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Trial record 17 of 54 for:    COPD OR COPD OR chronic obstructive pulmonary disease OR chronic bronchitis OR emphysema | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Diastolic Dysfunction and Pauci-inflammatory Acute Exacerbations of COPD

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ClinicalTrials.gov Identifier: NCT03110614
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Surya P Bhatt, University of Alabama at Birmingham

Brief Summary:
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.

Condition or disease
Chronic Obstructive Pulmonary Disease Diastolic Dysfunction

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 188 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diastolic Dysfunction and Pauci-inflammatory Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Actual Study Start Date : November 25, 2013
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021



Primary Outcome Measures :
  1. Difference in the proportion of diastolic dysfunction in pauci-inflammatory exacerbations vs. inflammatory exacerbations [ 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.


Secondary Outcome Measures :
  1. Rate of exacerbations [ Time Frame: 1 year post hospitalization ]
    Number of exacerbations in the year following index admission between those with and without diastolic dysfunction.

  2. Differences in COPD Assessment Test (CAT) in 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.

  3. Differences in dyspnea using the modified Medical Research Council (mMRC) scale [ 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.

  4. Differences in dyspnea using the San Diego Shortness of Breath Questionnaire (SOBQ) [ 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.

  5. Differences in 6-minute walk distance [ 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.


Biospecimen Retention:   Samples Without DNA
Blood and Exhaled breath condensate for inflammatory markers.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients with acute exacerbations of COPD will be approached for participation in the study.
Criteria

Inclusion Criteria:

  • Patients age 18 and older
  • Patients admitted to the general medicine or pulmonary floors, or the medical intensive care unit with a primary diagnosis of acute exacerbation of COPD will be eligible for the study.

Exclusion Criteria:

  • Patients with a secondary diagnosis of congestive heart failure and other respiratory conditions that the investigator's deem could confound the diagnosis including but not limited to pneumonia, bronchiectasis and lung cancer will be excluded.
  • Pregnant or breastfeeding women will be excluded.
  • Patients with conditions that preclude an adequate echocardiogram such as hemodynamically significant arrhythmias will also be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110614


Contacts
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Contact: Surya P Bhatt, MD (205) 934-5555 sbhatt@uabmc.edu

Locations
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United States, Alabama
UAB Lung Health Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Mark T Dransfield, MD    205-934-5555      
Principal Investigator: Mark T Dransfield, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Surya P Bhatt, MD University of Alabama at Birmingham

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Responsible Party: Surya P Bhatt, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03110614     History of Changes
Other Study ID Numbers: F121120003
K23HL133438-01 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Surya P Bhatt, University of Alabama at Birmingham:
COPD
acute
exacerbation
lung ultrasound
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases