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

July 19, 2023 updated by: Spencer Rosero, MD, University of Rochester
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICM guided Medical Management Group
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.
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.
No Intervention: Conventional Management Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent changes to medication type reflecting ongoing personalized optimization.
Time Frame: 6 month
Frequency of change in medication type.
6 month
Recurrent changes to medication dosing reflecting ongoing personalized optimization.
Time Frame: 6 month
Frequency of change in medication dose.
6 month
Mean changes in functional status (measured by 6-minute walk distance) in the intervention vs. control groups.
Time Frame: 6 month
measured by 6-minute walk distance
6 month
Percentage change in average daily activity level. This will be measure using an accelerometer which will measure movement by degree and duration of motion.
Time Frame: 6 months
This will be measure using an accelerometer which will measure movement by degree and duration of motion.
6 months
Quality of life (measured by Kansas City Cardiomyopathy Questionnaire) in the intervention vs. control groups.
Time Frame: 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.
6 months
Healthcare utilization as determined by the number of unplanned office visits and hospitalizations in each group.
Time Frame: 12 months
number of unplanned office visits
12 months
Number of Cardiac hospitalizations
Time Frame: 12 months
Number of times patient is hospitalized
12 months
All-cause mortality
Time Frame: 12 month
Mortality:
12 month
Change in Laboratory Biomarkers (BNP-brain natriuretic peptide)
Time Frame: 12 months
BNP-brain natriuretic peptide
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Spencer Z Rosero, MD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2020

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

November 20, 2022

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

December 18, 2019

First Posted (Actual)

December 20, 2019

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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