Left Ventricular Systolic DysfunctionSCD-HeFT10 YrNCT01058837
SCD-HeFT 10 Year Follow-up
An observational study of Left Ventricular Systolic Dysfunction and Congestive Heart Failure, run by Seattle Institute for Cardiac Research at 1 site in United States.
Trial summary
No clinical trial that has examined the role of implantable cardioverter defibrillator (ICD) therapy in the prevention of Sudden Cardiac Death (SCD) has provided outcome data for longer than a few years. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Left Ventricular Systolic Dysfunction, Congestive Heart Failure, Ischemic and Non-ischemic Cardiomyopathy
- How many people
- 1,855 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2011
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: At the close of follow-up of the original SCD-HeFT study on October 31, 2003 there were a total of 666 deaths out of the enrollment population of 2521 patients. The American Recovery and Reinvestment Act (ARRA) of 2009 offers a perfect opportunity to do a one-time survey of the remaining 1855 patients from our last follow-up of October 31, 2003. Data on this population would allow us to obtain 10 year ICD follow-up data on the most detailed and largest ICD study ever done.
Who may be able to join
- This is a one time follow-up on patients previously enrolled. -
Who cannot join
- This is a one time follow-up on patients previously enrolled.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Institute for Cardiac Research
Bellevue, Washington, 98004-2206
About this study
Official title: Sudden Cardiac Death in Heart Failure Trial 10 Year Follow-up (SCD-HeFT 10 Year)
No clinical trial that has examined the role of implantable cardioverter defibrillator (ICD) therapy in the prevention of Sudden Cardiac Death (SCD) has provided outcome data for longer than a few years. The NHLBI sponsored and placebo-controlled Sudden Cardiac Death in heart Failure Trial (SCD-HeFT) conducted from 1997 to 2003 had the largest number of patients and the longest average follow-up at 45.5 months. This study changed the national reimbursement policy for ICD therapy and remains the reference point for all other ICD evaluations in patients with congestive heart failure from ischemic or non-ischemic systolic dysfunction. Despite the outcome, the role of ICD therapy in the management of patients with heart failure has been questioned because of four principal concerns: numbers needed to treat to save a life, lead integrity over time, the negative consequences of shock therapy, and the cost of therapy. The purpose of this trial is to track down the remaining patients for a one-time follow-up regarding key outcome data.
Read the detailed description
Long-term outcome data for implantable cardioverter defibrillator (ICD) therapy is sorely needed. We will acquire these data by re-approaching the patient population from the original Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).[Bardy 2005] This research is supported by the National Heart Lung and Blood Institute of the National Institutes of Health.
SCD-HeFT was originally conducted from 1997 to 2003. It demonstrated unequivocally that ICD's save lives in patients with heart failure compared to placebo or amiodarone. More than 26 peer-reviewed publications, including three NEJM papers, have resulted from this work.[Bardy 2005, Poole 2008, Mark 2008] Despite the quality of SCD-HeFT and the evidence of the life-saving ability of ICD therapy, the role of ICD therapy in the management of patients with heart failure continues to be questioned. This study will provide long-term follow-up of the SCD-HeFT patients, which will now exceed 10 years on average.
- Conditions
- Left Ventricular Systolic Dysfunction, Congestive Heart Failure, Ischemic and Non-ischemic Cardiomyopathy, Sudden Cardiac Death Primary Prevention
- Keywords
- Sudden Cardiac Death, Implantable Cardioverter Defibrillator, Ventricular Fibrillation
- Medical subject headings
- Ventricular Dysfunction, Left, Heart Failure, Ischemia, Death, Sudden, Cardiac, Ventricular Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare 10-year mortality data on the remaining 1855 SCD-HeFT patients since the close of follow-up from October 31, 2003 in the 3 arms of the trial (ICD, placebo and amiodarone)based upon an intent-to-treat and an on-treatment analysis.
Measured: Two years
Secondary outcomes (5)
To obtain outcome data in the major subgroups of SCD-HeFT: ischemic v. non-ischemic and NYHA Class II vs. Class III heart failure, and in woman and minorities.
Measured: Two years
To obtain 10-year ICD use rates (appropriate and inappropriate therapy), complication rates, lead failure rates and replacement rates.
Measured: Two Years
To validate or refute the observation that amiodarone increases mortality in NYHA Class III patients.
Measured: Two years
To obtain 10-year hospitalization and major procedure data.
Measured: Two years
To obtain 10-year quality of life data.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular Systolic DysfunctionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,855 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Cardiac Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Abbott Medical Devices
- Investigators
- Gust H. Bardy, MD, Principal investigator, Seattle Institute for Cardiac Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058837
- Sponsor's protocol ID
- 1RC1HL100625
- Acronym
- SCD-HeFT10 Yr
- Status last verified
- Feb 2010
- First submitted
- 26 Jan 2010
- Last updated
- 11 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399.
PubMed 15659722Poole JE, Olshansky B, Mark DB, Anderson J, Johnson G, Hellkamp AS, Davidson-Ray L, Fishbein DP, Boineau RE, Anstrom KJ, Reinhall PG, Packer DL, Lee KL, Bardy GH; SCD-HeFT Investigators. Long-Term Outcomes of Implantable Cardioverter-Defibrillator Therapy in the SCD-HeFT. J Am Coll Cardiol. 2020 Jul 28;76(4):405-415. doi: 10.1016/j.jacc.2020.05.061.
PubMed 32703511
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sudden Cardiac Death in Heart Failure Trial 10 Year Follow-up (SCD-HeFT 10 Year)
- ClinicalTrials.gov ID
- NCT01058837
- Acronym / sponsor ID
- SCD-HeFT10 Yr / 1RC1HL100625
- Conditions
- Left Ventricular Systolic Dysfunction, Congestive Heart Failure, Ischemic and Non-ischemic Cardiomyopathy, Sudden Cardiac Death Primary Prevention
- Keywords
- Sudden Cardiac Death, Implantable Cardioverter Defibrillator, Ventricular Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,855 participants (estimated)
- Lead sponsor
- Seattle Institute for Cardiac ResearchUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Abbott Medical Devices
- Study start
- Sep 2009
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 29 Jan 2010 (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.
No clinical trial that has examined the role of implantable cardioverter defibrillator (ICD) therapy in the prevention of Sudden Cardiac Death (SCD) has provided outcome data for longer than a few years. The NHLBI sponsored and placebo-controlled Sudden Cardiac Death in heart Failure Trial (SCD-HeFT) conducted from 1997 to 2003 had the largest number of patients and the longest average follow-up at 45.5 months. This study changed the national reimbursement policy for ICD therapy and remains the reference point for all other ICD evaluations in patients with congestive heart failure from ischemic or non-ischemic systolic dysfunction. Despite the outcome, the role of ICD therapy in the management of patients with heart failure has been questioned because of four principal concerns: numbers needed to treat to save a life, lead integrity over time, the negative consequences of shock therapy, and the cost of therapy. The purpose of this trial is to track down the remaining patients for a one-time follow-up regarding key outcome data.
Detailed description
Long-term outcome data for implantable cardioverter defibrillator (ICD) therapy is sorely needed. We will acquire these data by re-approaching the patient population from the original Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).[Bardy 2005] This research is supported by the National Heart Lung and Blood Institute of the National Institutes of Health.
SCD-HeFT was originally conducted from 1997 to 2003. It demonstrated unequivocally that ICD's save lives in patients with heart failure compared to placebo or amiodarone. More than 26 peer-reviewed publications, including three NEJM papers, have resulted from this work.[Bardy 2005, Poole 2008, Mark 2008] Despite the quality of SCD-HeFT and the evidence of the life-saving ability of ICD therapy, the role of ICD therapy in the management of patients with heart failure continues to be questioned. This study will provide long-term follow-up of the SCD-HeFT patients, which will now exceed 10 years on average.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At the close of follow-up of the original SCD-HeFT study on October 31, 2003 there were a total of 666 deaths out of the enrollment population of 2521 patients. The American Recovery and Reinvestment Act (ARRA) of 2009 offers a perfect opportunity to do a one-time survey of the remaining 1855 patients from our last follow-up of October 31, 2003. Data on this population would allow us to obtain 10 year ICD follow-up data on the most detailed and largest ICD study ever done.
Key inclusion criteria (1 listed)
- This is a one time follow-up on patients previously enrolled. -
Key exclusion criteria (2 listed)
- This is a one time follow-up on patients previously enrolled.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare 10-year mortality data on the remaining 1855 SCD-HeFT patients since the close of follow-up from October 31, 2003 in the 3 arms of the trial (ICD, placebo and amiodarone)based upon an intent-to-treat and an on-treatment analysis.
Time frame: Two years
5 secondary outcomes
To obtain outcome data in the major subgroups of SCD-HeFT: ischemic v. non-ischemic and NYHA Class II vs. Class III heart failure, and in woman and minorities.
Time frame: Two years
To obtain 10-year ICD use rates (appropriate and inappropriate therapy), complication rates, lead failure rates and replacement rates.
Time frame: Two Years
To validate or refute the observation that amiodarone increases mortality in NYHA Class III patients.
Time frame: Two years
To obtain 10-year hospitalization and major procedure data.
Time frame: Two years
To obtain 10-year quality of life data.
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2010.
- Background: PubMed 15659722Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399.
- Derived from this study: PubMed 32703511Poole JE, Olshansky B, Mark DB, Anderson J, Johnson G, Hellkamp AS, Davidson-Ray L, Fishbein DP, Boineau RE, Anstrom KJ, Reinhall PG, Packer DL, Lee KL, Bardy GH; SCD-HeFT Investigators. Long-Term Outcomes of Implantable Cardioverter-Defibrillator Therapy in the SCD-HeFT. J Am Coll Cardiol. 2020 Jul 28;76(4):405-415. doi: 10.1016/j.jacc.2020.05.061.
- Coordinating Center WebsiteLink provided by the sponsor.
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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.
Gust H. Bardy, MD principal investigator
Seattle Institute for Cardiac Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Systolic Dysfunction and Congestive Heart Failure, run by Seattle Institute for Cardiac Research at 1 site 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 1 inclusion and 2 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 11 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
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?
To compare 10-year mortality data on the remaining 1855 SCD-HeFT patients since the close of follow-up from October 31, 2003 in the 3 arms of the trial (ICD, placebo and amiodarone)based upon an intent-to-treat and an on-treatment analysis. (time frame: Two years). 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 NCT01058837, which also lists 2 linked publications.
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 11 Feb 2010.