Right Heart Dysfunction and Pulmonary Hypertension Evaluation in Airway Disease Using Cardiac Magnetic Resonance

NCT02865577 | Completed DMC

• 2 other identifiers: 0519171377
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Poor function of the right side of the heart and rise in pressure of the blood vessels leading to the lungs are two main heart-related factors that are associated with worsening of airway disease. A relatively new method which uses magnetic field to create images of the heart called cardiac magnetic resonance (CMR) imaging shows immense promise in detailed and accurate assessment of the heart in patients with airway diseases. This project aims to assess the heart in patients with asthma and chronic obstructive pulmonary disease (COPD) as well as healthy participants using CMR to help us determine features on CMR that are different is patients with asthma and COPD compared to healthy participants. This may help with early identification of patients who are at risk of episodes of acute worsening of airway disease, called exacerbation, and potentially halt the progression of the heart dysfunction with currently available or new treatments. Study involves one visit at Glenfiled Hospital, Leicester, lasting approximately 4 hours. The visit will include following assessments: clinical history, health status, physical examination, electrocardiogram (ECG), blood tests, lung function testing, echocardiogram and CMR. Part of the study will involve a participant questionnaire in which the participants will rate their CMR experience. The results will potentially change the way CMR is undertaken. A sub-set of the participants will also be invited back to do a one off focus group discussing the CMR experience further.

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Right ventricle End Diastolic volume assessed by cardiac magnetic resonance

  On the day of Cardiac Magnetic Resonance

Study Arms (3)

Adult asthma

Adult asthma subjects with airflow limitation (FEV1% predicted \< 80%) will be recruited for this study. Participants will undergo following study assessments: 1. Clinical History 2. Health status and disease control questionnaires 3. Focused physical examination 4. Electrocardiogram (ECG) 5. Blood test 6. Spirometry 7. Echocardiogram 8. Cardiac magnetic resonance (CMR) imaging 9. CMR survey

Adult COPD

Adult COPD subjects with airflow limitation (FEV1% predicted \< 80%) will be recruited for this study. Participants will undergo following study assessments: 1. Clinical History 2. Health status and disease control questionnaires 3. Focused physical examination 4. Electrocardiogram (ECG) 5. Blood test 6. Spirometry 7. Echocardiogram 8. Cardiac magnetic resonance (CMR) imaging 9. CMR survey

Healthy participants

Healthy participants with no past history of cardiovascular or respiratory disease. Participants will undergo following study assessments: 1. Clinical History 2. Focused physical examination 3. Electrocardiogram (ECG) 4. Blood test 5. Spirometry 6. Echocardiogram 7. Cardiac magnetic resonance (CMR) imaging 8. CMR survey

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators plan to recruit a total of 86 participants for this study. Adult asthma and chronicobstructive airway disease (COPD) patients with airflow limitation (FEV1% predicted \< 80%) will be recruited for this study. Healthy participants with no past history of cardiovascular or respiratory disease will also be recruited. The investigators plan to recruit 33 participants (n=13 with FEV1% predicted \< 50%, n=20 with FEV1% predicted ≥ 50% and \< 80%) in each group with airway disease (COPD and asthma) and 20 healthy participants.

You may qualify if:

• Airway Disease (Asthma and COPD)
• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Participants diagnosed with Asthma or COPD with airflow limitation (FEV1% predicted \< 80%) with no exacerbations for at least 4 weeks prior to study entry.
• Participant has no clinical contraindication for CMR scan.
• Able (in the Investigators opinion) and willing to comply with all study requirements.
• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
• Healthy Volunteers
• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Healthy participant in good health with no past history of cardiovascular or respiratory disease.
• Participant has no clinical contraindication for CMR scan.
• Able (in the Investigators opinion) and willing to comply with all study requirements.
• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

You may not qualify if:

• Airway Disease (Asthma and COPD)
• The participant may not enter the study if ANY of the following apply:
• Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
• Severe renal impairment eGFR \< 30 ml/min.
• Contraindication for undergoing CMR scan including permanent pacemaker and surgical procedure within last 6 weeks.
• Unable to understand / read English
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
• Healthy Volunteers
• The participant may not enter the study if ANY of the following apply:
• Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
• Severe renal impairment eGFR \< 30 ml/min.
• Contraindication for undergoing CMR scan including permanent pacemaker and surgical procedure within last 6 weeks.
• Unable to understand / read English
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator

Study Sites (1)

Glenfield Hospital

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Storage of plasma extracted from the blood for biomarker (characteristic biological properties or molecules detected in blood that indicate normal or diseased processes in the body) analysis at a future date to complement similar ethically approved research at University of Leicester / University Hospitals of Leicester or other United Kingdom or international academic partners. The plasma will be stored anonymously at -80°C indefinitely atthe Leicester Respiratory Biomedical Research Unit.

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Sumit Gupta, PhD, FRCR

  University of Leicester / University Hospitals of Leicester NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 12, 2016
• Study Start: July 2, 2016
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)