Effects of Pulmonary Diseases and Their Treatment on Cardiac Function

Ayham Daher

Status: Enrolling

Conditions: Bronchial Asthma; COPD; Idiopathic Pulmonary Fibrosis

Treatments: Diagnostic Test: Cardiac MRI

Study type: Observational

Funder types: Other

Identifiers

NCT05042219

Uniklinik RWTH Aachen

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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 design

120 participants in 6 patient groups

COPD (ICS)

Description:

COPD before initiation of inhaled corticosteroid therapy

Treatment:

Diagnostic Test: Cardiac MRI

COPD (LTOT-NIV)

Description:

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

Treatment:

Diagnostic Test: Cardiac MRI

COPD (Roflumilast )

Description:

COPD before initiation of Roflumilast therapy

Treatment:

Diagnostic Test: Cardiac MRI

Bronchial asthma (antibody)

Description:

Bronchial asthma before initiation of antibody therapy

Treatment:

Diagnostic Test: Cardiac MRI

Bronchial asthma (ICS)

Description:

Bronchial asthma before initiation of inhaled corticosteroid therapy

Treatment:

Diagnostic Test: Cardiac MRI

Pulmonary fibrosis

Description:

Pulmonary fibrosis before initiation of antifibrotic therapy

Treatment:

Diagnostic Test: Cardiac MRI