DiseaseCOPDNCT02340702
Chronic Obstructive Pulmonary Disease (COPD) in Patients Hospitalized for Acute Decompensated Heart Failure.
An observational study of Disease, run by Mayo Clinic.
Trial summary
The presence of chronic obstructive pulmonary disease (COPD) would confer increased in-hospital mortality and length of hospital stay in patients with acute decompensated heart failure Assess the (1) prevalence of COPD in patients who are hospitalized for acute decompensated heart failure and (2) the association… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disease
- What is being tested?
- COPD
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Aug 2017
- How long will I take part?
- 5 Weeks
- 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: Patients hospitalized for acute decompensated heart Failure
Who may be able to join
- Heart failure
Who cannot join
- Ambulatory patients
About this study
Official title: COPD in Patients Hospitalized for Acute Decompensated Heart Failure.
The presence of chronic obstructive pulmonary disease (COPD) would confer increased in-hospital mortality and length of hospital stay in patients with acute decompensated heart failure Assess the (1) prevalence of COPD in patients who are hospitalized for acute decompensated heart failure and (2) the association between COPD and in-hospital mortality or length of stay in this cohort.
Read the detailed description
Background:
The prevalence of mild to moderate COPD is ~5%-10% with one-year mortality around 3% while heart failure affects is1%-3% with one year mortality 5-7% in the community. The mortality of COPD and heart failure dramatically increase following hospitalization.
Heart failure and COPD are independent predictors of increased morbidity and mortality. COPD and heart failure frequently co-exist in an individual patient through the shared risk factors. The prevalence of COPD in heart failure patient-population and vice verse varies widely according to patient-selection and age of the population. Estimates suggest that COPD is present in 10-40% of the patients with heart failure. Conversely, unrecognized heart failure is identified in approximately 20% of the patient with COPD. The impact of COPD on clinical outcome in patients with acute decompensated heart failure is unclear.
Methods:
This is an observational cohort study. Per national registry, acute heart failure is defined as either new onset heart failure or decompensation of chronic established heart failure with symptoms sufficient to warrant hospitalization.
The data related to the following variables would be collected:
age, gender, severity of heart failure (mild, moderate, and severe prior to admission), presence of dyspnea, peripheral edema, crackles, systolic and diastolic blood pressure (on admission and on discharge), heart rate (on admission and on discharge), oxygen saturation (on admission and discharge), blood urea nitrogen (on admission and discharge), serum creatinine (on admission and discharge), serum sodium (on admission and discharge), hemoglobin (on admission and discharge), red cell distribution width (on admission and discharge), electrocardiographic intervals (on admission and discharge), comorbidities (coronary artery disease, chronic kidney disease, atrial fibrillation, diabetes, hypertension, dyslipidemia, peripheral artery disease, COPD/asthma, left ventricular ejection fraction >40%. Medication use: angiotensin converting enzyme inhibitors, angiotensin receptor blockers, aspirin, metoprolol tartrate, metoprolol succinate, carvedilol, atenolol, amlodipine, Cardizem, clopidogrel, digoxin, diuretics, statins, nitrates, warfarin, non-steroidal anti-inflammatory drugs, hydralazine.
End-points:
- All cause in-hospital death and 2) length of hospital stay between heart failure patients with COPD and those with no COPD.
- Conditions
- Disease
- Being tested
- COPD
- Keywords
- COPD and heart failure
- Medical subject headings
- Disease, Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPDOther
Also called chronic obstructive pulmonary disease
COPD as diagnosed clinically or based on pulmonary function test showing post-bronchodilator forced expiratory volume in one second to forced vital capacity ratio of <0.7.
| Study group | Role | What they receive |
|---|---|---|
| Patient with COPD and those without COPD | The participants of acute decompensated heart failure national registry would be stratified in to two group: those with COPD and those without COPD, to determine prognostic implication of COPD in participants with acute decompensated heart failure Receives: Other: COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Participants would be followed for the duration of hospital stay
Measured: Average of 5-weeks
Secondary outcomes (1)
Length of hospital stay
Measured: Average of 5-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: Unable to abstract pulmonary function and some other data from medical records.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 0 participants (actual)
- Target duration
- 5 Weeks
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Yousufuddin, M.D, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340702
- Sponsor's protocol ID
- 14-006196
- Acronym
- COPD
- Status last verified
- Feb 2020
- First submitted
- 7 Jan 2015
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPD in Patients Hospitalized for Acute Decompensated Heart Failure.
- ClinicalTrials.gov ID
- NCT02340702
- Acronym / sponsor ID
- COPD / 14-006196
- Conditions
- Disease
- Keywords
- COPD and heart failure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to abstract pulmonary function and some other data from medical records.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 19 Jan 2015 (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 presence of chronic obstructive pulmonary disease (COPD) would confer increased in-hospital mortality and length of hospital stay in patients with acute decompensated heart failure Assess the (1) prevalence of COPD in patients who are hospitalized for acute decompensated heart failure and (2) the association between COPD and in-hospital mortality or length of stay in this cohort.
Detailed description
Background:
The prevalence of mild to moderate COPD is ~5%-10% with one-year mortality around 3% while heart failure affects is1%-3% with one year mortality 5-7% in the community. The mortality of COPD and heart failure dramatically increase following hospitalization.
Heart failure and COPD are independent predictors of increased morbidity and mortality. COPD and heart failure frequently co-exist in an individual patient through the shared risk factors. The prevalence of COPD in heart failure patient-population and vice verse varies widely according to patient-selection and age of the population. Estimates suggest that COPD is present in 10-40% of the patients with heart failure. Conversely, unrecognized heart failure is identified in approximately 20% of the patient with COPD. The impact of COPD on clinical outcome in patients with acute decompensated heart failure is unclear.
Methods:
This is an observational cohort study. Per national registry, acute heart failure is defined as either new onset heart failure or decompensation of chronic established heart failure with symptoms sufficient to warrant hospitalization.
The data related to the following variables would be collected:
age, gender, severity of heart failure (mild, moderate, and severe prior to admission), presence of dyspnea, peripheral edema, crackles, systolic and diastolic blood pressure (on admission and on discharge), heart rate (on admission and on discharge), oxygen saturation (on admission and discharge), blood urea nitrogen (on admission and discharge), serum creatinine (on admission and discharge), serum sodium (on admission and discharge), hemoglobin (on admission and discharge), red cell distribution width (on admission and discharge), electrocardiographic intervals (on admission and discharge), comorbidities (coronary artery disease, chronic kidney disease, atrial fibrillation, diabetes, hypertension, dyslipidemia, peripheral artery disease, COPD/asthma, left ventricular ejection fraction >40%. Medication use: angiotensin converting enzyme inhibitors, angiotensin receptor blockers, aspirin, metoprolol tartrate, metoprolol succinate, carvedilol, atenolol, amlodipine, Cardizem, clopidogrel, digoxin, diuretics, statins, nitrates, warfarin, non-steroidal anti-inflammatory drugs, hydralazine.
End-points:
- All cause in-hospital death and 2) length of hospital stay between heart failure patients with COPD and those with no COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with COPD and those without COPD | – | Other: COPDThe participants of acute decompensated heart failure national registry would be stratified in to two group: those with COPD and those without COPD, to determine prognostic implication of COPD in participants with 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
- Patients hospitalized for acute decompensated heart Failure
Key inclusion criteria (1 listed)
- Heart failure
Key exclusion criteria (1 listed)
- Ambulatory patients
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 |
|---|---|---|
| COPDAlso: chronic obstructive pulmonary diseaseCOPD as diagnosed clinically or based on pulmonary function test showing post-bronchodilator forced expiratory volume in one second to forced vital capacity ratio of <0.7. | Other | Patient with COPD and those without COPD |
Primary outcome
In-hospital mortality
Time frame: Average of 5-weeks
Participants would be followed for the duration of hospital stay
1 secondary outcome
Length of hospital stay
Time frame: Average of 5-weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Mayo Clinic Clinical TrialsLink 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Disease, run by Mayo Clinic.
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 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: withdrawn, as of the sponsor's last update on 11 Mar 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
In-hospital mortality (time frame: Average of 5-weeks). 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 Mar 2020.