UAB Lung Health Center
Birmingham, Alabama, 35294, United States
NCT Number: NCT03110614
This is a prospective study to determine the relationships between pauci-inflammatory exacerbations and diastolic dysfunction, and their implications in hospitalized patients with acute exacerbations of COPD. To assess changes within subjects from stable to acute phase, a number of comparisons will be made in subjects enrolled during acute exacerbation with similar measurements made in the stable phase after recovery from exacerbation after at least 35 days from index hospitalization or prior exacerbation.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Birmingham, Alabama, 35294, United States
Informed consent will be obtained within the first 24 hours of admission. Written informed consent will be obtained from the subject or a legally authorized representative.
Visit Schedule:
V1 (Day 0 of Hospitalization):
Demographic and clinical information including age, gender, race, smoking status, number of pack-years of smoking, body mass index, waist hip circumference, co-morbidities such as diabetes mellitus, hypertension, hyperlipidemia, depression, coronary artery disease and chronic kidney disease, history of previous exacerbations, detailed occupation history, and detailed medication history with emphasis on cardiovascular medications will be conducted. The COPD Assessment Test (CAT) questionnaire and the modified Medical Research Council (mMRC) assessment will be administered. Bed-side spirometry will be conducted. Blood will be drawn for lab tests (about 30 mL or 6 teaspoons). Electrocardiography (ECG), lung ultrasound and echocardiography will be performed.
V2 (hospital discharge day or day 3 of hospitalization whichever is earlier):
Blood will be drawn for lab test- CRP only ( about 5mL or 1 teaspoon). Participant will be scheduled for a follow-up visit at the Lung Health Center.
V3 (Day 35- Follow-up visit at Lung Health Center):
The COPD Assessment Test (CAT) questionnaire and the modified Medical Research Council (mMRC) assessment will be administered. The following Pulmonary Function Tests will be conducted: Spirometry, lung Volumes and DLCO. Six-minute walk test will be conducted. Blood will be drawn for lab tests (about 30 mL or 6 teaspoons). Electrocardiography, lung ultrasound and echocardiography will be performed.
Telephone follow-up: The participant will be called once every 6 months for one year, to ask about COPD symptoms.
Description of procedures:
Questionnaires:
Dyspnea: will be assessed using the modified Medical Research Council (mMRC). The mMRC scale is a simple grading system to assess a patient's level of dyspnea, ranging from 0 for minimal to 4 for severe dyspnea.
COPD related Quality of life: will be assessed using the COPD Assessment Test (CAT) The CAT questionnaire consists of 8 simple questions which are graded from 0 to 5. The total score can range from 0 to 40. A change of 2 units is considered clinically significant (minimal clinically important difference).
Pulmonary Function Tests (PFTs):
Bedside spirometry will be performed using a handheld spirometer, and the following parameters will be recorded: forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio , forced expiratory flow in the middle 25 to 75% of flow (FEF25-75%), inspiratory capacity (IC), and peak expiratory flow rate (PEFR). A subsequent full set of pulmonary function tests will be obtained in the recovery phase on day 35 using a hand held spirometer and body plethysmography. This will include FEV1 , FVC, FEV1/FVC, FEF25-75%, IC, PEFR, total lung capacity (TLC), residual volume (RV), and diffusing capacity of carbon monoxide (DLCO).
Blood: will be collected to measure markers of systemic inflammation such as C-reactive protein (CRP), fibrinogen, IL-6 and TNF-alpha, and measures of cardiac function such as troponin and brain natriuretic peptide (BNP).
Six-Minute Walk Test: The 6 minute walk test measures the mean distance walked on a 100 meter straight, hard-surfaced coarse in 6 minutes while being continuously monitored by the study coordinator.
Ultrasound of lungs: B mode ultrasonography will be used to assess pulmonary congestion.
Echocardiography: Parameters of systolic and diastolic function will be assessed using 2D and Doppler echocardiography using standard echo windows.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at baseline (at time of hospitalization)
We will estimate the frequency of diastolic dysfunction on echocardiogram in exacerbations that are pauci-inflammatory vs. inflammatory at the time of enrollment.
Time frame: 1 year post hospitalization
Number of exacerbations in the year following index admission between those with and without diastolic dysfunction.
Time frame: at or after 35 days post hospitalization
The CAT questionnaire consists of 8 simple questions which are graded from 0 to 5. The total score can range from 0 to 40. This measure will be compared between those with and without diastolic dysfunction at the follow-up visit.
Time frame: at or after 35 days post hospitalization
Dyspnea will be assessed using the modified Medical Research Council (mMRC) scale, ranging from 0 for minimal to 4 for severe dyspnea. We will also assess dyspnea using the more sensitive San Diego Shortness Of Breath Questionnaire (SOBQ), which rates dyspnea associated with activities of daily living (range 0 to 120). These measures will be compared between those with and without diastolic dysfunction at the follow-up visit.
Time frame: at or after 35 days post hospitalization
Dyspnea will be assessed using the San Diego Shortness Of Breath Questionnaire (SOBQ), which rates dyspnea associated with activities of daily living (range 0 to 120). These measures will be compared between those with and without diastolic dysfunction at the follow-up visit.
Time frame: at or after 35 days post hospitalization.
This measure of exercise capacity will be compared between those with and without diastolic dysfunction at the follow-up visit.
University of Alabama at Birmingham
Other
Diastolic Dysfunction and Pauci-inflammatory Acute Exacerbations of Chronic Obstructive Pulmonary Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05984823
Chronic Disease, Chronic Obstructive Pulmonary Disease
Leicester, Leicestershire, United Kingdom
View Trial DetailsNCT05572333
COPD, Chronic Disease
Frankfurt, Germany
View Trial DetailsNCT03641235
Chronic Disease, Chronic Obstructive Pulmonary Disease
Bordeaux, France
View Trial DetailsNCT05984680
Chronic Disease, Chronic Obstructive Pulmonary Disease
Winston-Salem, North Carolina, United States
View Trial Details