Recruiting

Impedance Cardiography

Sponsor:

CardioDynamics

Code:

NCT00409916

Conditions

Heart Failure, Congestive

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BioZ Dx

Study Details

Brief summary:

The purpose of this study is to determine whether outpatient therapeutic management guided by impedance cardiography (ICG), in addition to standard clinical assessment, will result in a longer time in days to the first heart failure hospitalization than therapy guided by clinical assessment alone.

Conditions

Heart Failure, Congestive

Study ID

NCT00409916

Start date

Jan, 2007

Status verified date

Jun, 2009

Completion date

Dec, 2012

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Discharge within 12 days from a hospitalization with the primary diagnosis of heart failure
  • Age 18 years or older
  • Chronic heart failure of at least 2 months' duration due to an ischemic or nonischemic etiology
  • Receiving medications for heart failure that are considered (in the judgment of their physician) as being appropriate for their clinical status
  • Able to acquire data successfully with the BioZ device
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Height < 48 inches or > 90 inches (< 120 cm or > 230 cm); weight < 67 lbs or > 341 lbs (<30 kg or >155 kg)
  • Acute heart failure due to myocarditis, cor pulmonale, congenital heart disease, constrictive pericarditis, or hypertrophic, restrictive or obstructive cardiomyopathy
  • Presence of severe aortic regurgitation
  • Acute coronary syndrome (myocardial infarction or unstable angina) or coronary revascularization procedure (coronary bypass surgery or angioplasty) within 2 months
  • History of resuscitated sudden death, ventricular fibrillation, or hemodynamically destabilizing VT unless treated with a properly functioning ICD
  • One or more episodes of ventricular fibrillation or hemodynamically destabilizing ventricular tachycardia within the previous 30 days
  • Second degree - Mobitz Type II or third degree heart block, unless treated with a cardiac pacemaker
  • Implantation of a left ventricular assist device, hemodynamic monitor, activated minute ventilation pacemaker, or biventricular pacemaker (cardiac resynchronization therapy) with the V-to-V interval set at more than 5 milliseconds offset
  • Implantation of a CRT (cardiac resynchronization therapy) device within the previous 30 days
  • Planned implantation of a CRT within the next 6 months
  • Clinician use of intrathoracic impedance data from an implanted pacemaker with this capability
  • Participation in a transtelephonic or internet-based formal monitoring program
  • Most recent serum creatinine > 3 mg/dl; any liver function test (ALT, AST or bilirubin) > 3 times the upper limit of normal; chronic dialysis; or chronic ultrafiltration
  • Plan to serially monitor B-type natriuretic peptide (BNP) or N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) as part of outpatient management
  • Post-discharge management with outpatient infusions
  • Pulmonary disease sufficient to significantly limit exercise or requiring long-term treatment with oral corticosteroids
  • Known hypersensitivity or allergies to sensor gel or adhesive; skin lesions that prohibit adequate sensor placement
  • Women known to be pregnant or who are planning to become pregnant in the next 12 months
  • Current participation in other investigational drug or device protocols, with the exceptions of registries and subjects in long-term safety follow-up with no active treatment for at least 60 days
  • Subjects with a disorder other than heart failure that might be expected to compromise their survival within the next 12 months

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

placebo comparator: Standard Care Arm

In the Standard Care Arm, the treating clinician will adjust therapy according only to the clinical assessment of signs and symptoms of heart failure since the ICG information is blinded to the treating clinician.

active comparator: ICG Arm

In the ICG Arm, the treating clinician will adjust therapy according to the clinical assessment of signs and symptoms of heart failure, in addition to the ICG hemodynamic information obtained from the printed report.

Interventions

BioZ Dx

Primary outcome measure

  • Time in days to first heart failure hospitalization following study enrollment compared between study arms [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Celine Peters

858-535-0202cpeters@cdic.com

Locations

Sutter Memorial Hospital

Recruiting

Sacramento, California, United States, 95815

Contacts

Debbie Jacobs, RN

916-733-8930jacobsDA@sutterhealth.org

Principal Investigator:

John Chin, MD

Scripps Clinic

Recruiting

San Diego, California, United States, 92037

Contacts

Maria Reyes, LVN

858-554-8931reyes.maria2@scrippshealth.org

Principal Investigator:

J. Thomas Heywood, M.D.

University of California at San Diego

Recruiting

San Diego, California, United States, 92103

Contacts

Geoff van den Brande, RN

619-543-7723gvandenbrande@ucsd.edu

Principal Investigator:

Barry Greenberg, MD

More Information

Sponsor

CardioDynamics

Last update posted

Jun 3, 2009

Last verified

Jun, 2009

Keywords

  • chronic heart failure
  • heart failure
  • congestive heart failure
  • impedance cardiography
  • ICG
  • transthoracic electrical bioimpedance
  • non-invasive
  • TEB

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CardioDynamics on 2009-06-03.