system) that have reduced ejections fraction of <25%. These patients must be eligible for LVAD implantation.

Description

Inclusion Criteria:

• Stage D heart failure with reduced ejection fraction
• EF <25%
• Eligible for implantation of left ventricular assist device (LVAD) as either destination therapy (DT) or bridge to transplantation (BTT)
• Body mass index (BMI) less than or equal to 40

Exclusion Criteria:

• Prior LVAD implantation
• Pt that underwent cardiopulmonary stress test as LVAD workup, however, did not receive LVAD for any reason

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right ventricular function with exercise after LVAD implant	Echocardiography derived right ventricular function assessment during cardiopulmonary stress testing will be compared before and after LVAD implant	8-12 weeks after LVAD implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right ventricular function and quality of life after LVAD implant	Correlation of right ventricular function with exercise and quality of life both before and after LVAD implant	8-12 weeks after LVAD implant
Correlation of right ventricular function and functional capacity after LVAD implantation	Correlation of right ventricular function before and after LVAD implant assessed by cardiopulmonary stress testing and 6 minute walk test.	8-12 weeks after LVAD implant

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: LVAD; Right ventricular dysfunction; Cardiopulmonary stress test; Stage D heart failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Sciamanna01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No