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Heart Failure With Reduced Ejection FractionNCT05916612

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

An observational study of Heart Failure With Reduced Ejection Fraction and Left Ventricular Assist Device, run by Henry Ford Health System.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2018to 1 Feb 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

About this study

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.
Read the 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.

Keywords
LVAD, Cardiopulmonary stress test, Right ventricular dysfunction, Stage D heart failure
Medical subject headings
Ventricular Dysfunction, Right

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 8-12 weeks after LVAD implant

Secondary outcomes (2)
  1. 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

    Measured: 8-12 weeks after LVAD implant

  2. 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.

    Measured: 8-12 weeks after LVAD implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2023
  2. Study startJul 2018 (estimated)
  3. Primary completion1 Feb 2019
  4. Study completion1 Feb 2019

Why it stopped: Decision not to move forward with study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05916612
Sponsor's protocol ID
Sciamanna01
Status last verified
Sep 2023
First submitted
16 Aug 2017
Last updated
25 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure With Reduced Ejection Fraction and Left Ventricular Assist Device, run by Henry Ford Health System.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Right ventricular function with exercise after LVAD implant (time frame: 8-12 weeks after LVAD implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.

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