RAMP-IT-UP

Principal Investigator: Stavros Drakos
Keywords: LVAD , Hemodynamics , Echocardiography , Mechanical Circulatory Support , Cardiology , Cardiothoracic Surgery Department: Cardiovascular Medicine
IRB Number: 00095829 Co Investigator:  
Specialty: Cardiology, Cardiology, Cardiology, Cardiothoracic Surgery, Cardiothoracic Surgery, Cardiothoracic Surgery, Cardiology, Cardiology
Sub Specialties: Interventional Cardiology, Heart Failure, Cardiac Mechanical Support, Heart Failure, Echocardiography, Heart Transplant
Recruitment Status: Not yet recruiting

Contact Information

Ashley Elmer
ashley.elmer@hsc.utah.edu
801-585-6775

Brief Summary

The goals are:

  1. Demonstrate the feasibility of performing hemodynamic ramp studies and confirm key findings of our single-center experience in other MCS programs.
  2. Obtain sufficient prospective data to provide preliminary support for the hypothesis that adjustments of device RPM and medical therapies based on results of hemodynamic ramp tests have an impact on patient quality of life, exercise tolerance and outcomes.
  3. Provide sufficient data to estimate sample size of a fully powered study to prove clinical benefits of hemodynamic ramp test.
  4. Validate noninvasive approaches for performing hemodynamic ramp tests.  Key noninvasive parameters will include HVAD waveforms and 2-D echo-Doppler measures of tricuspid regurgitation jet, pulmonary venous flow.

Hypothesis

HVAD (a left ventricular assist device, manufactured by HeartWare, Inc.) speed and medical therapy adjustments utilizing data from Hemodynamic-Echo Ramp Tests in a pilot study will show trends to improve objective indexes of quality of life, exercise tolerance and reduced cardiac adverse events.

Study Design

Multicenter, prospective randomized study with two arms:

  1. Treatment Group:  Speed adjustment using Hemodynamics-Echo Ramp Test
  2. Control Group:  Speed adjustment based on standard echocardiographic measures according to ISHLT guidelines

Study Endpoints

Since this is designed as a pilot study, it is not powered to provide statistically significant results for any one parameter.  Rather, the goal is to identify clinical parameters most likely to be impacted by hemodynamic-echo ramp tests and to determine sample sizes for a fully powered study.  The endpoints of interest that will be evaluated in the current study include:

  1. 6 minute hall walk test
  2. Composite end-point of heart failure readmissions, readmission for arrhythmias, stroke and mortality
  3. Quality of life parameters of KCCQ and NYHA Class

Other endpoints that will be evaluated include:

  1. Development or worsening of aortic insufficiency
  2. GI bleeding events
  3. Device thrombosis
  4. All neurological complications

Two parameters that will be measured as sub-studies performed at University of Chicago will include:

  1. 3D echocardiographic measures of LV and RV size and geometry during RPM Ramp Tests
  2. Comparison of changes in Peak VO2 between groups

 

Inclusion Criteria

Inclusion Criteria

  1. Patient older than 18 years
  2. Newly implanted HVAD
  3. HVAD support anticipated for at least 6 months
  4. Patient is ambulatory and discharged from hospital without inotropes
  5. Patient is between 1 and 3 months post implant
  6. Patient has not had a right heart catheterization since discharged from HVAD implantation hospitalization

Exclusion Criteria

Exclusion Criteria

  1. The current HVAD is a replacement device
  2. Patients currently has RV failure requiring home inotropes
  3. Inability to performed right heart cath
  4. Inadequate echocardiographic windows
  5. Significant serious adverse events (SAEs) prior to hospital discharge that is not resolved (e.g., stroke, renal failure requiring dialysis).  SAEs that have resolved (such as right heart failure, infection, bleeding) are not exclusions.
  6. HVAD as BTT or BTD with anticipation for explantation in less than 6 months