Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in HF Patients (CONFIRM-HF)

Withdrawn

• Conditions: Heart Failure

• Registration Number: NCT02026635
• Lead Sponsor: Thomas Jefferson University

Brief Summary

A research study to determine if heart failure can be medically managed using data collected from cardiac monitoring devices

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-31
• Study First Posted: 2014-01-03
• Status Verified: 2015-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-04
• Last Update Posted: 2015-02-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• At least 18 years of age
• Admission for worsening of HF
• Discharged to home
• Have appropriate cardiac device with OptiVol® implanted for at least 34 days prior to enrollment
• Enrolled in Carelink® system and able to transmit data
• Able to participate for at least 3 months

Exclusion Criteria

• Post heart transplant or actively listed
• End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support
• Stage IV or V chronic renal dysfunction (GFR <25 mol/min per 1.73 M2)
• Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen
• Severe pulmonary hypertension not due to left-sided HF

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physician Use of Cardiac Compass Reports to Determine HF Treatment Decisions	90 days from enrollment	Assessment will be completed at time of enrollment and days 3 to 7, 14 to 21, 30 and 90 post discharge.

Secondary Outcome Measures

Name	Time	Method
Heart Failure Clinical Events	90 days from enrollment	Track HF re-admissions and other clinical encounters between 30 and 90 days post discharge for HF.
Assess Patient-Reported Quality of Life	90 days from enrollment	Assess the association between the use of Cardiac Compass Report and OptiVol® and improved HF patient quality of life at both time points (30 and 90 days post discharge) utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States