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

NCT05916612 | Withdrawn

• 1 other identifier: Sciamanna01
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.To assess the impact of right ventricle (RV) dysfunction on functional capacity before and after left ventricular assist device (LVAD) implant
2. 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.

Conditions

Heart Failure With Reduced Ejection Fraction; Left Ventricular Assist Device

Keywords

LVAD; Cardiopulmonary stress test; Right ventricular dysfunction; Stage D heart failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Right ventricular function and quality of life after LVAD implant

  8-12 weeks after LVAD implant

• Correlation of right ventricular function and functional capacity after LVAD implantation

  8-12 weeks after LVAD implant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Henry Ford Health System: lead

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: June 23, 2023
• Study Start: July 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: September 25, 2023

Record last verified: 2023-09