Effects of Pulmonary Diseases and Their Treatment on Cardiac Function

COPD Clinical Trial

Official title:

The Relationship Between Pulmonary and Cardiac Dysfunction and the Cardiac Effects of Pulmonary Treatments: Cardiopulmonary MRI Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05042219
• Other study ID #: Uniklinik RWTH Aachen
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: September 14, 2024

Study information

• Verified date: June 2022
• Source: RWTH Aachen University
• Contact: Ayham Daher, M.D.
• Phone: +492418088763
• Email: adaher[@]ukaachen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 14, 2024
• Est. primary completion date: September 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma
• COPD
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Diagnostic Test:
• Cardiac MRI
Cardiac MRI and Echocardiography before treatment initiation of pulmonary disease and 3 months thereafter

Locations

Country	Name	City	State
Germany	University Hospital RWTH Aachen	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
Ayham Daher

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left-ventricular end-diastolic volume	left-ventricular end-diastolic volume before and after therapy	3 months
Secondary	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
Secondary	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
Secondary	Left ventricular global longitudinal strain (physiological parameter)	Left ventricular global longitudinal strain (physiological parameter) before and after therapy	3 months