Assessment of Cardiac Function Using Combined Cardiovascular Magnetic Resonance and Cardiopulmonary Exercise Testing (CMR-CPET)

NCT04729777 | Unknown

• 2 other identifiers: 100358226101
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

What problems limit patients' response to exercise? Using exercise cardiac magnetic resonance imaging to assess the heart's response, with simultaneous measurement of respiratory oxygen and carbon dioxide levels to assess the lung and skeletal muscle responses, to identify the rate-limiting factors affecting different types of patient

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (9)

• Cardiac output (L/min) measured using aortic flow from PCMR measurements

  Cardiac output (L/min) measured using aortic flow from PCMR measurements measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise

  Change from Baseline at 3 months

• Ventricular volumes (mL) measured using volumetric measurements of both ventricles, at end-diastole and end-systole

  Ventricular volumes (mL) measured using volumetric measurements of both ventricles, at end-diastole and end-systole measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise

  Change from Baseline at 3 months

• Heart rate (bpm) from MRI ECG/heart rate monitor

  Heart rate (bpm) from MRI ECG/heart rate monitor measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise

  Change from Baseline at 3 months

• Blood pressure (mmHg) from MRI-compatible BP monitor

  Blood pressure (mmHg) from MRI-compatible BP monitor measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise

  Change from Baseline at 3 months

• Oxygen consumption (VO2, mL/min) from CPET machine

  Oxygen consumption (VO2, mL/min) from CPET machine measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise

  Change from Baseline at 3 months

• Carbon dioxide production (VCO2, mL/min) from CPET machine

  Carbon dioxide production (VCO2, mL/min) from CPET machine measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise

  Change from Baseline at 3 months

• Arteriovenous Oxygen Gradient (Muscle oxygen consumption, mlO2/100mL blood/min) calculated from Cardiac Output and VO2

  Arteriovenous Oxygen Gradient (Muscle oxygen consumption, mlO2/100mL blood/min) measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise calculated from Cardiac Output and VO2

  Change from Baseline at 3 months

• Respiratory exchange ratio (RER) from CPET machine

  Respiratory exchange ratio (RER) from CPET machine measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise

  Change from Baseline at 3 months

• Exercise duration (sec) measured using a timer from the start to the end of exercise

  Exercise duration (sec) measured using a timer from the start to the end of exercise measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise

  Change from Baseline at 3 months

Secondary Outcomes (7)

• Cardiac Troponin T (ng/L) measured using blood sample prior to scan

  through study completion, an average of 1 year

• N-terminal pro-BNP (ng/L) measured using blood sample prior to scan

  through study completion, an average of 1 year

• Haemoglobin (g/L) measured using blood sample prior to scan

  through study completion, an average of 1 year

• Autoantibody profile measured using blood sample prior to scan

  through study completion, an average of 1 year

• Invasive pulmonary pressures (PA systolic/diastolic/mean) in MR-RHC substudy measured using a pressure transducer at rest and after 1 min of exercise

  through study completion, an average of 1 year

Interventions

Combined Cardiovascular Magnetic Resonance and Cardiopulmonary Exercise Testing PROCEDURE

Clinical Cardiac MRI scan at rest with routine administration of gadolinium contrast agent. Participants then undergo the research component of the test which requires them to perform exercise, using a recumbent, MRI-compatible cycle ergometer, whilst their breathing is simultaneously analysed using a mask connected to a CPET machine, until they are limited by symptoms and they stop pedalling. Most participants will undergo only one scan. Some participants will be asked to have two or three such scans over 3 months to assess changes over time, and in response to standard treatment of pulmonary hypertension.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 - 80 years with symptoms of breathlessness on exertion, and under the care of cardiology, pulmonary hypertension or rheumatology clinics for non-ischaemic cardiovascular disease.

You may qualify if:

• Age 18-80 years
• Symptoms of breathlessness on exertion under the care of cardiology, pulmonary hypertension or rheumatology clinics for non-ischaemic cardiovascular disease
• Willing and able to provide written informed consent

You may not qualify if:

• Previous ischaemic heart disease (including angina, myocardial infarction, PCI, CABG)
• Unstable symptoms (including crescendo angina or angina at rest, and syncope on exercise)\*
• Arrhythmia\*\*
• Musculoskeletal disease preventing exercise
• Patients unable to provide consent
• General contraindications to CMR (e.g. implanted metal objects, pregnancy, severe claustrophobia)
• Significant parenchymal lung disease (defined as \>20% extent parenchymal disease on CT)
• WHO functional class IV symptoms \*Patients with unstable symptoms have been excluded as it would be unsafe for them to perform exercise whilst in a MRI scanner. Patients unable to exercise, WHO functional class IV and those with significant lung disease have been excluded as they would be unable to complete the exercise protocol \*\*The researchers have excluded patients with arrhythmia as this can reduce the reliability of some of the CMR image sequences and also results in less predictable heart rate response to exercise

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust: lead
• Actelion: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

Royal Free Hospital NHS Foundation Trust

London, NW3 2QG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Central Study Contacts

James Brown

CONTACT

+44 (0)2074332780; james.brown1@nhs.net

Study Design

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

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: January 28, 2021
• Study Start: March 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)