100 Participants Needed

LVAD Conditioning for Heart Failure

JK
Overseen ByJohn Kirk
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: STAVROS G DRAKOS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate the potential recovery of heart function in end-stage heart failure patients supported with a Left Ventricular Assist Device (LVAD) through applying a myocardial conditioning protocol. During myocardial conditioning, LVAD speed is reduced gradually in order to increase the work load of the heart. Multiple previous studies have shown that interventions like this may improve heart function and give patients the opportunity for a better quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment LVAD Conditioning for Heart Failure?

Research shows that using a Left Ventricular Assist Device (LVAD) can improve quality of life and long-term survival for patients with severe heart failure. Some patients even experience heart recovery, allowing for potential weaning off the device.12345

Is LVAD Conditioning generally safe for humans?

Research shows that while left ventricular assist devices (LVADs) can improve survival, they are associated with risks such as strokes and other adverse events. These risks are important to consider when evaluating the safety of LVADs in humans.678910

How is LVAD Conditioning treatment different from other heart failure treatments?

LVAD Conditioning is unique because it involves using a mechanical device to support the heart's function in patients with severe heart failure, providing an alternative to heart transplantation or as a bridge to it. Unlike medications, this treatment physically assists the heart in pumping blood, which can be crucial for patients with advanced heart failure.511121314

Research Team

SD

Stavros Drakos, MD

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for heart failure patients who are getting an LVAD implant as a temporary step before a transplant. They must be part of another study (IRB 30622) and able to give consent. People who don't understand English or have been hospitalized due to complications during earlier treatment phases cannot join.

Inclusion Criteria

Enrolled in the Effects of Mechanical Unloading on Myocardial Function and Structure study (IRB 30622)
I am diagnosed with heart failure and will get an LVAD before a transplant.

Exclusion Criteria

I or my representative do not understand spoken English.
Neither the subject nor the subject's representative is willing to provide written consent for participation
I was not hospitalized due to side effects during the initial treatment phase.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Optimum Unloading Phase

Heart failure patients undergo an optimum unloading phase with LVAD support to stabilize their condition before controlled reloading

Varies

Controlled Cardiac Reloading

Participants undergo controlled cardiac reloading through LVAD speed adjustment reductions to promote myocardial recovery

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including heart tissue analysis and echocardiography

12 months

Treatment Details

Interventions

  • LVAD Conditioning
Trial OverviewThe study tests if adjusting the speed of the LVAD can help improve heart function by gradually increasing the heart's workload. This method, known as myocardial conditioning, could potentially enhance quality of life for those with severe heart failure.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Controlled Cardiac ReloadingExperimental Treatment1 Intervention
Heart failure patients with recent LVAD implantation after an optimum unloading phase, will undergo controlled cardiac reloading through LVAD speed adjustment reductions in a controlled reloading phase

LVAD Conditioning is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Left Ventricular Assist Device for:
  • Advanced heart failure
  • Bridge to transplant
  • Destination therapy
🇺🇸
Approved in United States as Left Ventricular Assist Device for:
  • Advanced heart failure
  • Bridge to transplant
  • Destination therapy
🇨🇦
Approved in Canada as Left Ventricular Assist Device for:
  • Advanced heart failure
  • Bridge to transplant
  • Destination therapy
🇯🇵
Approved in Japan as Left Ventricular Assist Device for:
  • Advanced heart failure
  • Bridge to transplant
  • Destination therapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

STAVROS G DRAKOS

Lead Sponsor

Trials
3
Recruited
600+

American Heart Association

Collaborator

Trials
352
Recruited
6,196,000+

Findings from Research

Patients on the heart transplant waiting list supported by contemporary continuous-flow LVADs have significantly lower mortality rates compared to those without LVADs, particularly in urgency statuses 1A and 1B, indicating improved outcomes with modern devices.
However, complications related to LVADs can lead to a 28% rate of status upgrades, which significantly increase mortality risk, especially in patients requiring biventricular assist devices or temporary VADs, highlighting the importance of managing these complications.
Morbidity and mortality in heart transplant candidates supported with mechanical circulatory support: is reappraisal of the current United network for organ sharing thoracic organ allocation policy justified?Wever-Pinzon, O., Drakos, SG., Kfoury, AG., et al.[2021]
In a study of 3,836 patients with continuous-flow LVADs, pre-operative health status was found to have a limited association with post-surgery outcomes, indicating that initial health conditions may not predict mortality or rehospitalization after LVAD implantation.
However, health status measured three months after surgery, particularly using the Kansas City Cardiomyopathy Questionnaire (KCCQ), was significantly associated with increased mortality risk, suggesting that ongoing health assessments post-LVAD could be crucial for patient management.
Association of global and disease-specific health status with outcomes following continuous-flow left ventricular assist device implantation.Flint, KM., Spertus, JA., Tang, F., et al.[2018]
Left ventricular assist devices (LVADs) have significantly improved the quality of life and long-term survival rates for patients with heart failure, addressing a critical health issue.
The latest LVAD models are designed to be smaller and more efficient, leading to fewer adverse events and better durability, but careful patient selection is essential for achieving the best outcomes.
Challenges and Future Directions in Left Ventricular Assist Device Therapy.Kanwar, MK., Bailey, S., Murali, S.[2018]

References

Morbidity and mortality in heart transplant candidates supported with mechanical circulatory support: is reappraisal of the current United network for organ sharing thoracic organ allocation policy justified? [2021]
Association of global and disease-specific health status with outcomes following continuous-flow left ventricular assist device implantation. [2018]
Challenges and Future Directions in Left Ventricular Assist Device Therapy. [2018]
A detailed explantation assessment protocol for patients with left ventricular assist devices with myocardial recovery. [2022]
Left ventricular assist device implantation and clinical outcomes in the Netherlands. [2023]
Cerebrovascular Events in Patients With Centrifugal-Flow Left Ventricular Assist Devices: Propensity Score-Matched Analysis From the Intermacs Registry. [2021]
Cerebrovascular Events in Patients With Centrifugal-Flow Left Ventricular Assist Devices: Propensity Score-Matched Analysis From the Intermacs Registry. [2021]
Adverse events in contemporary continuous-flow left ventricular assist devices: A multi-institutional comparison shows significant differences. [2015]
Three-year follow-up after less-invasive left ventricular assist device exchange to HeartMate 3™. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Quantifying the impact from stroke during support with continuous flow ventricular assist devices: An STS INTERMACS analysis. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Clinical considerations for the evaluation of patients with left ventricular assist devices. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Outcomes Associated With Left Ventricular Assist Devices Among Recipients With and Without End-stage Renal Disease. [2019]
Septuagenarian population has similar survival and outcomes to younger patients after left ventricular assist device implantation. [2020]
14.United Statespubmed.ncbi.nlm.nih.gov
PCI in Patients Supported With CF-LVADs: Indications, Safety, and Outcomes. [2017]