Heart Failure, CongestiveNCT00366639
Registry for Acute Decompensated Heart Failure Patients
An observational study of Heart Failure, Congestive and Heart Decompensation, run by Scios, Inc..
Trial summary
The purpose of the ADHERE study is to develop a multi-center, observational, open-label registry of the management strategies of patients treated in the hospital for acute Heart Failure in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive, Heart Decompensation
- What is being tested?
- Acute Decompensated Heart Failure
- How many people
- 24,118 participants
- Where
- No sites listed yet
- Study dates
- Oct 2001to Feb 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive adult patients admitted to an acute care hospital and treated actively for acute HF, where acute HF is defined clinically as a new onset with HF decompensation
Who may be able to join
- Age greater than or equal to 18 years at the time of admission to the hospital
- Received or is eligible to receive a principal hospital discharge diagnosis of HF
- Decompensated HF is present as determined clinically by the patient care team
Who cannot join
- HF is present as a co-morbid condition, but is not a principal focus of diagnosis or treatment during this hospitalization episode
About this study
Official title: ADHERE Core III - Acute Decompensated Heart Failure Registry
The purpose of the ADHERE study is to develop a multi-center, observational, open-label registry of the management strategies of patients treated in the hospital for acute Heart Failure in the United States.
Read the detailed description
The objective is to compile a clinical database on the strategy for the medical management of patients hospitalized with acute Heart Failure (HF). Through the use of the information collected from acute care hospitals across the United States the following information may be coming out of this study: 1) Assist hospitals in evaluating and improving quality of care for patients with acute HF by tracking quality indicators and providing benchmark data reports; 2) Describe the demographic and clinical characteristics of patients who are hospitalized with acute HF; 3) Characterize the initial emergency department evaluation and subsequent inpatient management of patients hospitalized with acute HF; 4) Identify patient characteristics and medical care practices associated with improved health outcomes in those hospitalized with acute HF; 5) Characterize trends and changes over time in the management of acute HF; 6) Offer surveillance of adherence to practice guidelines as these emerge for the inpatient management of acute HF. Observational Study - No investigational drug administered
- Conditions
- Heart Failure, Congestive, Heart Decompensation
- Being tested
- Acute Decompensated Heart Failure
- Keywords
- Heart failure, congestive, Heart decompensation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Decompensated Heart FailureOther
Treatment \& outcomes during hospital admission for Acute DHF
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Other: Acute Decompensated Heart Failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of care in the Emergency Department (ED) and course of care in the inpatient hospital, use of diuretics (increase urine excretion) vasodilators (relax artey and veins) and inotropeic agents (increase the function of the heart) rate of death
Measured: From admission to discharge from the hospital
Secondary outcomes (1)
Data from patient demographics ( sex, age, gender, race)
Measured: at patients admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startOct 2001
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24,118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scios, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scios, Inc. Clinical Trial, Study director, Scios, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366639
- Sponsor's protocol ID
- CR005194
- Status last verified
- Oct 2009
- First submitted
- 18 Aug 2006
- Last updated
- 2 Nov 2009
- Results posted
- No
Publications
Kociol RD, Hammill BG, Fonarow GC, Klaskala W, Mills RM, Hernandez AF, Curtis LH. Generalizability and longitudinal outcomes of a national heart failure clinical registry: Comparison of Acute Decompensated Heart Failure National Registry (ADHERE) and non-ADHERE Medicare beneficiaries. Am Heart J. 2010 Nov;160(5):885-92. doi: 10.1016/j.ahj.2010.07.020.
PubMed 21095276Maisel AS, Peacock WF, McMullin N, Jessie R, Fonarow GC, Wynne J, Mills RM. Timing of immunoreactive B-type natriuretic peptide levels and treatment delay in acute decompensated heart failure: an ADHERE (Acute Decompensated Heart Failure National Registry) analysis. J Am Coll Cardiol. 2008 Aug 12;52(7):534-40. doi: 10.1016/j.jacc.2008.05.010.
PubMed 18687247Kamath SA, Drazner MH, Wynne J, Fonarow GC, Yancy CW. Characteristics and outcomes in African American patients with decompensated heart failure. Arch Intern Med. 2008 Jun 9;168(11):1152-8. doi: 10.1001/archinte.168.11.1152.
PubMed 18541822Peacock WF 4th, De Marco T, Fonarow GC, Diercks D, Wynne J, Apple FS, Wu AH; ADHERE Investigators. Cardiac troponin and outcome in acute heart failure. N Engl J Med. 2008 May 15;358(20):2117-26. doi: 10.1056/NEJMoa0706824.
PubMed 18480204Fonarow GC, Peacock WF, Horwich TB, Phillips CO, Givertz MM, Lopatin M, Wynne J; ADHERE Scientific Advisory Committee and Investigators. Usefulness of B-type natriuretic peptide and cardiac troponin levels to predict in-hospital mortality from ADHERE. Am J Cardiol. 2008 Jan 15;101(2):231-7. doi: 10.1016/j.amjcard.2007.07.066. Epub 2007 Dec 3.
PubMed 18178412Hauptman PJ, Goodlin SJ, Lopatin M, Costanzo MR, Fonarow GC, Yancy CW. Characteristics of patients hospitalized with acute decompensated heart failure who are referred for hospice care. Arch Intern Med. 2007 Oct 8;167(18):1990-7. doi: 10.1001/archinte.167.18.1990.
PubMed 17923600Fonarow GC, Peacock WF, Phillips CO, Givertz MM, Lopatin M; ADHERE Scientific Advisory Committee and Investigators. Admission B-type natriuretic peptide levels and in-hospital mortality in acute decompensated heart failure. J Am Coll Cardiol. 2007 May 15;49(19):1943-50. doi: 10.1016/j.jacc.2007.02.037. Epub 2007 Apr 30.
PubMed 17498579
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADHERE Core III - Acute Decompensated Heart Failure Registry
- ClinicalTrials.gov ID
- NCT00366639
- Acronym / sponsor ID
- CR005194
- Conditions
- Heart Failure, Congestive, Heart Decompensation
- Keywords
- Heart failure, congestive, Heart decompensation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24,118 participants (actual)
- Lead sponsor
- Scios, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2001
- Study completion
- Feb 2006 (actual)
- First posted
- 21 Aug 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 the ADHERE study is to develop a multi-center, observational, open-label registry of the management strategies of patients treated in the hospital for acute Heart Failure in the United States.
Detailed description
The objective is to compile a clinical database on the strategy for the medical management of patients hospitalized with acute Heart Failure (HF). Through the use of the information collected from acute care hospitals across the United States the following information may be coming out of this study: 1) Assist hospitals in evaluating and improving quality of care for patients with acute HF by tracking quality indicators and providing benchmark data reports; 2) Describe the demographic and clinical characteristics of patients who are hospitalized with acute HF; 3) Characterize the initial emergency department evaluation and subsequent inpatient management of patients hospitalized with acute HF; 4) Identify patient characteristics and medical care practices associated with improved health outcomes in those hospitalized with acute HF; 5) Characterize trends and changes over time in the management of acute HF; 6) Offer surveillance of adherence to practice guidelines as these emerge for the inpatient management of acute HF. Observational Study - No investigational drug administered
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Other: Acute Decompensated Heart Failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive adult patients admitted to an acute care hospital and treated actively for acute HF, where acute HF is defined clinically as a new onset with HF decompensation
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 years at the time of admission to the hospital
- Received or is eligible to receive a principal hospital discharge diagnosis of HF
- Decompensated HF is present as determined clinically by the patient care team
Key exclusion criteria (1 listed)
- HF is present as a co-morbid condition, but is not a principal focus of diagnosis or treatment during this hospitalization episode
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 |
|---|---|---|
| Acute Decompensated Heart FailureTreatment \& outcomes during hospital admission for Acute DHF | Other | 001 |
Primary outcome
Course of care in the Emergency Department (ED) and course of care in the inpatient hospital, use of diuretics (increase urine excretion) vasodilators (relax artey and veins) and inotropeic agents (increase the function of the heart) rate of death
Time frame: From admission to discharge from the hospital
1 secondary outcome
Data from patient demographics ( sex, age, gender, race)
Time frame: at patients admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2009.
- Derived from this study: PubMed 21095276Kociol RD, Hammill BG, Fonarow GC, Klaskala W, Mills RM, Hernandez AF, Curtis LH. Generalizability and longitudinal outcomes of a national heart failure clinical registry: Comparison of Acute Decompensated Heart Failure National Registry (ADHERE) and non-ADHERE Medicare beneficiaries. Am Heart J. 2010 Nov;160(5):885-92. doi: 10.1016/j.ahj.2010.07.020.
- Derived from this study: PubMed 18687247Maisel AS, Peacock WF, McMullin N, Jessie R, Fonarow GC, Wynne J, Mills RM. Timing of immunoreactive B-type natriuretic peptide levels and treatment delay in acute decompensated heart failure: an ADHERE (Acute Decompensated Heart Failure National Registry) analysis. J Am Coll Cardiol. 2008 Aug 12;52(7):534-40. doi: 10.1016/j.jacc.2008.05.010.
- Derived from this study: PubMed 18541822Kamath SA, Drazner MH, Wynne J, Fonarow GC, Yancy CW. Characteristics and outcomes in African American patients with decompensated heart failure. Arch Intern Med. 2008 Jun 9;168(11):1152-8. doi: 10.1001/archinte.168.11.1152.
- Derived from this study: PubMed 18480204Peacock WF 4th, De Marco T, Fonarow GC, Diercks D, Wynne J, Apple FS, Wu AH; ADHERE Investigators. Cardiac troponin and outcome in acute heart failure. N Engl J Med. 2008 May 15;358(20):2117-26. doi: 10.1056/NEJMoa0706824.
- Derived from this study: PubMed 18178412Fonarow GC, Peacock WF, Horwich TB, Phillips CO, Givertz MM, Lopatin M, Wynne J; ADHERE Scientific Advisory Committee and Investigators. Usefulness of B-type natriuretic peptide and cardiac troponin levels to predict in-hospital mortality from ADHERE. Am J Cardiol. 2008 Jan 15;101(2):231-7. doi: 10.1016/j.amjcard.2007.07.066. Epub 2007 Dec 3.
- Derived from this study: PubMed 17923600Hauptman PJ, Goodlin SJ, Lopatin M, Costanzo MR, Fonarow GC, Yancy CW. Characteristics of patients hospitalized with acute decompensated heart failure who are referred for hospice care. Arch Intern Med. 2007 Oct 8;167(18):1990-7. doi: 10.1001/archinte.167.18.1990.
- Derived from this study: PubMed 17498579Fonarow GC, Peacock WF, Phillips CO, Givertz MM, Lopatin M; ADHERE Scientific Advisory Committee and Investigators. Admission B-type natriuretic peptide levels and in-hospital mortality in acute decompensated heart failure. J Am Coll Cardiol. 2007 May 15;49(19):1943-50. doi: 10.1016/j.jacc.2007.02.037. Epub 2007 Apr 30.
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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.
Scios, Inc. Clinical Trial study director
Scios, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Congestive and Heart Decompensation, run by Scios, Inc..
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 3 inclusion and 1 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 2 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Course of care in the Emergency Department (ED) and course of care in the inpatient hospital, use of diuretics (increase urine excretion) vasodilators (relax artey and veins) and inotropeic agents (increase the function of the heart) rate of death (time frame: From admission to discharge from the hospital). 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 NCT00366639, which also lists 7 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 2 Nov 2009.