Ischemic and Non-ischemic Cardiomyopathy
Conditions
Keywords
ICD, OptiVol-Monitor, Cardiac Compass, Garmin Vivo Smart, Guideline Directed Medical Therapy
Brief summary
This clinical study is designed to show that a multidisciplinary team following a pre-specified standard of care medication decision model based on data from an implanted cardioverter device will increase the rate of change in Guideline Directed Medical Therapy (GDMT) in the intervention group compared to the conventional group in patients with ischemic and non-ischemic cardiomyopathies.
Detailed description
Subjects in this study will be randomized (2:1) to an intervention group whose medical care will be guided by data from a cardiac implantable electronic device (CIED) including information on heart rate, activity, and fluid status derived from the OptiVol monitor versus a conventional management control group. Subjects will followed for 12 months with follow up contact for 6 consecutive months and a chart review at 12 months. The study population will include patients with ischemic and non-ischemic cardiomyopathy who have had an ICD implanted per standard of care guidelines.
Interventions
DEVICEMedtronic ICD with Opti Vol-Monitor
Physiologic and functional data from Cardiac Implantable Electronic Devices (CIEDs), including information on heart rate, activity, and fluid status derived from the OptiVol monitor, together with a concurrent patient engagement strategy through remote interactions, can be used to optimize the medical management of HF patients implanted with an ICD.
Sponsors
Medtronic
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 85 years of age on the date of randomization * ICD implantation per guidelines for primary prevention in patients with ischemic and non-ischemic cardiomyopathy ≥3 calendar months ago. * SMART Phone or tablet with Bluetooth capability with internet access. * No other identifiable reversible cause explaining the left ventricular dysfunction
Exclusion criteria
* CRT implanted * LVEF\>45% in the last echocardiogram or other clinic imaging study performed. * Medtronic device generator and/or device components not implanted * Unstable clinical condition, life threatening arrhythmia * Heart failure hospitalization within the preceding 3 calendar months * Cognitive impairment * Severe renal dysfunction (eGFR \< 30 ml/min/m2) * Serious known concomitant disease with a lift expectancy of \< 12 calendar months * Non-ambulatory NYHA class IV * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of Change in Medical Management With Beta-blockers, Diuretics and Sacubitril/Valsartan (Defined as Initiation, Termination, Switch, or Dosing Adjustment) in the Intervention Group Compared to Usual Care | 6 Months | The rate of change as measured in the number of medications modified during medical management with beta-blockers, diuretics and sacubitril/Valsartan (defined as initiation, termination, switch, or dosing adjustment) in the intervention group compared to usual care will serve as the primary outcome. The (minimum, maximum) values (0,5) and the range (0 - 5) apply to the rate of change of the prespecified medications. The greater the rate of change, the more optimization (better) the intervention is altering medical management to personalize the regimen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Quality of Life Score | 6 month | The Kansas City Cardiomyopathy Questionnaire (KCCQ) was used to measure Quality of Life from index discharge to 6 months after discharge in the GDMT intervention vs. control (CMT) groups. Mean changes in KCCQ score for the overall summary score in which positive changes are associated with better QOL outcome and negative change associated with worsened outcome. The absolute KCCQ score can range from 0-100 with higher score associated with better outcomes. |
Countries
United States
Participant flow
Recruitment details
7 patients were enrolled and randomized to either Conventional Medical Therapy vs. Intervention group
Participants by arm
| Arm | Count |
|---|---|
| ICM Guided Medical Management Group A pre-specified management regimen based on standard clinical practice will be provided to the study team in which medical management including medication dosing (focusing on beta-blockers and diuretics) will be monitored and modified using Cardiac Implantable Electronic Devices (CIED) and OptiVol Monitor data. Based on CIED and patient engagement data, the study team will adjust medications and dosages, and optimize activity/exercise steps.
Medtronic ICD with Opti Vol-Monitor: Physiologic and functional data from Cardiac Implantable Electronic Devices (CIEDs), including information on heart rate, activity, and fluid status derived from the OptiVol monitor, together with a concurrent patient engagement strategy through remote interactions, can be used to optimize the medical management of HF patients implanted with an ICD. | 4 |
| Conventional Management Control Group Non-study physicians will receive CIED/OptiVol data (as in usual care) and its use and the management strategy will be left to his/her discretion. To control for patient contact, patients in the conventional management group will have the same study visits as the interventional group and will include in-person device interrogation, and documentation of any medications changes. | 3 |
| Total | 7 |
Baseline characteristics
| Characteristic | ICM Guided Medical Management Group | Conventional Management Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 13.6 | 65.7 years STANDARD_DEVIATION 4.1 | 64 years STANDARD_DEVIATION 13.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| History of Atrial Fibrillation | 3 Participants | 2 Participants | 5 Participants |
| NYHA Class 2 | 3 Participants | 2 Participants | 5 Participants |
| 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 4 Participants | 2 Participants | 6 Participants |
| Region of Enrollment United States | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
| Ventricular Arrhythmias | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 3 / 4 | 2 / 3 |
Outcome results
Primary
The Rate of Change in Medical Management With Beta-blockers, Diuretics and Sacubitril/Valsartan (Defined as Initiation, Termination, Switch, or Dosing Adjustment) in the Intervention Group Compared to Usual Care
The rate of change as measured in the number of medications modified during medical management with beta-blockers, diuretics and sacubitril/Valsartan (defined as initiation, termination, switch, or dosing adjustment) in the intervention group compared to usual care will serve as the primary outcome. The (minimum, maximum) values (0,5) and the range (0 - 5) apply to the rate of change of the prespecified medications. The greater the rate of change, the more optimization (better) the intervention is altering medical management to personalize the regimen.
Time frame: 6 Months
Population: The present study enrolled 7 patients randomized to ICM guided Medical Management Group or Conventional Management Control group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ICM Guided Medical Management Group | The Rate of Change in Medical Management With Beta-blockers, Diuretics and Sacubitril/Valsartan (Defined as Initiation, Termination, Switch, or Dosing Adjustment) in the Intervention Group Compared to Usual Care | 3.3 Medications | Standard Deviation 1 |
| Conventional Management Control Group | The Rate of Change in Medical Management With Beta-blockers, Diuretics and Sacubitril/Valsartan (Defined as Initiation, Termination, Switch, or Dosing Adjustment) in the Intervention Group Compared to Usual Care | 1.3 Medications | Standard Deviation 1.2 |
Comparison: Due to the unexpected low enrollment during COVID pandemic, we aimed to primarily focus the limited analysis/description on the primary endpoint and exploratory analysis related to QOLp-value: 0.064Chi-squared
Secondary
Mean Change in Quality of Life Score
The Kansas City Cardiomyopathy Questionnaire (KCCQ) was used to measure Quality of Life from index discharge to 6 months after discharge in the GDMT intervention vs. control (CMT) groups. Mean changes in KCCQ score for the overall summary score in which positive changes are associated with better QOL outcome and negative change associated with worsened outcome. The absolute KCCQ score can range from 0-100 with higher score associated with better outcomes.
Time frame: 6 month
Population: Mean change in KCCQ overall summary score for each group. A positive change is associated with better outcome and a negative change in score is associated with worsening outcome on the KCCQ instrument. The range is 0-100 with a minimum of 0 and a maximum of 100.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ICM Guided Medical Management Group | Mean Change in Quality of Life Score | 7.0 score on a scale | Standard Deviation 15.8 |
| Conventional Management Control Group | Mean Change in Quality of Life Score | -9.4 score on a scale | Standard Deviation 10.4 |