Heart Failure, CongestivePhase 4NCT00409916
PREVENT-HF: Prevention of Heart Failure Events With Impedance Cardiography Testing
A Phase 4 study testing BioZ Dx in people with Heart Failure, Congestive, run by CardioDynamics at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- BioZ Dx
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2007to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Sutter Memorial Hospital
Sacramento, California, 95815
Debbie Jacobs, RN, 916-733-8930, jacobsDA@sutterhealth.org
John Chin, MD
- Recruiting
Scripps Clinic
San Diego, California, 92037
Maria Reyes, LVN, 858-554-8931, reyes.maria2@scrippshealth.org
J. Thomas Heywood, M.D.
- Recruiting
University of California at San Diego
San Diego, California, 92103
Geoff van den Brande, RN, 619-543-7723, gvandenbrande@ucsd.edu
Barry Greenberg, MD
About this study
Official title: Prevention of Heart Failure Events With Impedance Cardiography Testing (PREVENT-HF)
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.
Read the 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.
- Conditions
- Heart Failure, Congestive
- Being tested
- BioZ Dx
- Keywords
- chronic heart failure, heart failure, congestive heart failure, impedance cardiography, ICG, transthoracic electrical bioimpedance, non-invasive, TEB
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioZ DxDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: BioZ Dx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Prognostic capability of the blinded BioZ score in the Standard Care arm for short-term heart failure events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardioDynamics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Milton Packer, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409916
- Sponsor's protocol ID
- 06001-M2-124-1-3
- Status last verified
- Jun 2009
- First submitted
- 8 Dec 2006
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16750691
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Heart Failure Events With Impedance Cardiography Testing (PREVENT-HF)
- ClinicalTrials.gov ID
- NCT00409916
- Acronym / sponsor ID
- 06001-M2-124-1-3
- Conditions
- Heart Failure, Congestive
- Keywords
- chronic heart failure, heart failure, congestive heart failure, impedance cardiography, ICG, transthoracic electrical bioimpedance, non-invasive, TEB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- CardioDynamicsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 12 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Arm | Placebo comparator | Device: BioZ DxIn 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. |
| ICG Arm | Active comparator | Device: BioZ DxIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioZ Dx | Device | ICG Arm, Standard Care Arm |
Primary outcome
Time in days to first heart failure hospitalization following study enrollment compared between study arms
6 secondary outcomes
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
Prognostic capability of the blinded BioZ score in the Standard Care arm for short-term heart failure events.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2009.
- Background: PubMed 16750691Packer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milton Packer, MD principal investigator
University of Texas Southwestern Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BioZ Dx in people with Heart Failure, Congestive, run by CardioDynamics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Celine Peters (858-535-0202 ext. 1040, cpeters@cdic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in days to first heart failure hospitalization following study enrollment compared between study arms. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00409916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2009; AzTrials last refreshed its copy on 8 Nov 2026.