Effects of Pulmonary Diseases and Their Treatment on Cardiac Function

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.

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 Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis; COPD; Bronchial Asthma
• Intervention / Treatment: Diagnostic test: Cardiac MRI

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Ayham Daher, M.D.; Phone Number: +492418088763; Email: adaher@ukaachen.de

Study Locations

• Germany
  • Aachen, Germany, 52062
    • Recruiting
    • University Hospital RWTH Aachen
    • Contact: Ayham Daher, M.D.; Phone Number: +492418088763; Email: adaher@ukaachen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD (ICS); COPD before initiation of inhaled corticosteroid therapy	Diagnostic test: Cardiac MRI; Cardiac MRI and Echocardiography before treatment initiation of pulmonary disease and 3 months thereafter; Other Names: Echocardiography
COPD (LTOT-NIV); COPD before initiation of long term oxygen therapy or domiciliary long-term non-invasive ventilation	Diagnostic test: Cardiac MRI; Cardiac MRI and Echocardiography before treatment initiation of pulmonary disease and 3 months thereafter; Other Names: Echocardiography
COPD (Roflumilast ); COPD before initiation of Roflumilast therapy	Diagnostic test: Cardiac MRI; Cardiac MRI and Echocardiography before treatment initiation of pulmonary disease and 3 months thereafter; Other Names: Echocardiography
Bronchial asthma (antibody); Bronchial asthma before initiation of antibody therapy	Diagnostic test: Cardiac MRI; Cardiac MRI and Echocardiography before treatment initiation of pulmonary disease and 3 months thereafter; Other Names: Echocardiography
Bronchial asthma (ICS); Bronchial asthma before initiation of inhaled corticosteroid therapy	Diagnostic test: Cardiac MRI; Cardiac MRI and Echocardiography before treatment initiation of pulmonary disease and 3 months thereafter; Other Names: Echocardiography
Pulmonary fibrosis; Pulmonary fibrosis before initiation of antifibrotic therapy	Diagnostic test: Cardiac MRI; Cardiac MRI and Echocardiography before treatment initiation of pulmonary disease and 3 months thereafter; Other Names: Echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
left-ventricular end-diastolic volume	left-ventricular end-diastolic volume before and after therapy	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	3 months
Left ventricular global longitudinal strain (physiological parameter)	Left ventricular global longitudinal strain (physiological parameter) before and after therapy	3 months

Collaborators and Investigators

• Sponsor: Ayham Daher

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): September 14, 2026
• Study Completion (Estimated): December 14, 2026

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Fibrosis; Lung Diseases, Interstitial; Asthma; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: Uniklinik RWTH Aachen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No