EU-IPFF committed to promoting research in Pulmonary Fibrosis

Effects of Pulmonary Diseases and Their Treatment on Cardiac Function

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 99 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients with chronic lung disease requiring treatment (COPD, asthma, or pulmonary fibrosis).

- Age > 18 years.

- Informed consent to participate in the study will sign.

Exclusion Criteria:

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05042219
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ayham Daher
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	COPD, Bronchial Asthma, Idiopathic Pulmonary Fibrosis

Arms & Interventions

Arms

: COPD (ICS)

COPD before initiation of inhaled corticosteroid therapy

: COPD (LTOT-NIV)

COPD before initiation of long term oxygen therapy or domiciliary long-term non-invasive ventilation

: COPD (Roflumilast )

COPD before initiation of Roflumilast therapy

: Bronchial asthma (antibody)

Bronchial asthma before initiation of antibody therapy

: Bronchial asthma (ICS)

Bronchial asthma before initiation of inhaled corticosteroid therapy

: Pulmonary fibrosis

Pulmonary fibrosis before initiation of antifibrotic therapy

Interventions

Diagnostic Test: - Cardiac MRI

Cardiac MRI and Echocardiography before treatment initiation of pulmonary disease and 3 months thereafter

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.