Acute on Chronic Heart FailureHEARTNCT01726985
Model for Heart Failure ExAcerbation Reduction Trial
An observational study of Acute on Chronic Heart Failure, run by Cleveland Clinic Florida at 1 site in United States.
Trial summary
Heart failure is the leading cause of hospitalizations and readmissions in the United States and is a tremendous economic strain on our healthcare system. There is currently, based on national averages, a 30% readmission rate and 10% mortality rate within 3 months of being hospitalized for heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute on Chronic Heart Failure
- What is being tested?
- Parameter Based Clinical Disposition
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Oct 2014
- 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 patients aged 18 and over hospitalized at Cleveland Clinic Florida with diagnosis of CHF.
Who may be able to join
- Must have either Acute on Chronic Heart Failure or Chronic Heart Failure regardless of presenting/primary complaint
- To fulfill CHF Dx, MUST have 2+ of the following:
- Clinical: Dyspnea, orthopnea, PND, edema, S3, rales, improve w diuretics
- Radiographic: Pulm venous congestion, pleural effs, cardiomegaly
- Lab: NT pro BNP > 1000
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Model for Heart Failure ExAcerbation Reduction Trial - "Model HEART"
Heart failure is the leading cause of hospitalizations and readmissions in the United States and is a tremendous economic strain on our healthcare system. There is currently, based on national averages, a 30% readmission rate and 10% mortality rate within 3 months of being hospitalized for heart failure. Retrospective studies have shown benefit to using biomarkers such as BNP to guide inpatient heart failure management. Our own CCF retrospective study showed that decreasing NT-ProBNP by 23%, making patients fluid negative by more than 1.3L, and discharging patients with serum sodium above 135 reduces readmission rates significantly. The purpose of this study is to prospectively use the above mentioned goals in the treatment of heart failure in order to reduce heart failure readmission and mortality rates.
Read the detailed description
All HF patients admitted to CCF will receive a short consent form. The study will enroll patients for one year. Physicians will initiate / titrate medications and obtain consults as usual but are highly encourage to keep patients in the hospital until at least 2 of the 3 (above mentioned) criteria are met. Physicians will receive a copy of consent forms, educational bulletins, and discharge forms (as described in the Physician Education document which is attached to this application). Log-rank test will be used to compare groups. Chi-Square will be used to compare prospective patients with retrospective controls (obtained in 2010).
- Conditions
- Acute on Chronic Heart Failure
- Being tested
- Parameter Based Clinical Disposition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parameter Based Clinical DispositionOther
Parameter Based Clinical Disposition'
Physicians will initiate / titrate medications and obtain consults as usual but are highly encourage to keep patients in the hospital until at least 2 of the following 3 criteria are met:
- NT-ProBNP reduction of > 23% from peak value during admission
- Fluid Reduction of > 1.3L (orders for I/O q8h required)
- Serum Sodium of > 135 mmol/L the day of planned discharge
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized with CHF | Patients hospitalized with CHF Parameter Based Clinical Disposition Receives: Other: Parameter Based Clinical Disposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Readmission for CHF
Measured: up to 1 year
Secondary outcomes (1)
CHF Mortality
Measured: 90 days, 180 days, 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute on Chronic 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
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlow Hernandez, Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726985
- Sponsor's protocol ID
- 121368
- Acronym
- HEART
- Status last verified
- Nov 2012
- First submitted
- 12 Nov 2012
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model for Heart Failure ExAcerbation Reduction Trial - "Model HEART"
- ClinicalTrials.gov ID
- NCT01726985
- Acronym / sponsor ID
- HEART / 121368
- Conditions
- Acute on Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Cleveland Clinic FloridaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 Nov 2012 (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.
Heart failure is the leading cause of hospitalizations and readmissions in the United States and is a tremendous economic strain on our healthcare system. There is currently, based on national averages, a 30% readmission rate and 10% mortality rate within 3 months of being hospitalized for heart failure. Retrospective studies have shown benefit to using biomarkers such as BNP to guide inpatient heart failure management. Our own CCF retrospective study showed that decreasing NT-ProBNP by 23%, making patients fluid negative by more than 1.3L, and discharging patients with serum sodium above 135 reduces readmission rates significantly. The purpose of this study is to prospectively use the above mentioned goals in the treatment of heart failure in order to reduce heart failure readmission and mortality rates.
Detailed description
All HF patients admitted to CCF will receive a short consent form. The study will enroll patients for one year. Physicians will initiate / titrate medications and obtain consults as usual but are highly encourage to keep patients in the hospital until at least 2 of the 3 (above mentioned) criteria are met. Physicians will receive a copy of consent forms, educational bulletins, and discharge forms (as described in the Physician Education document which is attached to this application). Log-rank test will be used to compare groups. Chi-Square will be used to compare prospective patients with retrospective controls (obtained in 2010).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized with CHF | – | Other: Parameter Based Clinical DispositionPatients hospitalized with CHF Parameter Based Clinical Disposition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged 18 and over hospitalized at Cleveland Clinic Florida with diagnosis of CHF.
Key inclusion criteria (5 listed)
- Must have either Acute on Chronic Heart Failure or Chronic Heart Failure regardless of presenting/primary complaint
- Clinical: Dyspnea, orthopnea, PND, edema, S3, rales, improve w diuretics
- Radiographic: Pulm venous congestion, pleural effs, cardiomegaly
- Lab: NT pro BNP > 1000
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Parameter Based Clinical DispositionParameter Based Clinical Disposition' Physicians will initiate / titrate medications and obtain consults as usual but are highly encourage to keep patients in the hospital until at least 2 of the following 3 criteria are met: * NT-ProBNP reduction of > 23% from peak value during admission * Fluid Reduction of > 1.3L (orders for I/O q8h required) * Serum Sodium of > 135 mmol/L the day of planned discharge | Other | Patients hospitalized with CHF |
Primary outcome
Hospital Readmission for CHF
Time frame: up to 1 year
1 secondary outcome
CHF Mortality
Time frame: 90 days, 180 days, 1 yr
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 11 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Marlow Hernandez principal investigator
Cleveland Clinic Florida
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 Acute on Chronic Heart Failure, run by Cleveland Clinic Florida 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 5 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 11 Apr 2017. 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?
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?
Hospital Readmission for CHF (time frame: up to 1 year). 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 11 Apr 2017.