OptiVol for Precision Medical Management of Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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OptiVol for Precision Medical Management of Heart Failure

Conditions
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Ischemic and Non-ischemic Cardiomyopathy

Intervention / Treatment
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* Device: Medtronic ICD with Opti Vol-Monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICM guided Medical Management Group<br>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. | Device: Medtronic ICD with Opti Vol-Monitor<br>* 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.<br>|
| No Intervention: Conventional Management Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of this study is 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 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent changes to medication type reflecting ongoing personalized optimization. | Frequency of change in medication type. | 6 month | 
| Recurrent changes to medication dosing reflecting ongoing personalized optimization. | Frequency of change in medication dose. | 6 month | 
| Mean changes in functional status (measured by 6-minute walk distance) in the intervention vs. control groups. | measured by 6-minute walk distance | 6 month | 
| Percentage change in average daily activity level. This will be measure using an accelerometer which will measure movement by degree and duration of motion. | This will be measure using an accelerometer which will measure movement by degree and duration of motion. | 6 months | 
| Quality of life (measured by Kansas City Cardiomyopathy Questionnaire) in the intervention vs. control groups. | This consists of 15 questions that refer to heart failure and how it may affect a patients life. the scale is 0-100 with 0 meaning worse. | 6 months | 
| Healthcare utilization as determined by the number of unplanned office visits and hospitalizations in each group. | number of unplanned office visits | 12 months | 
| Number of Cardiac hospitalizations | Number of times patient is hospitalized | 12 months | 
| All-cause mortality | Mortality: | 12 month | 
| Change in Laboratory Biomarkers (BNP-brain natriuretic peptide) | BNP-brain natriuretic peptide | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD, OptiVol-Monitor, Cardiac Compass, Garmin Vivo Smart, Guideline Directed Medical Therapy