Effects of Pulmonary Diseases and Their Treatment on Cardiac Function

NCT05042219 | Recruiting

• 1 other identifier: Uniklinik RWTH Aachen
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• left-ventricular end-diastolic volume

  left-ventricular end-diastolic volume before and after therapy

  3 months

Secondary Outcomes (3)

• Pulmonary microvascular blood flow (physiological parameter: ml/min/100 ml Lung volume)

  3 months

• Presence of myocardial fibrosis or edema (pathophysiological parameter: yes/no)

  3 months

• Left ventricular global longitudinal strain (physiological parameter)

  3 months

Study Arms (6)

COPD (ICS)

COPD before initiation of inhaled corticosteroid therapy

Diagnostic Test: Cardiac MRI

COPD (LTOT-NIV)

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

Diagnostic Test: Cardiac MRI

COPD (Roflumilast )

COPD before initiation of Roflumilast therapy

Diagnostic Test: Cardiac MRI

Bronchial asthma (antibody)

Bronchial asthma before initiation of antibody therapy

Diagnostic Test: Cardiac MRI

Bronchial asthma (ICS)

Bronchial asthma before initiation of inhaled corticosteroid therapy

Diagnostic Test: Cardiac MRI

Pulmonary fibrosis

Pulmonary fibrosis before initiation of antifibrotic therapy

Diagnostic Test: Cardiac MRI

Interventions

Cardiac MRI DIAGNOSTIC_TEST

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

Also known as: Echocardiography

Bronchial asthma (ICS); Bronchial asthma (antibody); COPD (ICS); COPD (LTOT-NIV); COPD (Roflumilast ); Pulmonary fibrosis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patients with chronic lung disease requiring treatment (COPD, asthma, or pulmonary fibrosis).
• Age \> 18 years
• Informed consent to participate in the study will sign

You may not qualify if:

• 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

Sponsors & Collaborators

• Ayham Daher: lead

Study Sites (1)

University Hospital RWTH Aachen

Aachen, 52062, Germany

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Idiopathic Pulmonary Fibrosis

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pulmonary Fibrosis; Lung Diseases, Interstitial

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Ayham Daher, M.D.

CONTACT

+492418088763; adaher@ukaachen.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 13, 2021
• Study Start: June 1, 2022
• Primary Completion (Estimated): September 14, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

DE (1)