Congestive Heart FailureNCT00289276
FAST (Fluid Accumulation Status Trial)
A study testing Fluid Status Monitoring (OptiVol™) in people with Congestive Heart Failure and Cardiomyopathy, run by Medtronic Cardiac Rhythm and Heart Failure at 16 sites in 3 countries.
Trial summary
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. Using very low electrical pulses that travel across the inside of the chest cavity, thoracic fluid status monitoring (OptiVol™) can measure the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Cardiomyopathy, Dyspnea
- What is being tested?
- Fluid Status Monitoring (OptiVol™)
- Type of treatment
- Medical device
- How many people
- 156 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Nov 2003to Apr 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects with one of the following implantable cardioverter defibrillators (ICDs): InSync Marquis™, InSync II Marquis™, Marquis® DR, or InSync III Marquis™.
- Subjects with an ICD placed in the upper part of the left or right side of their chest.
- Subjects with a lead (flexible wire that sends electrical signals from the ICD directly to the heart tissue) that is inserted through a vein and placed in the right ventricle (RV) of the heart (a transvenous RV lead).
- Subjects who underwent the ICD implant procedure, or any readjusting of the ICD, 30 days or more prior to enrolling in the study.
Who cannot join
- Subjects who are already enrolled in another clinical study.
- Subjects who have received a heart transplant.
- Subjects who are unable or unwilling to follow the study schedule of visits.
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United States12 sites
Alaska Cardiovascular Research Foundation
Anchorage, Alaska, 99508
Palm Beach Heart Institute
Atlantis, Florida, 33462
Texas Cardiac Arrhythmia Research
Austin, Texas, 78758
Cleveland Clinic Foundation Department of Hear Failure/Transplantation
Cleveland, Ohio, 44195
The Ohio State University Hospital
Columbus, Ohio, 43210
Genesis Medical Center
Davenport, Iowa, 52803
The Pavillion at Doylestown Hospital
Doylestown, Pennsylvania, 18901
Duke University Medical Center
Durham, North Carolina, 27710
Fort Wayne Cardiology
Fort Wayne, Indiana, 46805
North Shore University Hospital
Manhasset, New York, 11030
Michigan Cardiovascular Institute
Saginaw, Michigan, 48601
Intermountain Medical Center
Salt Lake City, Utah, 84157
Canada2 sites
University of Calgary/Foothills Hospital
Calgary, Alberta, T2N 4N1
Kingston General Hospital
Kingston, Ontario, K7V 2V7
China2 sites
Queen Mary Hospital
Pok Fu Lam, Hong Kong
Prince of Wales Hospital/The Chinese University of Hong Kong
Shatin, Hong Kong
About this study
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. Using very low electrical pulses that travel across the inside of the chest cavity, thoracic fluid status monitoring (OptiVol™) can measure the level of resistance to the electrical pulses, which indicates the level of fluid in the chest. The purpose of this study is to collect information related to fluid build up in the chest of subjects with heart failure.
- Being tested
- Fluid Status Monitoring (OptiVol™)
- Keywords
- Cardiomyopathy, Ventricular Ejection Fraction, Congestive Heart Failure, Impedance
- Medical subject headings
- Heart Failure, Cardiomyopathies, Dyspnea, Pulmonary Edema, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid Status Monitoring (OptiVol™)Device
Thoracic Fluid Status Software downloaded on all subjects enrolled in the trial
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With at Least 30 Days of Daily Impedance Measurements
Impedance measurements were presented graphically over time in relation to clinical events for all subjects with at least 30 days of follow-up and impedance data collected during the follow-up period.
Measured: Up to 36 months.
Secondary outcomes (3)
Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF
Difference in mean thoracic impedance: post-hospitalization minus pre-hospitalization.
Measured: 3 days pre-admission and 3 days post-discharge
Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF
Difference in mean thoracic impedance: post-outpatient visit minus pre-outpatient visit.
Measured: 1 day pre and 1 day post-outpatient visit
Number of Adverse Events
All adverse events were collected for this trial such as (but not limited to): Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu
Measured: From enrollment to study exit (up to 36 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study startNov 2003
- Primary completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congestive Heart FailureStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289276
- Sponsor's protocol ID
- 228
- Status last verified
- Oct 2010
- First submitted
- 7 Feb 2006
- Last updated
- 13 Oct 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAST (Fluid Accumulation Status Trial)
- ClinicalTrials.gov ID
- NCT00289276
- Acronym / sponsor ID
- 228
- Keywords
- Cardiomyopathy, Ventricular Ejection Fraction, Congestive Heart Failure, Impedance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Apr 2008 (actual)
- First posted
- 9 Feb 2006 (estimated)
- Results
- Posted 28 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. Using very low electrical pulses that travel across the inside of the chest cavity, thoracic fluid status monitoring (OptiVol™) can measure the level of resistance to the electrical pulses, which indicates the level of fluid in the chest. The purpose of this study is to collect information related to fluid build up in the chest of subjects with heart failure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with one of the following implantable cardioverter defibrillators (ICDs): InSync Marquis™, InSync II Marquis™, Marquis® DR, or InSync III Marquis™.
- Subjects with an ICD placed in the upper part of the left or right side of their chest.
- Subjects with a lead (flexible wire that sends electrical signals from the ICD directly to the heart tissue) that is inserted through a vein and placed in the right ventricle (RV) of the heart (a transvenous RV lead).
- Subjects who underwent the ICD implant procedure, or any readjusting of the ICD, 30 days or more prior to enrolling in the study.
Key exclusion criteria (3 listed)
- Subjects who are already enrolled in another clinical study.
- Subjects who have received a heart transplant.
- Subjects who are unable or unwilling to follow the study schedule of visits.
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 |
|---|---|---|
| Fluid Status Monitoring (OptiVol™)Thoracic Fluid Status Software downloaded on all subjects enrolled in the trial | Device | – |
Primary outcome
Number of Subjects With at Least 30 Days of Daily Impedance Measurements
Time frame: Up to 36 months.
Impedance measurements were presented graphically over time in relation to clinical events for all subjects with at least 30 days of follow-up and impedance data collected during the follow-up period.
3 secondary outcomes
Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF
Time frame: 3 days pre-admission and 3 days post-discharge
Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF
Time frame: 1 day pre and 1 day post-outpatient visit
Number of Adverse Events
Time frame: From enrollment to study exit (up to 36 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid Status Monitoring (OptiVol™) in people with Congestive Heart Failure and Cardiomyopathy, run by Medtronic Cardiac Rhythm and Heart Failure at 16 sites in 3 countries.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada, China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With at Least 30 Days of Daily Impedance Measurements (time frame: Up to 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2010.