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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02340702
Other study ID # 14-006196
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date August 2014
Est. completion date August 2017

Study information

Verified date February 2020
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 between COPD and in-hospital mortality or length of stay in this cohort.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Heart failure

Exclusion Criteria:

- Ambulatory patients

Study Design


Related Conditions & MeSH terms


Intervention

Other:
COPD
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Outcome

Type Measure Description Time frame Safety issue
Primary In-hospital mortality Participants would be followed for the duration of hospital stay Average of 5-weeks
Secondary Length of hospital stay Average of 5-weeks
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