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Sponsored by: |
CardioDynamics |
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Information provided by: | CardioDynamics |
ClinicalTrials.gov Identifier: | NCT00409916 |
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.
Condition | Intervention | Phase |
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Heart Failure, Congestive |
Device: BioZ Dx |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prevention of Heart Failure Events With Impedance Cardiography Testing (PREVENT-HF) |
Estimated Enrollment: | 500 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Standard Care Arm: Placebo Comparator
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.
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Device: BioZ Dx |
ICG Arm: Active Comparator
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.
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Device: BioZ Dx |
The course of patients with chronic heart failure is marked by periodic episodes of clinical decompensation that not only impair the quality of life and may be fatal but also consume substantial health care resources, primarily due to the costs of hospitalization. Heart failure management programs have been developed to reduce the frequency and severity of these clinical events, but their effectiveness may be limited by physicians' difficulty in identifying patients at imminent risk. Reliable prediction of these events may afford physicians the opportunity to intervene aggressively and potentially minimize the need for hospitalization or the risk of a serious adverse outcome.
Noninvasive impedance cardiography (ICG) is a simple test that utilizes changes in thoracic electrical impedance to measure thoracic fluid content, changes in the duration of cardiac ejection and the velocity of blood flow within the aorta. ICG has been used to estimate cardiac output and cardiac filling pressure in patients with or without heart failure (HF).
PREVENT-HF is a randomized prospective study being conducted at up to 35 experienced investigative centers from the United States, Canada, and Europe. Subjects will be enrolled within 4-12 days of a discharge from a hospitalization for exacerbation of heart failure, with screening procedures to occur prior to the enrollment.
Following enrollment, subjects will be randomized in a 1:1 ratio to outpatient management by either clinical assessment (Standard Care Arm) or ICG in addition to clinical assessment (ICG Arm) during the enrollment visit.
ICG variables will be collected in all subjects but will be blinded in the Standard Care Arm. Each subject's study participation will last for a minimum of 24 weeks and a maximum of 52 weeks post-discharge. Four weeks after hospital discharge, subjects will visit the clinic. Remaining study visits will occur every four weeks thereafter until the subject has completed the 52-week visit or until the subject has experienced a hospitalization that has been adjudicated by the Clinical Events Committee as being a heart failure hospitalization.
In the PREDICT study, a composite ICG score was the most powerful predictor of a short-term HF event when compared to standard clinical variables. This composite ICG score is provided for subjects in the PREVENT-HF ICG Arm. If the score indicates a subject is at a higher risk for a short-term HF event, clinicians will be required to intervene. Clinicians may intervene if indicated by the subject's clinical status for an intermediate-risk score, and intervention is not recommended based on the ICG score for lower-risk scores. Compliance to these guidelines will be tracked.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Celine Peters | 858-535-0202 ext 1040 | cpeters@cdic.com |
United States, California | |
University of California at San Diego | Recruiting |
San Diego, California, United States, 92103 | |
Contact: Geoff van den Brande, RN 619-543-7723 gvandenbrande@ucsd.edu | |
Principal Investigator: Barry Greenberg, MD | |
Scripps Clinic | Recruiting |
San Diego, California, United States, 92037 | |
Contact: Maria Reyes, LVN 858-554-8931 reyes.maria2@scrippshealth.org | |
Principal Investigator: J. Thomas Heywood, M.D. | |
Sutter Memorial Hospital | Recruiting |
Sacramento, California, United States, 95815 | |
Contact: Debbie Jacobs, RN 916-733-8930 jacobsDA@sutterhealth.org | |
Principal Investigator: John Chin, MD |
Principal Investigator: | Milton Packer, MD | University of Texas Southwestern Medical Center |
Responsible Party: | CardioDynamics ( Rhonda Rhyne, President ) |
Study ID Numbers: | 06001-M2-124-1-3 |
Study First Received: | December 8, 2006 |
Last Updated: | June 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00409916 History of Changes |
Health Authority: | United States: Institutional Review Board; United Kingdom: Research Ethics Committee; Canada: Ethics Review Committee |
chronic heart failure heart failure congestive heart failure impedance cardiography |
ICG transthoracic electrical bioimpedance non-invasive TEB |
Heart Failure Heart Diseases |
Heart Failure Heart Diseases Cardiovascular Diseases |