Heart FailureNCT02693509
Get With The Guidelines-Heart Failure Registry
An observational study of Heart Failure, run by American Heart Association at 1 site in United States.
Trial summary
Get With The Guidelines-Heart Failure is designed to improve the quality of care in patients hospitalized with heart failure. The program aims to help ensure that eligible patients are initiated on guideline recommended therapies and receive appropriate counseling prior to hospital discharge. Read more about this study
- Who is it for?
- Ages 18 to 125 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- GWTG Heart Failure program
- How many people
- 128,026 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2040
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 125 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study populations is primary diagnosis or secondary diagnosis of heart failure
Who may be able to join
- Patients hospitalized with congestive heart failure.
Who cannot join
- Patients who do not have congestive heart failure,
- Patients under age of 18,
- Patients not admitted as inpatients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Amy Bennett
Dallas, Texas, 75231
Amy Bennett, JD, 214-707-4881, amy.bennett@heart.org
Christine Rutan, christine.rutan@heart.org
About this study
Get With The Guidelines-Heart Failure is designed to improve the quality of care in patients hospitalized with heart failure. The program aims to help ensure that eligible patients are initiated on guideline recommended therapies and receive appropriate counseling prior to hospital discharge.
Read the detailed description
Get With The Guidelines-Heart Failure was initiated in 2005 with over 500 U.S. hospitals participating is designed to improve the quality of care in patients hospitalized with heart failure. The program aims to help ensure that eligible patients are initiated on guideline recommended therapies and receive appropriate counseling prior to hospital discharge.
Peer-reviewed research(with over 35 manuscripts) has demonstrated that through participating in Get With The Guidelines-Heart Failure, hospitals will provide equitable care (regardless of race, ethnicity, age, or gender), the importance of scheduled physician follow-up after heart failure hospital discharge, the value in device-support as necessary for the acute heart failure patient, and many other significant findings.
Achievement measures tracked through Get With The Guidelines-Heart Failure:
- Angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) at discharge
- Evidence-based specific beta blockers
- Measure left ventricular function
- Post-discharge appointment for heart failure patients
Quality Measures tracked through Get With The Guidelines-Heart Failure:
- Mineralocorticoid receptor antagonist at discharge
- Aldosterone antagonist at discharge
- Anticoagulation for atrial fibrillation
- Hydralazine nitrate at discharge
- DVT prophylaxis
- CRT-D or CRT-P placed or prescribed at discharge
- ICD counseling, or ICD placed or prescribed at discharge
- Influenza vaccination during flu season
- Pneumococcal vaccination
- Follow-up visit within 7 days or less
- Lab monitoring follow-up
- SGLT-2 inhibitor at discharge
- Defect-free care for quadruple therapy medication for patients with heart failure with reduced ejection fraction
- Direct-acting oral anticoagulant at discharge for non-valvular atrial fibrillation or atrial flutter patients
Additional measures collected by Get With The Guidelines-Heart Failure can be viewed at: http://www.heart.org/idc/groups/heart-public/@wcm/@private/@hcm/@gwtg/documents/downloadable/ucm_310967.pdf
- Conditions
- Heart Failure
- Being tested
- GWTG Heart Failure program
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GWTG Heart Failure programOther
Evidence based guideline recommended therapies and counseling prior to hospital discharge
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day readmission rate
Percent of index encounters where there is a readmission within 30 days
Measured: 30 days post discharge from hospital
60 day readmission rate
Percent of index encounters where there is a readmission within 60 days
Measured: 60 days post discharge from hospital
90 day readmission rate
Percent of index encounters where there is a readmission within 90 days
Measured: 90 days post discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startJan 2005
- Primary completionJan 2040 (estimated)
- Study completionJan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 128,026 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- American Heart Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javed Butler, MD, Study director, American Heart Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693509
- Sponsor's protocol ID
- GWTG01
- Status last verified
- Jan 2025
- First submitted
- 8 Apr 2013
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.
PubMed 23747642American Academy of Family Physicians; American Academy of Hospice and Palliative Medicine; American Nurses Association; American Society of Health-System Pharmacists; Heart Rhythm Society; Society of Hospital Medicine; Bonow RO, Ganiats TG, Beam CT, Blake K, Casey DE Jr, Goodlin SJ, Grady KL, Hundley RF, Jessup M, Lynn TE, Masoudi FA, Nilasena D, Pina IL, Rockswold PD, Sadwin LB, Sikkema JD, Sincak CA, Spertus J, Torcson PJ, Torres E, Williams MV, Wong JB; ACCF/AHA Task Force on Performance Measures; Peterson ED, Masoudi FA, DeLong E, Erwin JP 3rd, Fonarow GC, Goff DC Jr, Grady KL, Green LA, Heidenreich PA, Jenkins KJ, Loth A, Shahian DM. ACCF/AHA/AMA-PCPI 2011 performance measures for adults with heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures and the American Medical Association-Physician Consortium for Performance Improvement. J Am Coll Cardiol. 2012 May 15;59(20):1812-32. doi: 10.1016/j.jacc.2012.03.013. Epub 2012 Apr 23. No abstract available.
PubMed 22534627Rao VN, Mentz RJ, Coniglio AC, Kelsey MD, Fudim M, Fonarow GC, Matsouaka RA, DeVore AD, Caughey MC. Neighborhood Socioeconomic Disadvantage and Hospitalized Heart Failure Outcomes in the American Heart Association Get With The Guidelines-Heart Failure Registry. Circ Heart Fail. 2022 Nov;15(11):e009353. doi: 10.1161/CIRCHEARTFAILURE.121.009353. Epub 2022 Nov 15.
PubMed 36378758
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get With The Guidelines-Heart Failure Registry
- ClinicalTrials.gov ID
- NCT02693509
- Acronym / sponsor ID
- GWTG01
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 128,026 participants (estimated)
- Lead sponsor
- American Heart AssociationUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2040 (estimated)
- Study completion
- Jan 2040 (estimated)
- First posted
- 26 Feb 2016 (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.
Get With The Guidelines-Heart Failure is designed to improve the quality of care in patients hospitalized with heart failure. The program aims to help ensure that eligible patients are initiated on guideline recommended therapies and receive appropriate counseling prior to hospital discharge.
Detailed description
Get With The Guidelines-Heart Failure was initiated in 2005 with over 500 U.S. hospitals participating is designed to improve the quality of care in patients hospitalized with heart failure. The program aims to help ensure that eligible patients are initiated on guideline recommended therapies and receive appropriate counseling prior to hospital discharge.
Peer-reviewed research(with over 35 manuscripts) has demonstrated that through participating in Get With The Guidelines-Heart Failure, hospitals will provide equitable care (regardless of race, ethnicity, age, or gender), the importance of scheduled physician follow-up after heart failure hospital discharge, the value in device-support as necessary for the acute heart failure patient, and many other significant findings.
Achievement measures tracked through Get With The Guidelines-Heart Failure:
- Angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) at discharge
- Evidence-based specific beta blockers
- Measure left ventricular function
- Post-discharge appointment for heart failure patients
Quality Measures tracked through Get With The Guidelines-Heart Failure:
- Mineralocorticoid receptor antagonist at discharge
- Aldosterone antagonist at discharge
- Anticoagulation for atrial fibrillation
- Hydralazine nitrate at discharge
- DVT prophylaxis
- CRT-D or CRT-P placed or prescribed at discharge
- ICD counseling, or ICD placed or prescribed at discharge
- Influenza vaccination during flu season
- Pneumococcal vaccination
- Follow-up visit within 7 days or less
- Lab monitoring follow-up
- SGLT-2 inhibitor at discharge
- Defect-free care for quadruple therapy medication for patients with heart failure with reduced ejection fraction
- Direct-acting oral anticoagulant at discharge for non-valvular atrial fibrillation or atrial flutter patients
Additional measures collected by Get With The Guidelines-Heart Failure can be viewed at: http://www.heart.org/idc/groups/heart-public/@wcm/@private/@hcm/@gwtg/documents/downloadable/ucm_310967.pdf
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 125 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study populations is primary diagnosis or secondary diagnosis of heart failure
Key inclusion criteria (1 listed)
- Patients hospitalized with congestive heart failure.
Key exclusion criteria (3 listed)
- Patients who do not have congestive heart failure,
- Patients under age of 18,
- Patients not admitted as inpatients.
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 |
|---|---|---|
| GWTG Heart Failure programEvidence based guideline recommended therapies and counseling prior to hospital discharge | Other | – |
Primary outcome
30 day readmission rate
Time frame: 30 days post discharge from hospital
Percent of index encounters where there is a readmission within 30 days
60 day readmission rate
Time frame: 60 days post discharge from hospital
Percent of index encounters where there is a readmission within 60 days
90 day readmission rate
Time frame: 90 days post discharge from hospital
Percent of index encounters where there is a readmission within 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Background: PubMed 23747642Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.
- Background: PubMed 22534627American Academy of Family Physicians; American Academy of Hospice and Palliative Medicine; American Nurses Association; American Society of Health-System Pharmacists; Heart Rhythm Society; Society of Hospital Medicine; Bonow RO, Ganiats TG, Beam CT, Blake K, Casey DE Jr, Goodlin SJ, Grady KL, Hundley RF, Jessup M, Lynn TE, Masoudi FA, Nilasena D, Pina IL, Rockswold PD, Sadwin LB, Sikkema JD, Sincak CA, Spertus J, Torcson PJ, Torres E, Williams MV, Wong JB; ACCF/AHA Task Force on Performance Measures; Peterson ED, Masoudi FA, DeLong E, Erwin JP 3rd, Fonarow GC, Goff DC Jr, Grady KL, Green LA, Heidenreich PA, Jenkins KJ, Loth A, Shahian DM. ACCF/AHA/AMA-PCPI 2011 performance measures for adults with heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures and the American Medical Association-Physician Consortium for Performance Improvement. J Am Coll Cardiol. 2012 May 15;59(20):1812-32. doi: 10.1016/j.jacc.2012.03.013. Epub 2012 Apr 23. No abstract available.
- Derived from this study: PubMed 36378758Rao VN, Mentz RJ, Coniglio AC, Kelsey MD, Fudim M, Fonarow GC, Matsouaka RA, DeVore AD, Caughey MC. Neighborhood Socioeconomic Disadvantage and Hospitalized Heart Failure Outcomes in the American Heart Association Get With The Guidelines-Heart Failure Registry. Circ Heart Fail. 2022 Nov;15(11):e009353. doi: 10.1161/CIRCHEARTFAILURE.121.009353. Epub 2022 Nov 15.
- Individual participant dataSharing planned: Undecided
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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.
Javed Butler, MD study director
American Heart Association
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 Heart Failure, run by American Heart Association 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 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: looking for participants now, as of the sponsor's last update on 29 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Bennett, JD (214-706-4881, amy.bennett@heart.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day readmission rate (time frame: 30 days post discharge from hospital). The study lists 3 primary outcomes in all. 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 NCT02693509, which also lists 3 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 29 Jan 2025.