COPDNCT05366400
Relationship Between Right Atrial Volume Index, Functional Capacity and Inflammatory Biomarkers in Patients With COPD.
An observational study of COPD and Right Heart Failure, run by Damanhour University at 1 site in Egypt.
Trial summary
Right ventricular (RV) dysfunction is associated with increased morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD). Assessment of RV function by echocardiography is challenging. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COPD, Right Heart Failure
- What is being tested?
- ECHO
- How many people
- 151 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jan 2022to 1 Sep 2022
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: All COPD patients participate in this study, were diagnosed on clinical based data and confirmed by spirometry findings according to the diagnostic criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines. This study was carried out on COPD patients who were selected from patients visited Chest Department or attending Chest outpatient clinic of Tanta University Hospitals, Echocardiography was done in the Cardiology Department.
Who may be able to join
None listed.
Who cannot join
- Patients with diagnosis of other respiratory diseases (e.g. asthma, interstitial pulmonary fibrosis , tuberculosis or lung cancer ), ischemic heart disease, congestive heart failure, valvular heart disease and congenital heart diseases, were excluded. Other chronic diseases, such as kidney or liver failure and cancer were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Relationship Between Right Atrial Volume Index, Functional Capacity and Inflammatory Biomarkers in Patients With Chronic Obstructive Lung Disease and Right Heart Affection.
Right ventricular (RV) dysfunction is associated with increased morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD). Assessment of RV function by echocardiography is challenging. Easy visualization of the right atrium (RA) by echocardiography , allows quantitative, highly reproducible assessment of RA volume. The aim of the present study is to evaluate the relationship between the right atrial volume index (RAVI) and functional capacity in patients with COPD , quantified by the COPD assessment test (CAT) questionnaire as an early predictor of right heart affection.
Read the detailed description
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
- All participants agreed to take part in this clinical study and provide informed consent.
- Patients who were selected from patients visited Chest Department or attending Chest outpatient clinic of Tanta University Hospitals, Echocardiography was done in the Cardiology Department..
- Complete physical and laboratory assessment will be done for all patients.
- Serum samples will be collected for measuring the biomarkers.
- 150 patients with COPD and preserved left ventricular systolic function, ejection fraction (LVEF) > 55% will enrolled. The RA volume calculated by biplane area length method using four chamber view twice and indexed to body surface area (RAVI). Assessment of RV systolic function was done using tricuspid annular plane systolic excursion (TAPSE), and peak systolic velocity (S'tri) using tissue Doppler imaging at the tricuspid annulus. The functional capacity was assessed by the COPD assessment test (CAT) questionnaire.
- For each participant, blood samples were obtained and levels of adiponectin, IL-1B, high-sensitivity C-reactive protein and Neopterin will be determined in all studied subjects.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
- Conditions
- COPD, Right Heart Failure
- Being tested
- ECHO
- Keywords
- Chronic obstructive lung disease., Right atrial volume index., Functional capacity., Adiponectin., Hs-CRP., IL1b., Neoptrin.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECHODiagnostic test
Conventional routine tests and ECHO will be assessed. Biomarkers will be measured using ELISA The functional capacity was assessed by the COPD assessment test (CAT) questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Group I (CAT) ≥ 10 | CAT is an eight-item questionnaire with a six-item Likert scale ranging from 0 to 5. The score ranges from zero (completely asymptomatic) to 40 (extremely symptomatic). A CAT score ≥10 is associated with a significantly impaired health status. Receives: Diagnostic Test: ECHO | |
| Group II (CAT) < 10 | CAT is an eight-item questionnaire with a six-item Likert scale ranging from 0 to 5. The score ranges from zero (completely asymptomatic) to 40 (extremely symptomatic). A CAT score < 10 is associated with a significantly preserved health status. Receives: Diagnostic Test: ECHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
RAVI (ml/m2)
Right atrial volume index
Measured: 3 month
Adiponectin (mg/L)
Serum Level
Measured: 3 month
Neopterin (nmol/L)
Serum Level
Measured: 3 month
IL-1beta (pg/mL)
Serum Level
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start19 Jan 2022
- Primary completion30 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Ass. Prof., Principal investigator, Damanhour UniversityLamiaa Khedr, Ass. Prof., Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366400
- Sponsor's protocol ID
- RAVI in COPD patients
- Status last verified
- May 2023
- First submitted
- 4 May 2022
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thierer J, Acosta A, Vainstein N, Sultan M, Francesia A, Marino J, Prado AH, Guglielmone R, Trivi M, Boero L, Brites F, Anker S. Relation of left ventricular ejection fraction and functional capacity with metabolism and inflammation in chronic heart failure with reduced ejection fraction (from the MIMICA Study). Am J Cardiol. 2010 Apr 1;105(7):977-83. doi: 10.1016/j.amjcard.2009.11.017. Epub 2010 Feb 13.
PubMed 20346316de Groote P, Millaire A, Foucher-Hossein C, Nugue O, Marchandise X, Ducloux G, Lablanche JM. Right ventricular ejection fraction is an independent predictor of survival in patients with moderate heart failure. J Am Coll Cardiol. 1998 Oct;32(4):948-54. doi: 10.1016/s0735-1097(98)00337-4.
PubMed 9768716
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Right Atrial Volume Index, Functional Capacity and Inflammatory Biomarkers in Patients With Chronic Obstructive Lung Disease and Right Heart Affection.
- ClinicalTrials.gov ID
- NCT05366400
- Acronym / sponsor ID
- RAVI in COPD patients
- Conditions
- COPD, Right Heart Failure
- Keywords
- Chronic obstructive lung disease., Right atrial volume index., Functional capacity., Adiponectin., Hs-CRP., IL1b., Neoptrin.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 9 May 2022 (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.
Right ventricular (RV) dysfunction is associated with increased morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD). Assessment of RV function by echocardiography is challenging. Easy visualization of the right atrium (RA) by echocardiography , allows quantitative, highly reproducible assessment of RA volume. The aim of the present study is to evaluate the relationship between the right atrial volume index (RAVI) and functional capacity in patients with COPD , quantified by the COPD assessment test (CAT) questionnaire as an early predictor of right heart affection.
Detailed description
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
- All participants agreed to take part in this clinical study and provide informed consent.
- Patients who were selected from patients visited Chest Department or attending Chest outpatient clinic of Tanta University Hospitals, Echocardiography was done in the Cardiology Department..
- Complete physical and laboratory assessment will be done for all patients.
- Serum samples will be collected for measuring the biomarkers.
- 150 patients with COPD and preserved left ventricular systolic function, ejection fraction (LVEF) > 55% will enrolled. The RA volume calculated by biplane area length method using four chamber view twice and indexed to body surface area (RAVI). Assessment of RV systolic function was done using tricuspid annular plane systolic excursion (TAPSE), and peak systolic velocity (S'tri) using tissue Doppler imaging at the tricuspid annulus. The functional capacity was assessed by the COPD assessment test (CAT) questionnaire.
- For each participant, blood samples were obtained and levels of adiponectin, IL-1B, high-sensitivity C-reactive protein and Neopterin will be determined in all studied subjects.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (CAT) ≥ 10 | – | Diagnostic Test: ECHOCAT is an eight-item questionnaire with a six-item Likert scale ranging from 0 to 5. The score ranges from zero (completely asymptomatic) to 40 (extremely symptomatic). A CAT score ≥10 is associated with a significantly impaired health status. |
| Group II (CAT) < 10 | – | Diagnostic Test: ECHOCAT is an eight-item questionnaire with a six-item Likert scale ranging from 0 to 5. The score ranges from zero (completely asymptomatic) to 40 (extremely symptomatic). A CAT score < 10 is associated with a significantly preserved health status. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All COPD patients participate in this study, were diagnosed on clinical based data and confirmed by spirometry findings according to the diagnostic criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines. This study was carried out on COPD patients who were selected from patients visited Chest Department or attending Chest outpatient clinic of Tanta University Hospitals, Echocardiography was done in the Cardiology Department.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients with diagnosis of other respiratory diseases (e.g. asthma, interstitial pulmonary fibrosis , tuberculosis or lung cancer ), ischemic heart disease, congestive heart failure, valvular heart disease and congenital heart diseases, were excluded. Other chronic diseases, such as kidney or liver failure and cancer were also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECHOConventional routine tests and ECHO will be assessed. Biomarkers will be measured using ELISA The functional capacity was assessed by the COPD assessment test (CAT) questionnaire. | Diagnostic test | Group I (CAT) ≥ 10, Group II (CAT) < 10 |
Primary outcome
RAVI (ml/m2)
Time frame: 3 month
Right atrial volume index
Adiponectin (mg/L)
Time frame: 3 month
Serum Level
Neopterin (nmol/L)
Time frame: 3 month
Serum Level
IL-1beta (pg/mL)
Time frame: 3 month
Serum Level
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 May 2023.
- Background: PubMed 20346316Thierer J, Acosta A, Vainstein N, Sultan M, Francesia A, Marino J, Prado AH, Guglielmone R, Trivi M, Boero L, Brites F, Anker S. Relation of left ventricular ejection fraction and functional capacity with metabolism and inflammation in chronic heart failure with reduced ejection fraction (from the MIMICA Study). Am J Cardiol. 2010 Apr 1;105(7):977-83. doi: 10.1016/j.amjcard.2009.11.017. Epub 2010 Feb 13.
- Background: PubMed 9768716de Groote P, Millaire A, Foucher-Hossein C, Nugue O, Marchandise X, Ducloux G, Lablanche JM. Right ventricular ejection fraction is an independent predictor of survival in patients with moderate heart failure. J Am Coll Cardiol. 1998 Oct;32(4):948-54. doi: 10.1016/s0735-1097(98)00337-4.
- 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.
Rehab H Werida, Ass. Prof. principal investigator
Damanhour University
Lamiaa Khedr, Ass. Prof. principal investigator
Tanta University
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 COPD and Right Heart Failure, run by Damanhour University at 1 site in Egypt.
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 0 inclusion and 1 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 May 2023. 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 Egypt. 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?
RAVI (ml/m2) (time frame: 3 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05366400, which also lists 2 linked publications.
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 May 2023.