OptiVol for Precision Medical Management of Heart Failure

NCT04206501 | Terminated Results DMC FDA Device

• 1 other identifier: 00003638
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic and Non-ischemic Cardiomyopathy

Keywords

ICD; OptiVol-Monitor; Cardiac Compass; Garmin Vivo Smart; Guideline Directed Medical Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Months

Secondary Outcomes (1)

• Mean Change in Quality of Life Score

  6 month

Study Arms (2)

ICM guided Medical Management Group

EXPERIMENTAL

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

Conventional Management Control Group

NO INTERVENTION

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.

Interventions

Medtronic ICD with Opti Vol-Monitor DEVICE

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.

ICM guided Medical Management Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Medtronic: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (4)

• O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Pina IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454.

  PMID: 19351941 BACKGROUND

• Roth GA, Poole JE, Zaha R, Zhou W, Skinner J, Morden NE. Use of Guideline-Directed Medications for Heart Failure Before Cardioverter-Defibrillator Implantation. J Am Coll Cardiol. 2016 Mar 8;67(9):1062-1069. doi: 10.1016/j.jacc.2015.12.046.

  PMID: 26940927 BACKGROUND

• Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.

  PMID: 23381511 BACKGROUND

• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.

  PMID: 23747642 BACKGROUND

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination due to COVID Pandemic leading to small numbers of subjects analyzed which limits interpretation of the data.

Results Point of Contact

• Title: Spencer Z. Rosero, M.D.
• Organization: University of Rochester Medical Center

spencer_rosero@urmc.rochester.edu

5852752756

Study Officials

• Spencer Z Rosero, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Medicine M&D-Cardiology Div

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 20, 2019
• Study Start: February 5, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 20, 2022
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)