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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02406820
• Other study ID #: HF001
• Status: Terminated
• Phase: N/A
• First received: March 26, 2015
• Last updated: August 28, 2016
• Start date: April 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: Intelomed, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Intelomed, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No