LVAD Conditioning for Cardiac Recovery

NCT03238690 | Recruiting DMC FDA Device

• 1 other identifier: IRB_00095106
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

LVAD; Cardiac Recovery

Outcome Measures

Primary Outcomes (1)

• Change in Left Ventricular Ejection Fraction (LVEF)

  LVEF is measured by echocardiography. The average change in LVEF from baseline to 12 months or transplant in the study participant arm will be compared to results from an historical control group.

  Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant

Secondary Outcomes (16)

• Change in Left Ventricular End Diastolic Diameter (LVEDD)

  Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant

• Change in Left Ventricular End Systolic Diameter (LVESD)

  Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant

• Change in Left Ventricular End Diastolic Volume (LVEDV)

  Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant

• Change in Left Ventricular End Systolic Volume (LVESV)

  Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant

• Change in heart tissue Glucose 1-phosphate levels

  Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months)

Study Arms (1)

Controlled Cardiac Reloading

EXPERIMENTAL

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

Device: Controlled Cardiac Reloading through LVAD Speed Adjustment

Interventions

Controlled Cardiac Reloading through LVAD Speed Adjustment DEVICE

LVAD speed is reduced at a fixed rate according to the particular LVAD device model implanted. LVAD speed reduction adjustments will be performed at visits occurring every 2 - 3 weeks, up to a total of 8 visits. Reduction of LVAD speed will continue until the soonest of: minimum operating setting as recommended in the LVAD Operator's manual is reached; the minimum setting tolerated by the subject is reached; the subject completes 8 visits; or until the subject receives a heart transplant.

Controlled Cardiac Reloading

Eligibility Criteria

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

You may qualify if:

• Diagnosed with heart failure undergoing LVAD implantation as a bridge to transplant
• Enrolled in the Effects of Mechanical Unloading on Myocardial Function and Structure study (IRB 30622)

You may not qualify if:

• Neither the subject nor the subject's representative is willing to provide written consent for participation
• Subjects with adverse events leading to hospitalization during the optimum unloading phase are excluded from participation in the controlled reloading phase

Sponsors & Collaborators

• STAVROS G DRAKOS: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (3)

• George RS, Sabharwal NK, Webb C, Yacoub MH, Bowles CT, Hedger M, Khaghani A, Birks EJ. Echocardiographic assessment of flow across continuous-flow ventricular assist devices at low speeds. J Heart Lung Transplant. 2010 Nov;29(11):1245-52. doi: 10.1016/j.healun.2010.05.032. Epub 2010 Aug 5.

  PMID: 20688540 BACKGROUND

• Healy AH, Koliopoulou A, Drakos SG, McKellar SH, Stehlik J, Selzman CH. Patient-controlled conditioning for left ventricular assist device-induced myocardial recovery. Ann Thorac Surg. 2015 May;99(5):1794-6. doi: 10.1016/j.athoracsur.2014.07.058.

  PMID: 25952209 BACKGROUND

• Frazier OH, Baldwin AC, Demirozu ZT, Segura AM, Hernandez R, Taegtmeyer H, Mallidi H, Cohn WE. Ventricular reconditioning and pump explantation in patients supported by continuous-flow left ventricular assist devices. J Heart Lung Transplant. 2015 Jun;34(6):766-72. doi: 10.1016/j.healun.2014.09.015. Epub 2014 Sep 28.

  PMID: 25447571 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Stavros Drakos, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Kirk

CONTACT

801-585-2944; john.kirk@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 3, 2017
• Study Start: June 23, 2017
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)