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

Status unconfirmed · Phase 4

Conditions studied: Heart Failure, Congestive

In brief

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.

Key facts

Study ID

NCT00409916

Run by

CardioDynamics

People needed

500

Starts

2007-01-01

Expected to finish

2012-12-01

Last updated by the study team

2009-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Sutter Memorial Hospital — Sacramento, California, United States (enrolling)
• Scripps Clinic — San Diego, California, United States (enrolling)
• University of California at San Diego — San Diego, California, United States (enrolling)

Full record on ClinicalTrials.gov

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