Effects of Pulmonary Diseases and Their Treatment on Cardiac Function

Recruiting

• Conditions: Bronchial Asthma; Idiopathic Pulmonary Fibrosis; COPD
• Interventions: Diagnostic Test: Cardiac MRI

• Registration Number: NCT05042219
• Lead Sponsor: Ayham Daher

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-13
• Study Start: 2022-06-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16
• Primary Completion: 2026-09-14
• Study Completion: 2026-12-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD (ICS)	Cardiac MRI	COPD before initiation of inhaled corticosteroid therapy
COPD (Roflumilast )	Cardiac MRI	COPD before initiation of Roflumilast therapy
Bronchial asthma (ICS)	Cardiac MRI	Bronchial asthma before initiation of inhaled corticosteroid therapy
COPD (LTOT-NIV)	Cardiac MRI	COPD before initiation of long term oxygen therapy or domiciliary long-term non-invasive ventilation
Bronchial asthma (antibody)	Cardiac MRI	Bronchial asthma before initiation of antibody therapy
Pulmonary fibrosis	Cardiac MRI	Pulmonary fibrosis before initiation of antifibrotic therapy

Primary Outcome Measures

Name	Time	Method
left-ventricular end-diastolic volume	3 months	left-ventricular end-diastolic volume before and after therapy

Secondary Outcome Measures

Name	Time	Method
Pulmonary microvascular blood flow (physiological parameter: ml/min/100 ml Lung volume)	3 months	Pulmonary microvascular blood flow (physiological parameter: ml/min/100 ml Lung volume) before and after therapy
Presence of myocardial fibrosis or edema (pathophysiological parameter: yes/no)	3 months	Presence of myocardial fibrosis or edema (pathophysiological parameter: yes/no) before and after therapy
Left ventricular global longitudinal strain (physiological parameter)	3 months	Left ventricular global longitudinal strain (physiological parameter) before and after therapy

Trial Locations

Locations (1)

University Hospital RWTH Aachen; 🇩🇪 Aachen, Germany