COPDNCT05042219
Effects of Pulmonary Diseases and Their Treatment on Cardiac Function
An observational study of COPD and Bronchial Asthma, run by Ayham Daher at 1 site in Germany.
Trial summary
While the bidirectional relationship between the lung and the right heart are well studied, the cardiopulmonary interactions between the lung and the left heart are largely unresearched and not well understood. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COPD, Bronchial Asthma, Idiopathic Pulmonary Fibrosis
- What is being tested?
- Cardiac MRI
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2022to 14 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Patients with COPD group D and new prescription of ICS therapy. * Patients with COPD and new prescription of long-term O2 therapy or domiciliary long-term non-invasive ventilation. * Patients with COPD and new prescription of Roflumilast therapy. * Patients with bronchial asthma and new prescription of antibody therapy. * Patients with bronchial asthma at initial diagnosis and new prescription of ICS mono-therapy. * Patients with initial diagnosis of pulmonary fibrosis and new prescription of antifibrotic therapy (nintedanib or pirfinidone).
Who may be able to join
- Patients with chronic lung disease requiring treatment (COPD, asthma, or pulmonary fibrosis).
- Age > 18 years
- Informed consent to participate in the study will sign
Who cannot join
- Individuals who are not fully capable of giving consent and understanding the nature, significance and scope of the study.
- Patients with contraindications to MRI examination (eg, pacemaker, severe claustrophobia) or to contrast medium use (severe renal insufficiency or glomerular filtration rate <30 ml/min, known gadolinium contrast medium allergy)
- Patients with atrial fibrillation or other significant cardiac arrhythmias that interfere with cardiac MRI
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital RWTH Aachen
Aachen, 52062
Ayham Daher, M.D., +492418088763, adaher@ukaachen.de
About this study
Official title: The Relationship Between Pulmonary and Cardiac Dysfunction and the Cardiac Effects of Pulmonary Treatments: Cardiopulmonary MRI Analysis
While the bidirectional relationship between the lung and the right heart are well studied, the cardiopulmonary interactions between the lung and the left heart are largely unresearched and not well understood. However, in recent years, there is a growing evidence that partially explains the bidirectional interaction between COPD and left heart. Systemic inflammation with multiorgan involvement is thought to play a role in COPD as a systemic disease. Some therapeutic approaches to COPD also appear to influence these cardiopulmonary interactions. While understanding these interactions is very important for clinicians, scientific data are scarce. Cardiac magnetic resonance imaging (cardiac MRI) is the gold standard for assessing cardiac function and dimensions as well as myocardial inflammation. Despite this excellent suitability of cardiac MRI for the assessment of cardiovascular function, only few studies have investigated cardiac function and myocardial structure in patients with pulmonary disease using cardiac MRI. Such a study is therefore very important for understanding the effects of pulmonary disease and its management on the heart.
The objective is to determine cardiac function in patients with pulmonary disease and to analyze the cardiovascular effects of the treatment of the pulmonary disease.
Read more
Specifically, the following will be studied:
- Using cardiac MRI: Cardiac function and volumes and indications of myocardial fibrosis and edema in patients with chronic pulmonary disease at the time of first diagnosis.
- the vascular function of pulmonary arteries in these patients, also using cardiac MRI
- the relationship between pulmonary function parameters and cardiac dysfunction to identify patients at increased risk, if applicable.
- Echocardiographic assessment of left heart including strain analysis.
- the course of these cardiovascular parameters (using cardiac MRI and echocardiography) 3-6 months after initiation of guideline-based therapy for pulmonary disease.
- Conditions
- COPD, Bronchial Asthma, Idiopathic Pulmonary Fibrosis
- Being tested
- Cardiac MRI
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIDiagnostic test
Also called Echocardiography
Cardiac MRI and Echocardiography before treatment initiation of pulmonary disease and 3 months thereafter
| Study group | Role | What they receive |
|---|---|---|
| COPD (ICS) | COPD before initiation of inhaled corticosteroid therapy Receives: Diagnostic Test: Cardiac MRI | |
| COPD (LTOT-NIV) | COPD before initiation of long term oxygen therapy or domiciliary long-term non-invasive ventilation Receives: Diagnostic Test: Cardiac MRI | |
| COPD (Roflumilast ) | COPD before initiation of Roflumilast therapy Receives: Diagnostic Test: Cardiac MRI | |
| Bronchial asthma (antibody) | Bronchial asthma before initiation of antibody therapy Receives: Diagnostic Test: Cardiac MRI | |
| Bronchial asthma (ICS) | Bronchial asthma before initiation of inhaled corticosteroid therapy Receives: Diagnostic Test: Cardiac MRI | |
| Pulmonary fibrosis | Pulmonary fibrosis before initiation of antifibrotic therapy Receives: Diagnostic Test: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
left-ventricular end-diastolic volume
left-ventricular end-diastolic volume before and after therapy
Measured: 3 months
Secondary outcomes (3)
Pulmonary microvascular blood flow (physiological parameter: ml/min/100 ml Lung volume)
Pulmonary microvascular blood flow (physiological parameter: ml/min/100 ml Lung volume) before and after therapy
Measured: 3 months
Presence of myocardial fibrosis or edema (pathophysiological parameter: yes/no)
Presence of myocardial fibrosis or edema (pathophysiological parameter: yes/no) before and after therapy
Measured: 3 months
Left ventricular global longitudinal strain (physiological parameter)
Left ventricular global longitudinal strain (physiological parameter) before and after therapy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Jun 2022
- Primary completion14 Sep 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayham Daher
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayham Daher, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042219
- Sponsor's protocol ID
- Uniklinik RWTH Aachen
- Status last verified
- Jul 2024
- First submitted
- 2 Sep 2021
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Pulmonary and Cardiac Dysfunction and the Cardiac Effects of Pulmonary Treatments: Cardiopulmonary MRI Analysis
- ClinicalTrials.gov ID
- NCT05042219
- Acronym / sponsor ID
- Uniklinik RWTH Aachen
- Conditions
- COPD, Bronchial Asthma, Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ayham DaherUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 14 Sep 2026 (estimated)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 13 Sep 2021 (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.
While the bidirectional relationship between the lung and the right heart are well studied, the cardiopulmonary interactions between the lung and the left heart are largely unresearched and not well understood. However, in recent years, there is a growing evidence that partially explains the bidirectional interaction between COPD and left heart. Systemic inflammation with multiorgan involvement is thought to play a role in COPD as a systemic disease. Some therapeutic approaches to COPD also appear to influence these cardiopulmonary interactions. While understanding these interactions is very important for clinicians, scientific data are scarce. Cardiac magnetic resonance imaging (cardiac MRI) is the gold standard for assessing cardiac function and dimensions as well as myocardial inflammation. Despite this excellent suitability of cardiac MRI for the assessment of cardiovascular function, only few studies have investigated cardiac function and myocardial structure in patients with pulmonary disease using cardiac MRI. Such a study is therefore very important for understanding the effects of pulmonary disease and its management on the heart.
The objective is to determine cardiac function in patients with pulmonary disease and to analyze the cardiovascular effects of the treatment of the pulmonary disease.
Specifically, the following will be studied:
- Using cardiac MRI: Cardiac function and volumes and indications of myocardial fibrosis and edema in patients with chronic pulmonary disease at the time of first diagnosis.
- the vascular function of pulmonary arteries in these patients, also using cardiac MRI
- the relationship between pulmonary function parameters and cardiac dysfunction to identify patients at increased risk, if applicable.
- Echocardiographic assessment of left heart including strain analysis.
- the course of these cardiovascular parameters (using cardiac MRI and echocardiography) 3-6 months after initiation of guideline-based therapy for pulmonary disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| COPD (ICS) | – | Diagnostic Test: Cardiac MRICOPD before initiation of inhaled corticosteroid therapy |
| COPD (LTOT-NIV) | – | Diagnostic Test: Cardiac MRICOPD before initiation of long term oxygen therapy or domiciliary long-term non-invasive ventilation |
| COPD (Roflumilast ) | – | Diagnostic Test: Cardiac MRICOPD before initiation of Roflumilast therapy |
| Bronchial asthma (antibody) | – | Diagnostic Test: Cardiac MRIBronchial asthma before initiation of antibody therapy |
| Bronchial asthma (ICS) | – | Diagnostic Test: Cardiac MRIBronchial asthma before initiation of inhaled corticosteroid therapy |
| Pulmonary fibrosis | – | Diagnostic Test: Cardiac MRIPulmonary fibrosis before initiation of antifibrotic therapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with COPD group D and new prescription of ICS therapy. * Patients with COPD and new prescription of long-term O2 therapy or domiciliary long-term non-invasive ventilation. * Patients with COPD and new prescription of Roflumilast therapy. * Patients with bronchial asthma and new prescription of antibody therapy. * Patients with bronchial asthma at initial diagnosis and new prescription of ICS mono-therapy. * Patients with initial diagnosis of pulmonary fibrosis and new prescription of antifibrotic therapy (nintedanib or pirfinidone).
Key inclusion criteria (3 listed)
- Patients with chronic lung disease requiring treatment (COPD, asthma, or pulmonary fibrosis).
- Age > 18 years
- Informed consent to participate in the study will sign
Key exclusion criteria (4 listed)
- Individuals who are not fully capable of giving consent and understanding the nature, significance and scope of the study.
- Patients with contraindications to MRI examination (eg, pacemaker, severe claustrophobia) or to contrast medium use (severe renal insufficiency or glomerular filtration rate <30 ml/min, known gadolinium contrast medium allergy)
- Patients with atrial fibrillation or other significant cardiac arrhythmias that interfere with cardiac MRI
- Pregnancy and lactation
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 |
|---|---|---|
| Cardiac MRIAlso: EchocardiographyCardiac MRI and Echocardiography before treatment initiation of pulmonary disease and 3 months thereafter | Diagnostic test | Bronchial asthma (ICS), Bronchial asthma (antibody), COPD (ICS), COPD (LTOT-NIV), COPD (Roflumilast ), Pulmonary fibrosis |
Primary outcome
left-ventricular end-diastolic volume
Time frame: 3 months
left-ventricular end-diastolic volume before and after therapy
3 secondary outcomes
Pulmonary microvascular blood flow (physiological parameter: ml/min/100 ml Lung volume)
Time frame: 3 months
Presence of myocardial fibrosis or edema (pathophysiological parameter: yes/no)
Time frame: 3 months
Left ventricular global longitudinal strain (physiological parameter)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Bronchial Asthma, run by Ayham Daher at 1 site in Germany.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 Jul 2024. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayham Daher, M.D. (+492418088763, adaher@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left-ventricular end-diastolic volume (time frame: 3 months). 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 16 Jul 2024.