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Device
OptiVol for Precision Medical Management of Heart Failure ((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
No Placebo-Only Group
Summary
This trial tests if using data from a special heart device can help doctors choose better medications for patients with certain heart conditions. The device provides real-time information about the patient's heart, guiding the medical team in their decisions.
Eligible Conditions
- Cardiomyopathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
871 Previous Clinical Trials
549,811 Total Patients Enrolled
2 Trials studying Cardiomyopathy
390 Patients Enrolled for Cardiomyopathy
MedtronicIndustry Sponsor
619 Previous Clinical Trials
764,081 Total Patients Enrolled
6 Trials studying Cardiomyopathy
715 Patients Enrolled for Cardiomyopathy
Spencer Z Rosero, MDPrincipal InvestigatorUniversity of Rochester