Heart Failure, CongestivePhase 4NCT00381030
Effects of Carvedilol on Health Outcomes in Heart Failure
A Phase 4 study testing carvedilol plus nurse management in people with Heart Failure, Congestive, run by Denver Health and Hospital Authority at 1 site in United States.
Trial summary
The purpose of our study was to determine if a strategy of starting a heart medication (Beta-blocker) before patients leave the hospital and then being seen by a nurse manager would reduce subsequent hospitalizations compared to usual care. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- carvedilol plus nurse management
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Mar 2005
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- primary hospitalization with heart failure and LVEF < 40%
- patient informed consent has been obtained
- absence of pulmonary congestion
- age > 18 years
Who cannot join
- End-stage renal or hepatic disease
- Acute myocardial infarction as primary diagnosis during index hospitalization
- Life-expectancy < 6-months
- Contraindication to beta blocker use
- Current beta-blocker therapy
- Planned bypass or valve surgery during index hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Medical Center
Denver, Colorado, 80204
About this study
Official title: Effects of Inpatient Initiation of Carvedilol and Nurse Management on Health Outcomes in Vulnerable Heart Failure Patients (ECHO Study): a Randomized Trial
The purpose of our study was to determine if a strategy of starting a heart medication (Beta-blocker) before patients leave the hospital and then being seen by a nurse manager would reduce subsequent hospitalizations compared to usual care.
Hypothesis: A nurse-directed heart failure management program with inpatient initiation of beta blockers will improve health outcomes in a vulnerable, predominantly Hispanic and African American population.
Read the detailed description
Heart failure is a leading cause of death and hospitalization in the US. Designing practical approaches to improving heart failure care is therefore a national health priority. One retrospective study suggested that patients taking beta-blockers while hospitalized for heart failure had a lower risk of rehospitalization at 6-months. One prospective study suggested that starting beta blockers among hospitalized heart failure patients is safe and improves compliance. However, improved outcomes of this approach have not been prospectively demonstrated.
Comparison: Inpatient initiation of the beta-blocker carvedilol coupled with outpatient follow-up with a nurse manager was compared to usual care by internists and cardiologists.
- Conditions
- Heart Failure, Congestive
- Being tested
- carvedilol plus nurse management
- Keywords
- beta-Adrenergic Blockers, Disease Management
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carvedilol plus nurse managementDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: heart failure hospitalizations, time to death or hospitalization
Secondary outcomes (3)
left ventricular ejection fraction and volume in systole and diastole
beta-blocker utilization/adherence
new york heart association functional class
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startOct 2002
- Study completionMar 2005
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Investigators
- Mori J Krantz, MD, Principal investigator, Denver Health Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381030
- Sponsor's protocol ID
- SKF105517/379
- Status last verified
- Sep 2006
- First submitted
- 25 Sep 2006
- Last updated
- 27 Sep 2006
- Results posted
- No
Publications
Krantz MJ, Havranek EP, Haynes DK, Smith I, Bucher-Bartelson B, Long CS. Inpatient initiation of beta-blockade plus nurse management in vulnerable heart failure patients: a randomized study. J Card Fail. 2008 May;14(4):303-9. doi: 10.1016/j.cardfail.2007.12.008.
PubMed 18474343
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inpatient Initiation of Carvedilol and Nurse Management on Health Outcomes in Vulnerable Heart Failure Patients (ECHO Study): a Randomized Trial
- ClinicalTrials.gov ID
- NCT00381030
- Acronym / sponsor ID
- SKF105517/379
- Conditions
- Heart Failure, Congestive
- Keywords
- beta-Adrenergic Blockers, Disease Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Study start
- Oct 2002
- Study completion
- Mar 2005
- First posted
- 27 Sep 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 our study was to determine if a strategy of starting a heart medication (Beta-blocker) before patients leave the hospital and then being seen by a nurse manager would reduce subsequent hospitalizations compared to usual care.
Hypothesis: A nurse-directed heart failure management program with inpatient initiation of beta blockers will improve health outcomes in a vulnerable, predominantly Hispanic and African American population.
Detailed description
Heart failure is a leading cause of death and hospitalization in the US. Designing practical approaches to improving heart failure care is therefore a national health priority. One retrospective study suggested that patients taking beta-blockers while hospitalized for heart failure had a lower risk of rehospitalization at 6-months. One prospective study suggested that starting beta blockers among hospitalized heart failure patients is safe and improves compliance. However, improved outcomes of this approach have not been prospectively demonstrated.
Comparison: Inpatient initiation of the beta-blocker carvedilol coupled with outpatient follow-up with a nurse manager was compared to usual care by internists and cardiologists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- primary hospitalization with heart failure and LVEF < 40%
- patient informed consent has been obtained
- absence of pulmonary congestion
- age > 18 years
Key exclusion criteria (6 listed)
- End-stage renal or hepatic disease
- Acute myocardial infarction as primary diagnosis during index hospitalization
- Life-expectancy < 6-months
- Contraindication to beta blocker use
- Current beta-blocker therapy
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 |
|---|---|---|
| carvedilol plus nurse management | Drug | – |
Primary outcome
Primary outcome: heart failure hospitalizations, time to death or hospitalization
3 secondary outcomes
left ventricular ejection fraction and volume in systole and diastole
beta-blocker utilization/adherence
new york heart association functional class
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 27 Sep 2006.
- Derived from this study: PubMed 18474343Krantz MJ, Havranek EP, Haynes DK, Smith I, Bucher-Bartelson B, Long CS. Inpatient initiation of beta-blockade plus nurse management in vulnerable heart failure patients: a randomized study. J Card Fail. 2008 May;14(4):303-9. doi: 10.1016/j.cardfail.2007.12.008.
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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.
Mori J Krantz, MD principal investigator
Denver Health Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing carvedilol plus nurse management in people with Heart Failure, Congestive, run by Denver Health and Hospital Authority 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 4 inclusion and 6 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 27 Sep 2006. 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.
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?
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?
Primary outcome: heart failure hospitalizations, time to death or hospitalization. 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 NCT00381030, 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 27 Sep 2006.