OptiVol for Precision Medical Management of Heart Failure ((OPTIMED-HF))

University of Rochester

Status: Completed

Conditions: Ischemic and Non-ischemic Cardiomyopathy

Treatments: Device: Medtronic ICD with Opti Vol-Monitor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04206501

00003638

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

ICM guided Medical Management Group

Experimental group

Description:

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.

Treatment:

Device: Medtronic ICD with Opti Vol-Monitor

Conventional Management Control Group

No Intervention group

Description:

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.