OptiVol for Precision Medical Management of Heart Failure

Not Applicable

Terminated

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

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Locations (1): University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States