OptiVol for Precision Medical Management of Heart Failure
- Conditions
- Ischemic and Non-ischemic Cardiomyopathy
- Interventions
- Device: Medtronic ICD with Opti Vol-Monitor
- Registration Number
- NCT04206501
- Lead Sponsor
- University of Rochester
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ICM guided Medical Management Group Medtronic ICD with Opti Vol-Monitor 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.
- Primary Outcome Measures
Name Time Method 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 6 Months 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
- Secondary Outcome Measures
Name Time Method Number of Cardiac hospitalizations 12 months Number of times patient is hospitalized
Mean changes in functional status (measured by 6-minute walk distance) in the intervention vs. control groups. 6 month measured by 6-minute walk distance
Recurrent changes to medication type reflecting ongoing personalized optimization. 6 month Frequency of change in medication type.
Percentage change in average daily activity level. This will be measure using an accelerometer which will measure movement by degree and duration of motion. 6 months This will be measure using an accelerometer which will measure movement by degree and duration of motion.
Change in Laboratory Biomarkers (BNP-brain natriuretic peptide) 12 months BNP-brain natriuretic peptide
Recurrent changes to medication dosing reflecting ongoing personalized optimization. 6 month Frequency of change in medication dose.
All-cause mortality 12 month Mortality:
Quality of life (measured by Kansas City Cardiomyopathy Questionnaire) in the intervention vs. control groups. 6 months 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.
Healthcare utilization as determined by the number of unplanned office visits and hospitalizations in each group. 12 months number of unplanned office visits
Trial Locations
- Locations (1)
University of Rochester Medical Center
🇺🇸Rochester, New York, United States