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

NCT02406820 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2016-08-30

No results posted yet for this study

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

Interventions

DEVICE

Non-invasive hemodynamic monitoring (CVInsight™ [CVI])

Sponsors & Collaborators

  • Intelomed, Inc.

    lead INDUSTRY

Principal Investigators

  • David Majure, MD · MedStar Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02406820 on ClinicalTrials.gov