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

August 28, 2016 updated by: Intelomed, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2975
        • Medstar Washington Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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])

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intelomed, Inc.

Investigators

  • Principal Investigator: David Majure, MD, MedStar Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 28, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HF001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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