Clinical trial NCT02406820: Correlating Noninvasive Cardiovascular Measures to Left Ventricular End Diastolic Pressure in Heart Failure
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Lead sponsor: Intelomed, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acutely decompensated heart failure patients admitted to acute care setting, who require a right heart catheterization.

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.


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

Primary outcomes:
measure: Evidence of correlation between CVInsight signals and Pulmonary Capillary Wedge Pressure or Pulmonary Artery Pressure
timeFrame: Upon completion of catheter assessments for all enrolled subjects, approximately 6 months from study activation
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: MedStar Health
name: David Majure, MD
role: PRINCIPAL_INVESTIGATOR
References: