Effects of Pulmonary Diseases and Their Treatment on Cardiac Function

NCT ID: NCT05042219

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2026-12-14

Brief 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. 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.

Conditions

COPD; Bronchial Asthma; Idiopathic Pulmonary Fibrosis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD (ICS)

COPD before initiation of inhaled corticosteroid therapy

Cardiac MRI

Intervention Type: DIAGNOSTIC_TEST

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

COPD (LTOT-NIV)

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

Cardiac MRI

Intervention Type: DIAGNOSTIC_TEST

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

COPD (Roflumilast )

COPD before initiation of Roflumilast therapy

Cardiac MRI

Intervention Type: DIAGNOSTIC_TEST

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

Bronchial asthma (antibody)

Bronchial asthma before initiation of antibody therapy

Cardiac MRI

Intervention Type: DIAGNOSTIC_TEST

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

Bronchial asthma (ICS)

Bronchial asthma before initiation of inhaled corticosteroid therapy

Cardiac MRI

Intervention Type: DIAGNOSTIC_TEST

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

Pulmonary fibrosis

Pulmonary fibrosis before initiation of antifibrotic therapy

Cardiac MRI

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Cardiac MRI

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Echocardiography

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ayham Daher

OTHER

Sponsor Role: lead

Responsible Party

Ayham Daher

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University Hospital RWTH Aachen

Aachen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Ayham Daher, M.D.

Role: CONTACT

adaher@ukaachen.de

+492418088763

Facility Contacts

Ayham Daher, M.D.

Role: primary

adaher@ukaachen.de

+492418088763

Other Identifiers

Uniklinik RWTH Aachen

Identifier Type: -

Identifier Source: org_study_id