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

NCT02406820 | Terminated

• 1 other identifier: HF001
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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).

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

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).

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

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).

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

Interventions

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

Indwelling PAC, Daily Testing; No Indwelling PAC, Daily Testing; No Indwelling PAC, No Daily Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acutely decompensated heart failure patients admitted to acute care setting, who require a right heart catheterization.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intelomed, Inc.: lead

Study Sites (1)

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010-2975, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• David Majure, MD

  MedStar Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: April 2, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 30, 2016

Record last verified: 2016-08

Locations

US (1)