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

NCT00409916 | Unknown Phase 4 DMC

• 1 other identifier: 06001-M2-124-1-3
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time in days to first heart failure hospitalization following study enrollment compared between study arms

Secondary Outcomes (6)

• Time in days to the first heart failure hospitalization or all-cause death between study arms (a composite endpoint without weighting)

• Number of total heart failure hospitalizations compared between study arms

• Improvement in Quality of Life scores compared between study arms at 4, 12, 24, and 52 weeks versus baseline

• Improvement in Patient Global Assessment compared between study arms at 4, 12, 24, and 52 weeks versus baseline

• NYHA functional class at 4, 12, 24, and 52 weeks versus baseline in the ICG study arm

Study Arms (2)

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.

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.

Device: BioZ Dx

Interventions

BioZ Dx DEVICE

ICG Arm; Standard Care Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CardioDynamics: lead

Study Sites (3)

Sutter Memorial Hospital

Sacramento, California, 95815, United States

RECRUITING

Scripps Clinic

San Diego, California, 92037, United States

RECRUITING

University of California at San Diego

San Diego, California, 92103, United States

RECRUITING

Related Publications (1)

• Packer M, Abraham WT, Mehra MR, Yancy CW, Lawless CE, Mitchell JE, Smart FW, Bijou R, O'Connor CM, Massie BM, Pina IL, Greenberg BH, Young JB, Fishbein DP, Hauptman PJ, Bourge RC, Strobeck JE, Murali S, Schocken D, Teerlink JR, Levy WC, Trupp RJ, Silver MA; Prospective Evaluation and Identification of Cardiac Decompensation by ICG Test (PREDICT) Study Investigators and Coordinators. Utility of impedance cardiography for the identification of short-term risk of clinical decompensation in stable patients with chronic heart failure. J Am Coll Cardiol. 2006 Jun 6;47(11):2245-52. doi: 10.1016/j.jacc.2005.12.071. Epub 2006 May 15.

  PMID: 16750691 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Milton Packer, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celine Peters

CONTACT

858-535-0202; cpeters@cdic.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 8, 2006
• First Posted: December 12, 2006
• Study Start: January 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: June 3, 2009

Record last verified: 2009-06

Locations

US (3)