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

Terminated

• Conditions: Heart Failure
• Interventions: Device: Non-invasive hemodynamic monitoring (CVInsight™ [CVI])

• Registration Number: NCT02406820
• Lead Sponsor: Intelomed, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-26
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-02
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-28
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Indwelling PAC, No Daily Testing	Non-invasive hemodynamic monitoring (CVInsight™ [CVI])	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).
No Indwelling PAC, Daily Testing	Non-invasive hemodynamic monitoring (CVInsight™ [CVI])	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).
Indwelling PAC, Daily Testing	Non-invasive hemodynamic monitoring (CVInsight™ [CVI])	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).

Primary Outcome Measures

Name	Time	Method
Evidence of correlation between CVInsight signals and Pulmonary Capillary Wedge Pressure or Pulmonary Artery Pressure	Upon completion of catheter assessments for all enrolled subjects, approximately 6 months from study activation

Trial Locations

Locations (1)

Medstar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States