Heart Failure
Conditions
Keywords
Left Ventricular Assist Device (LVAD), Cardiac resynchronization therapy (CRT)
Brief summary
The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist devices (LVAD). Only patients are blinded. This is a small-scale study from which future larger scale randomized controls can be performed. The primary endpoint will be the effect of BiV and RV pacing setting on the 6-minute walk test.
Detailed description
Heart failure patients with reduced left ventricular systolic function and worsening clinical status are frequently treated with mechanical devices. Cardiac resynchronization therapy (CRT) and left ventricular assist devices (LVAD) are mainstays of advanced heart failure treatment and have independently been demonstrated to decrease mortality. However, minimal research documents the utility of these two modalities in unison. There have been recent investigations comparing Biventricular (BiV) versus right ventricular (RV) pacing suggesting better exercise performance and decreased left ventricular (LV) volumes with RV pacing. This discovery contrasts with prior meta-analysis that reports no difference between LVAD patients with and without CRT including mortality and hospitalizations. Investigators aim to compare BiV pacing and RV pacing in LVAD patients with CRT on patient's exercise tolerance and frequency of tachyarrhythmias. Additionally, research is required to form a conclusion on the role of CRT in LVAD patients.
Interventions
DEVICEBiventricular Pacing
The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.
DEVICERight Ventricular Pacing
The CRT device will be reprogrammed for right ventricular contractions.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with both an LVAD and CRT device with functional leads * Age 18 years and older * Ability to walk * Ability to sign consent
Exclusion criteria
* Patients with permanent atrial fibrillation * Patients who are pacemaker dependent * Patients with sustained ventricular tachycardia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute Walk Test Performance | Baseline visit; Three-month visit | The distance walked over 6 minutes was measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-3L Quality of Life Score | Baseline visit | Quality of Life was measured using the EQ-5D-3L questionnaire. The EQ-5D-3L asks participants to rate the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated as either no problems (score of 1), some problems (score of 2), or extreme problems (score of 3). Higher scores indicating a poorer overall quality of life in these dimensions. Scores on the five dimensions are summarized to create an index score. The EQ-5D-3L index score is a numerical value that summarizes a person's health state on a scale from -0.594 to 1: * 1: Full health * 0 or less: Equivalent to being dead or worse than dead The questionnaire was only completed at the baseline visit for the single participant on study. |
| Serum NT-PRO-BNP | Baseline visit; Three-month visit | Serum levels of N-terminal pro-brain natriuretic peptide (NT-PRO-BNP) were measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biventricular Pacing Followed by Right Ventricular Pacing Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to BiV-first will have their CRT device reprogrammed to BiV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to RV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality.
Biventricular Pacing: The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.
Right Ventricular Pacing: The CRT device will be reprogrammed for right ventricular contractions. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Biventricular Pacing Followed by Right Ventricular Pacing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | NA years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
6 Minute Walk Test Performance
The distance walked over 6 minutes was measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated.
Time frame: Baseline visit; Three-month visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biventricular Pacing Followed by Right Ventricular Pacing | 6 Minute Walk Test Performance | Baseline visit | 350 meters |
| Biventricular Pacing Followed by Right Ventricular Pacing | 6 Minute Walk Test Performance | Three month visit | 375 meters |
Secondary
EQ-5D-3L Quality of Life Score
Quality of Life was measured using the EQ-5D-3L questionnaire. The EQ-5D-3L asks participants to rate the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated as either no problems (score of 1), some problems (score of 2), or extreme problems (score of 3). Higher scores indicating a poorer overall quality of life in these dimensions. Scores on the five dimensions are summarized to create an index score. The EQ-5D-3L index score is a numerical value that summarizes a person's health state on a scale from -0.594 to 1: * 1: Full health * 0 or less: Equivalent to being dead or worse than dead The questionnaire was only completed at the baseline visit for the single participant on study.
Time frame: Baseline visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biventricular Pacing Followed by Right Ventricular Pacing | EQ-5D-3L Quality of Life Score | -0.293 score on a scale |
Secondary
Serum NT-PRO-BNP
Serum levels of N-terminal pro-brain natriuretic peptide (NT-PRO-BNP) were measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated.
Time frame: Baseline visit; Three-month visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biventricular Pacing Followed by Right Ventricular Pacing | Serum NT-PRO-BNP | Three-month visit | 515 pg/mL |
| Biventricular Pacing Followed by Right Ventricular Pacing | Serum NT-PRO-BNP | Baseline visit | 470 pg/mL |