Heart Diseases, Left Ventricular Dysfunction
Conditions
Brief summary
The primary reason the investigators are doing this study are to understand how the right side of the heart functions in heart failure patients with left ventricular assist devices (LVADs, or mechanical hearts). Second, the investigators are interested in understanding how different pacemaker settings influence function of the heart at rest and activity.
Detailed description
Healthy individuals, as well as patients with advanced heart failure supported by LVADs, completed invasive hemodynamic analysis at rest and with exercise to characterize right-sided heart function at rest and with exercise during invasive cardiopulmonary exercise testing on upright cycle ergometry.
Interventions
None listed
Sponsors
University of Colorado, Denver
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
15 patients with advanced heart failure (HF) who have already undergone implantation of a continuous-flow left ventricular assist device (CF-LVAD) implantation. Inclusion criteria: 1. Have already received CF-LVADs and are clinically stable, 2. Ambulatory outpatients and are fully recovered (at least 3 months) from LVAD implantation;
Exclusion criteria
1. Individuals with clinical right ventricular (RV) failure under resting conditions, defined as moderate-severely reduced RV systolic function on echocardiography, or 2. Clinical evidence of RV failure (elevated jugular venous pressures, 3 or 4+ \[significant\] peripheral edema); 3. Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease); and 10 healthy individuals will serve as a control group to define normal RV function during exercise. Inclusion criteria: 1\) Persons without a past medical history of cardiovascular disease or related disease such as: 1. hypertension, 2. diabetes, 3. peripheral vascular disease, 4. arrhythmias, f. are not taking any cardiac-related medications (e.g. antihypertensive medications).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Vo2 | 20 minutes | peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing |
| Cardiac Output | 20 minutes | cardiac output measured during invasive cardiopulmonary exercise testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minute Ventilation | 20 minutes | Minute ventilation during cardiopulmonary exercise testing |
| Tau | 20 minutes | unit of measure of diastolic function during exercise |
| Blood Pressure | 20 minutes | mean arterial pressure during exercise |
| EES/EA | 20 minutes | ventricular arterial coupling during exercise |
| Stroke Work | 20 minutes | stroke work during exercise |
| Respiratory Exchange Ratio | 20 minutes | Respiratory exchange ratio derived from indirect calorimetry |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Control Healthy controls free of heart disease and not on any medications. Age 18+ years | 9 |
| LVAD Group Heart failure patients supported by LVAD | 13 |
| Total | 22 |
Baseline characteristics
| Characteristic | LVAD Group | Total | Healthy Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 18 Participants | 9 Participants |
| Age, Continuous | 61 years STANDARD_DEVIATION 9 | 52 years STANDARD_DEVIATION 14 | 42 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 22 Participants | 9 Participants |
| Region of Enrollment United States | 13 Participants | 22 Participants | 9 Participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 12 Participants | 18 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 13 |
| other Total, other adverse events | 0 / 9 | 0 / 13 |
| serious Total, serious adverse events | 0 / 9 | 0 / 13 |
Outcome results
Primary
Cardiac Output
cardiac output measured during invasive cardiopulmonary exercise testing.
Time frame: 20 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Control | Cardiac Output | 18.4 L/min | Standard Deviation 7.3 |
| LVAD Group w/Pacemaker | Cardiac Output | 9.1 L/min | Standard Deviation 3.3 |
Primary
Peak Vo2
peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing
Time frame: 20 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Control | Peak Vo2 | 33 ml/kg/min | Standard Deviation 10.4 |
| LVAD Group w/Pacemaker | Peak Vo2 | 12.5 ml/kg/min | Standard Deviation 3.2 |
Secondary
Blood Pressure
mean arterial pressure during exercise
Time frame: 20 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Control | Blood Pressure | 119 mmHg | Standard Deviation 7 |
| LVAD Group w/Pacemaker | Blood Pressure | 91 mmHg | Standard Deviation 10 |
Secondary
EES/EA
ventricular arterial coupling during exercise
Time frame: 20 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Control | EES/EA | 1.6 ratio | Standard Deviation 0.8 |
| LVAD Group w/Pacemaker | EES/EA | 1.40 ratio | Standard Deviation 0.34 |
Secondary
Minute Ventilation
Minute ventilation during cardiopulmonary exercise testing
Time frame: 20 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Control | Minute Ventilation | 102 L/min | Standard Deviation 40 |
| LVAD Group w/Pacemaker | Minute Ventilation | 56 L/min | Standard Deviation 19 |
Secondary
Respiratory Exchange Ratio
Respiratory exchange ratio derived from indirect calorimetry
Time frame: 20 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Control | Respiratory Exchange Ratio | 1.08 ratio | Standard Deviation 0.08 |
| LVAD Group w/Pacemaker | Respiratory Exchange Ratio | 0.03 ratio | Standard Deviation 0.08 |
Secondary
Stroke Work
stroke work during exercise
Time frame: 20 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Control | Stroke Work | 4999 mmHg*mL | Standard Deviation 2342 |
| LVAD Group w/Pacemaker | Stroke Work | 2455 mmHg*mL | Standard Deviation 783 |
Secondary
Tau
unit of measure of diastolic function during exercise
Time frame: 20 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Control | Tau | 25 msec | Standard Deviation 6 |
| LVAD Group w/Pacemaker | Tau | 54 msec | Standard Deviation 49 |