Heart Failure Clinical Trial
PREVENT-HF: Prevention of Heart Failure Events With Impedance Cardiography Testing
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.
Full 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 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
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There are 3 Locations for this study
Sacramento California, 95815, United States More Info
Principal Investigator
San Diego California, 92037, United States More Info
Principal Investigator
San Diego California, 92103, United States More Info
Principal Investigator
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