PREVENT-HF: Prevention of Heart Failure Events With Impedance Cardiography Testing
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Prevention of Heart Failure Events With Impedance Cardiography Testing (PREVENT-HF)|
- Time in days to first heart failure hospitalization following study enrollment compared between study arms [ Designated as safety issue: No ]
- Time in days to the first heart failure hospitalization or all-cause death between study arms (a composite endpoint without weighting) [ Designated as safety issue: No ]
- Number of total heart failure hospitalizations compared between study arms [ Designated as safety issue: No ]
- Improvement in Quality of Life scores compared between study arms at 4, 12, 24, and 52 weeks versus baseline [ Designated as safety issue: No ]
- Improvement in Patient Global Assessment compared between study arms at 4, 12, 24, and 52 weeks versus baseline [ Designated as safety issue: No ]
- NYHA functional class at 4, 12, 24, and 52 weeks versus baseline in the ICG study arm [ Designated as safety issue: No ]
- Prognostic capability of the blinded BioZ score in the Standard Care arm for short-term heart failure events. [ Designated as safety issue: No ]
|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)|
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.
|Device: BioZ Dx|
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.
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409916
|United States, California|
|Sutter Memorial Hospital|
|Sacramento, California, United States, 95815|
|San Diego, California, United States, 92037|
|University of California at San Diego|
|San Diego, California, United States, 92103|
|Principal Investigator:||Milton Packer, MD||University of Texas Southwestern Medical Center|