Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

PREVENT-HF: Prevention of Heart Failure Events With Impedance Cardiography Testing

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by CardioDynamics.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
CardioDynamics
ClinicalTrials.gov Identifier:
NCT00409916
First received: December 8, 2006
Last updated: June 1, 2009
Last verified: June 2009
  Purpose

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
Heart Failure, Congestive
Device: BioZ Dx
Phase 4

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by CardioDynamics:

Primary Outcome Measures:
  • Time in days to first heart failure hospitalization following study enrollment compared between study arms [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409916

Contacts
Contact: Celine Peters 858-535-0202 ext 1040 cpeters@cdic.com

Locations
United States, California
Sutter Memorial Hospital Recruiting
Sacramento, California, United States, 95815
Contact: Debbie Jacobs, RN    916-733-8930    jacobsDA@sutterhealth.org   
Principal Investigator: John Chin, 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.         
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         
Sponsors and Collaborators
CardioDynamics
Investigators
Principal Investigator: Milton Packer, MD University of Texas Southwestern Medical Center
  More Information

Publications:
Responsible Party: Rhonda Rhyne, President, CardioDynamics
ClinicalTrials.gov Identifier: NCT00409916     History of Changes
Other Study ID Numbers: 06001-M2-124-1-3
Study First Received: December 8, 2006
Last Updated: June 1, 2009
Health Authority: United States: Institutional Review Board
United Kingdom: Research Ethics Committee
Canada: Ethics Review Committee

Keywords provided by CardioDynamics:
chronic heart failure
heart failure
congestive heart failure
impedance cardiography
ICG
transthoracic electrical bioimpedance
non-invasive
TEB

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 24, 2014