- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04206501
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
Status
Completed
Conditions
Intervention / Treatment
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
- Name: Elizabeth A Perkins, MS,RN
- Phone Number: 585-275-2494
- Email: elizabeth.perkins@heart.rochester.edu
Study Locations
-
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New York
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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-
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.
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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
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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
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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.
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6 month
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Mean changes in functional status (measured by 6-minute walk distance) in the intervention vs. control groups.
Time Frame: 6 month
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measured by 6-minute walk distance
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6 month
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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
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This will be measure using an accelerometer which will measure movement by degree and duration of motion.
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6 months
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Quality of life (measured by Kansas City Cardiomyopathy Questionnaire) in the intervention vs. control groups.
Time Frame: 6 months
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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.
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6 months
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Healthcare utilization as determined by the number of unplanned office visits and hospitalizations in each group.
Time Frame: 12 months
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number of unplanned office visits
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12 months
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Number of Cardiac hospitalizations
Time Frame: 12 months
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Number of times patient is hospitalized
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12 months
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All-cause mortality
Time Frame: 12 month
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Mortality:
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12 month
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Change in Laboratory Biomarkers (BNP-brain natriuretic peptide)
Time Frame: 12 months
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BNP-brain natriuretic peptide
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12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- 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.
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00003638
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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