NCT02406820

Correlating Noninvasive Cardiovascular Measures to Left Ventricular End Diastolic Pressure in Heart Failure

Characterizing Noninvasive Cardiovascular Measures Collected Passively and In Response to an Isometric Handgrip Stress Test From CVInsight®, Connex ProBP, and Zio® XT Patch in Patients With Acute Decompensated Heart Failure

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: Intelomed, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

HF001 is a prospective observational study utilizing non-invasive medical devices that may be able to discriminate changes in heart failure while acutely decompensated patients undergo routine interventional therapies in a hospital setting. Subjects will be monitored using CVInsight™ \[CVI\] via a finger and/or forehead sensor, while performing an isometric handgrip stress test (IHGST). Changes in the CVI signal will be analyzed and correlated to standard assessments of heart failure including pulmonary artery catheter (PAC) pressures, blood pressure (BP), patient symptoms, and physical exam findings. The results of this study will be used to develop a powered study to determine if a new configuration of non-invasive monitoring devices can be used to monitor heart failure status more sensitively than current non-invasive techniques.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Non-invasive hemodynamic monitoring (CVInsight™ [CVI])

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-04-02
• Last updated: 2016-08-30

Locations

1 site across 1 country: United States