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NCT Number: NCT05042219

Effects of Pulmonary Diseases and Their Treatment on Cardiac Function

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac MRI

Diagnostic Test

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

Other names: Echocardiography

Primary outcomes

  1. left-ventricular end-diastolic volume

    Time frame: 3 months

    left-ventricular end-diastolic volume before and after therapy

Secondary outcomes

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

    Time frame: 3 months

    Pulmonary microvascular blood flow (physiological parameter: ml/min/100 ml Lung volume) before and after therapy

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

    Time frame: 3 months

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

  3. Left ventricular global longitudinal strain (physiological parameter)

    Time frame: 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ayham Daher, M.D.

CONTACT

[email protected]

+492418088763

Sponsors and collaborators

Lead sponsor

Ayham Daher

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2021
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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