Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-02-28 @ 2:30 PM
Study NCT ID:
NCT02340702
Status:
WITHDRAWN
Last Update Posted:
2020-03-11
First Post:
2015-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Obstructive Pulmonary Disease (COPD) in Patients Hospitalized for Acute Decompensated Heart Failure.
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
COPD in Patients Hospitalized for Acute Decompensated Heart Failure.
Status:
WITHDRAWN
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to abstract pulmonary function and some other data from medical records.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPD
Brief 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 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:
1\) All cause in-hospital death and 2) length of hospital stay between heart failure patients with COPD and those with no COPD.
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:
1\) All cause in-hospital death and 2) length of hospital stay between heart failure patients with COPD and those with no COPD.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: