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

Primary Purpose

Ischemic and Non-ischemic Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medtronic ICD with Opti Vol-Monitor
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic and Non-ischemic Cardiomyopathy focused on measuring ICD, OptiVol-Monitor, Cardiac Compass, Garmin Vivo Smart, Guideline Directed Medical Therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ICM guided Medical Management Group

Conventional Management Control Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Recurrent changes to medication type reflecting ongoing personalized optimization.
Frequency of change in medication type.
Recurrent changes to medication dosing reflecting ongoing personalized optimization.
Frequency of change in medication dose.
Mean changes in functional status (measured by 6-minute walk distance) in the intervention vs. control groups.
measured by 6-minute walk distance
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.
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.
Healthcare utilization as determined by the number of unplanned office visits and hospitalizations in each group.
number of unplanned office visits
Number of Cardiac hospitalizations
Number of times patient is hospitalized
All-cause mortality
Mortality:
Change in Laboratory Biomarkers (BNP-brain natriuretic peptide)
BNP-brain natriuretic peptide

Full Information

First Posted
December 10, 2019
Last Updated
July 19, 2023
Sponsor
University of Rochester
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT04206501
Brief Title
OptiVol for Precision Medical Management of Heart Failure
Acronym
(OPTIMED-HF)
Official Title
OptiVol for Precision Medical Management of Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic and Non-ischemic Cardiomyopathy
Keywords
ICD, OptiVol-Monitor, Cardiac Compass, Garmin Vivo Smart, Guideline Directed Medical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICM guided Medical Management Group
Arm Type
Experimental
Arm 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.
Arm Title
Conventional Management Control Group
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Medtronic ICD with Opti Vol-Monitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Recurrent changes to medication type reflecting ongoing personalized optimization.
Description
Frequency of change in medication type.
Time Frame
6 month
Title
Recurrent changes to medication dosing reflecting ongoing personalized optimization.
Description
Frequency of change in medication dose.
Time Frame
6 month
Title
Mean changes in functional status (measured by 6-minute walk distance) in the intervention vs. control groups.
Description
measured by 6-minute walk distance
Time Frame
6 month
Title
Percentage change in average daily activity level. This will be measure using an accelerometer which will measure movement by degree and duration of motion.
Description
This will be measure using an accelerometer which will measure movement by degree and duration of motion.
Time Frame
6 months
Title
Quality of life (measured by Kansas City Cardiomyopathy Questionnaire) in the intervention vs. control groups.
Description
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.
Time Frame
6 months
Title
Healthcare utilization as determined by the number of unplanned office visits and hospitalizations in each group.
Description
number of unplanned office visits
Time Frame
12 months
Title
Number of Cardiac hospitalizations
Description
Number of times patient is hospitalized
Time Frame
12 months
Title
All-cause mortality
Description
Mortality:
Time Frame
12 month
Title
Change in Laboratory Biomarkers (BNP-brain natriuretic peptide)
Description
BNP-brain natriuretic peptide
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Spencer Z Rosero, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19351941
Citation
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.
Results Reference
background
PubMed Identifier
26940927
Citation
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.
Results Reference
background
PubMed Identifier
23381511
Citation
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.
Results Reference
background
PubMed Identifier
23747642
Citation
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.
Results Reference
background

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OptiVol for Precision Medical Management of Heart Failure

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