Clinical trial NCT02340702: Chronic Obstructive Pulmonary Disease (COPD) in Patients Hospitalized for Acute Decompensated Heart Failure.
Official title: COPD in Patients Hospitalized for Acute Decompensated Heart Failure.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Disease
Keywords: COPD and heart failure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for acute decompensated heart Failure

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.

Eligibility criteria: Inclusion Criteria:

* Heart failure

Exclusion Criteria:

* Ambulatory patients

Primary outcomes:
measure: In-hospital mortality
timeFrame: Average of 5-weeks
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Average of 5-weeks
Other outcomes:
Locations:
Study officials:
References: