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Medtronic ICD with Opti Vol-Monitor for Cardiomyopathy ((OPTIMED-HF) Trial)

N/A

Waitlist Available

Led By Spencer Z Rosero, MD

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

(OPTIMED-HF) Trial Summary

This trial will compare the rate of change in GDMT between a group receiving care from a multidisciplinary team following a pre-specified standard of care model, and a group receiving conventional care.

Eligible Conditions

Cardiomyopathy

(OPTIMED-HF) Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The 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

Secondary outcome measures

All-cause mortality

Change in Laboratory Biomarkers (BNP-brain natriuretic peptide)

Healthcare utilization as determined by the number of unplanned office visits and hospitalizations in each group.

+6 more

(OPTIMED-HF) Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ICM guided Medical Management GroupExperimental Treatment1 Intervention

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.

Group II: Conventional Management Control GroupActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Medtronic ICD with Opti Vol-Monitor

2020

N/A

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor

838 Previous Clinical Trials

518,560 Total Patients Enrolled

2 Trials studying Cardiomyopathy

390 Patients Enrolled for Cardiomyopathy

MedtronicIndustry Sponsor

606 Previous Clinical Trials

828,658 Total Patients Enrolled

6 Trials studying Cardiomyopathy

715 Patients Enrolled for Cardiomyopathy

Spencer Z Rosero, MDPrincipal InvestigatorUniversity of Rochester

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment open to elderly participants?

"The enrollment criteria for this trial requests that participants are aged 18 to 85, with 35 trials avaialble for minors and 813 studies available for seniors."

Answered by AI

How many participants are currently partaking in this medical experiment?

"Indeed, clinicaltrials.gov details that this investigation is actively recruiting participants. Its first posting was on the 5th of February 2020 and its most recent revision occurred on 9th March 2022. The study envisions enrolling 30 patients at 1 site."

Answered by AI

Is this medical experiment currently accessible to participants?

"Affirmative, clinicaltrials.gov displays that this research is still in progress of recruitment. It was first posted on February 5th 2020 and last edited March 9th 2022. The investigators need to locate 30 individuals from 1 centre for the trial currently underway."

Answered by AI

Are there any qualifications for participation in this experiment?

"This cardiomyopathy clinical trial is accepting up to 30 qualified patients aged between 18 and 85. To be eligible, an ICD must have been implanted in accordance with accepted guidelines at least three months prior, the patient must own a smartphone or tablet with Bluetooth and internet access, and their left ventricular dysfunction cannot be attributed to any other reversible cause."

Answered by AI

Recent research and studies

Health AffairsJournal

What the Evidence Shows About Patient Activation: Better Health Outcomes and Care Experiences; Fewer Data on Costs

Hibbard, Judith H., and Jessica Greene. 2013. “What the Evidence Shows About Patient Activation: Better Health Outcomes and Care Experiences; Fewer Data on Costs”. Health Affairs. Health Affairs (Project Hope). doi:10.1377/hlthaff.2012.1061.

Journal of the American College of CardiologyJournal

2013 ACCF/AHA Guideline for the Management of Heart Failure

Yancy, Clyde W., Mariell Jessup, Biykem Bozkurt, Javed Butler, Donald E. Casey Jr., Mark H. Drazner, Gregg C. Fonarow, et al.. 2013. “2013 ACCF/AHA Guideline for the Management of Heart Failure”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2013.05.019.

Journal of the American College of CardiologyJournal

Use of Guideline-directed Medications for Heart Failure Before Cardioverter-defibrillator Implantation

Roth, Gregory A., Jeanne E. Poole, Rebecca Zaha, Weiping Zhou, Jonathan Skinner, and Nancy E. Morden. 2016. “Use of Guideline-directed Medications for Heart Failure Before Cardioverter-defibrillator Implantation”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2015.12.046.

JamaJournal