Chronic Obstructive Pulmonary DiseaseNCT03110614
Diastolic Dysfunction and Pauci-inflammatory Acute Exacerbations of COPD
An observational study of Chronic Obstructive Pulmonary Disease and Diastolic Dysfunction, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Diastolic Dysfunction
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2013to 30 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with acute exacerbations of COPD will be approached for participation in the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diastolic Dysfunction and Pauci-inflammatory Acute Exacerbations of Chronic Obstructive Pulmonary Disease
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.
Read the detailed description
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.
- Keywords
- COPD, acute, exacerbation, lung ultrasound
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the proportion of diastolic dysfunction in pauci-inflammatory exacerbations vs. inflammatory exacerbations
We will estimate the frequency of diastolic dysfunction on echocardiogram in exacerbations that are pauci-inflammatory vs. inflammatory at the time of enrollment.
Measured: at baseline (at time of hospitalization)
Secondary outcomes (5)
Rate of exacerbations
Number of exacerbations in the year following index admission between those with and without diastolic dysfunction.
Measured: 1 year post hospitalization
Differences in COPD Assessment Test (CAT) in those with and without diastolic dysfunction
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.
Measured: at or after 35 days post hospitalization
Differences in dyspnea using the modified Medical Research Council (mMRC) scale
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.
Measured: at or after 35 days post hospitalization
Differences in dyspnea using the San Diego Shortness of Breath Questionnaire (SOBQ)
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.
Measured: at or after 35 days post hospitalization
Differences in 6-minute walk distance
This measure of exercise capacity will be compared between those with and without diastolic dysfunction at the follow-up visit.
Measured: at or after 35 days post hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start25 Nov 2013
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Surya P Bhatt, University of Alabama at Birmingham
- Investigators
- Surya P Bhatt, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110614
- Sponsor's protocol ID
- F121120003
- Other IDs
- K23HL133438-01
- Status last verified
- Oct 2021
- First submitted
- 15 Mar 2017
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diastolic Dysfunction and Pauci-inflammatory Acute Exacerbations of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03110614
- Acronym / sponsor ID
- F121120003
- Keywords
- COPD, acute, exacerbation, lung ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 25 Nov 2013 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with acute exacerbations of COPD will be approached for participation in the study.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Rate of exacerbations
Time frame: 1 year post hospitalization
Differences in COPD Assessment Test (CAT) in those with and without diastolic dysfunction
Time frame: at or after 35 days post hospitalization
Differences in dyspnea using the modified Medical Research Council (mMRC) scale
Time frame: at or after 35 days post hospitalization
Differences in dyspnea using the San Diego Shortness of Breath Questionnaire (SOBQ)
Time frame: at or after 35 days post hospitalization
Differences in 6-minute walk distance
Time frame: at or after 35 days post hospitalization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surya P Bhatt, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Diastolic Dysfunction, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the proportion of diastolic dysfunction in pauci-inflammatory exacerbations vs. inflammatory exacerbations (time frame: at baseline (at time of hospitalization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.