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

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ClinicalTrials.gov Identifier: NCT02865577
Recruitment Status : Recruiting
First Posted : August 12, 2016
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
University Hospitals, Leicester
Information provided by (Responsible Party):
University of Leicester

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.


Condition or disease
Asthma Pulmonary Disease, Chronic Obstructive

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 86 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Right Heart Dysfunction and Pulmonary Hypertension Evaluation in Airway Disease Using Cardiac Magnetic Resonance
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Right ventricle End Diastolic volume assessed by cardiac magnetic resonance [ Time Frame: On the day of Cardiac Magnetic Resonance ]

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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

Airway Disease (Asthma and COPD)

  1. Participant is willing and able to give informed consent for participation in the study.
  2. Male or Female, aged 18 years or above.
  3. Participants diagnosed with Asthma or COPD with airflow limitation (FEV1% predicted < 80%) with no exacerbations for at least 4 weeks prior to study entry.
  4. Participant has no clinical contraindication for CMR scan.
  5. Able (in the Investigators opinion) and willing to comply with all study requirements.
  6. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Healthy Volunteers

  1. Participant is willing and able to give informed consent for participation in the study.
  2. Male or Female, aged 18 years or above.
  3. Healthy participant in good health with no past history of cardiovascular or respiratory disease.
  4. Participant has no clinical contraindication for CMR scan.
  5. Able (in the Investigators opinion) and willing to comply with all study requirements.
  6. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria:

Airway Disease (Asthma and COPD)

The participant may not enter the study if ANY of the following apply:

  1. Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
  2. Severe renal impairment eGFR < 30 ml/min.
  3. Contraindication for undergoing CMR scan including permanent pacemaker and surgical procedure within last 6 weeks.
  4. Unable to understand / read English
  5. 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:

  1. Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
  2. Severe renal impairment eGFR < 30 ml/min.
  3. Contraindication for undergoing CMR scan including permanent pacemaker and surgical procedure within last 6 weeks.
  4. Unable to understand / read English
  5. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865577


Contacts
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Contact: Beverley Hargadon Beverley.Hargadon@uhl-tr.nhs.uk

Locations
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United Kingdom
Glenfield Hospital Recruiting
Leicester, Leicestershire, United Kingdom, LE3 9QP
Contact: Sumit Gupta, PhD, FRCR    +44116 258 3370    sumit.gupta@le.ac.uk   
Sponsors and Collaborators
University of Leicester
University Hospitals, Leicester
Investigators
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Principal Investigator: Sumit Gupta, PhD, FRCR University of Leicester / University Hospitals of Leicester NHS Trust

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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT02865577     History of Changes
Other Study ID Numbers: 0519
171377 ( Other Identifier: Integrated Research Application System )
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hypertension
Lung Diseases
Hypertension, Pulmonary
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive