OptiVol for Precision Medical Management of Heart Failure

Ischemic and Non-ischemic Cardiomyopathy Clinical Trial

— (OPTIMED-HF)  

Official title:

OptiVol for Precision Medical Management of Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206501
• Other study ID #: 00003638
• Status: Completed
• Phase: N/A
• Start date: February 5, 2020
• Est. completion date: November 20, 2022

Study information

• Verified date: July 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 20, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Ischemic and Non-ischemic Cardiomyopathy

Intervention

Device:
• Medtronic ICD with Opti Vol-Monitor
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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 Months
Secondary	Recurrent changes to medication type reflecting ongoing personalized optimization.	Frequency of change in medication type.	6 month
Secondary	Recurrent changes to medication dosing reflecting ongoing personalized optimization.	Frequency of change in medication dose.	6 month
Secondary	Mean changes in functional status (measured by 6-minute walk distance) in the intervention vs. control groups.	measured by 6-minute walk distance	6 month
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	Healthcare utilization as determined by the number of unplanned office visits and hospitalizations in each group.	number of unplanned office visits	12 months
Secondary	Number of Cardiac hospitalizations	Number of times patient is hospitalized	12 months
Secondary	All-cause mortality	Mortality:	12 month
Secondary	Change in Laboratory Biomarkers (BNP-brain natriuretic peptide)	BNP-brain natriuretic peptide	12 months