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

NCT ID: NCT02406820

Last Updated: 2016-08-30

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-03-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

No Indwelling PAC, Daily Testing

Acutely decompensated heart failure patients undergoing a right heart catheterization for whom a retained indwelling PAC is not clinically indicated and who are registered to twice daily non-invasive hemodynamic monitoring during an isometric handgrip stress test (IHGST).

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

Intervention Type: DEVICE

Indwelling PAC, Daily Testing

Acutely decompensated heart failure patients undergoing a right heart catheterization for whom a retained indwelling PAC is clinically indicated and who are registered to three times daily non-invasive hemodynamic monitoring during an isometric handgrip stress test (IHGST).

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

Intervention Type: DEVICE

No Indwelling PAC, No Daily Testing

Acutely decompensated heart failure patients undergoing a right heart catheterization for whom a retained indwelling PAC is clinically indicated and who are registered to no daily non-invasive hemodynamic monitoring during an isometric handgrip stress test (IHGST).

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

Intervention Type: DEVICE

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients ≥ 18 years old
• Signs and symptoms of congestive heart failure including two of the following:
• Peripheral edema (e.g. abdominal distension, hepatomegaly, lower extremity edema) in the setting of elevated jugular venous pressure as assessed by the clinical examination, or by right heart catheterization.
• Pulmonary edema or pleural effusion as seen on chest X-ray
• Elevated N-terminal pro-brain natriuretic peptide (NT-Pro BNP) 2x the upper limit of normal.
• Willing and able to comply with the study protocol
• Willing and able to give valid Informed Consent

Exclusion Criteria

• Pregnant patients
• Presence of Left Ventricular Assist Device (LVAD) or heart transplant
• Complex congenital heart disorder or prosthetic valve on right side
• Known mitral stenosis
• Unstable medical condition or impairment other than condition associated with HF
• Unstable hypertension
• Too unstable in the judgment of the investigator to be included in the study
• Active lung infection or acute pulmonary decompensation
• Elevated white blood cell count and signs of infection are evident
• Does not have the cognitive ability to understand and sign the Informed Consent
• Does not have the cognitive capacity to perform handgrip test
• Is not able to perform a handgrip stress test
• Is not able to wear any of the devices
• Patient's life expectancy is less than 3 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intelomed, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Majure, MD

Role: PRINCIPAL_INVESTIGATOR

MedStar Health

Locations

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

HF001

Identifier Type: -

Identifier Source: org_study_id