Status:
UNKNOWN
PREVENT-HF: Prevention of Heart Failure Events With Impedance Cardiography Testing
Lead Sponsor:
CardioDynamics
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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 healt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00409916
Start Date
January 1 2007
End Date
December 1 2012
Last Update
June 3 2009
Active Locations (3)
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1
Sutter Memorial Hospital
Sacramento, California, United States, 95815
2
Scripps Clinic
San Diego, California, United States, 92037
3
University of California at San Diego
San Diego, California, United States, 92103