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Effects of Pulmonary Diseases and Their Treatment on Cardiac Function

ConditionsCOPDBronchial AsthmaIdiopathic Pulmonary Fibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorAyham Daher

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Age > 18 years

Informed consent to participate in the study will sign

Disqualifiers

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 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).

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Cardiac MRI

    Diagnostic test

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

Treatment groups

120 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: COPD (ICS)1 intervention
Group B: COPD (LTOT-NIV)1 intervention
Group C: COPD (Roflumilast )1 intervention
Group D: Bronchial asthma (antibody)1 intervention
Group E: Bronchial asthma (ICS)1 intervention
Group F: Pulmonary fibrosis1 intervention

Trial outcomes

Primary outcomes

1

left-ventricular end-diastolic volume

left-ventricular end-diastolic volume before and after therapy

Time frame
3 months

Secondary outcomes

1

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

Time frame
3 months
2

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

Presence of myocardial fibrosis or edema (pathophysiological parameter: yes/no) before and after therapy

Time frame
3 months
3

Left ventricular global longitudinal strain (physiological parameter)

Left ventricular global longitudinal strain (physiological parameter) before and after therapy

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ayham Daher

Lead sponsor

RWTH Aachen University

Sponsor institution

Source ClinicalTrials.gov
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