Heart FailureNCT05161884
Validation of a Non-invasive Assessment of Central Venous Oxygen Saturation by Using MRI
An observational study of Heart Failure, run by German Heart Institute at 1 site in Germany.
Trial summary
BOLD measured with MRI may be a useful noninvasive method for the assessment of right ventricular O2 saturation. A validation of this method against right heart catheterization has not been fully performed. Whether the method may have a diagnostic and prognostic role in chronic heart failure patients is unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 135 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All male and female patients (age ≥ 18 years) of the Cardiology Clinic at Campus Virchow Klinikum and Deutsches Herzzentrum Berlin will be screened with regard to inclusion and exclusion criteria. Patients eligible on the basis of these criteria will be included in the study after informed consent and written consent. I Part (validation) In the first part of the study (the validation), a total of 25 patients were to be scheduled for right heart catheterization. II part (clinical study) In the second part will be a total of 100 patients with dyspnea and clinical indication for MRI and 25 healthy control patients.
Who may be able to join
- Age > 18 years Ability to follow the study according to study protocol General ability to consent Presence of a written consent of the study participant Patients with a clinical indication for right heart catheterization
Who cannot join
- Age <18 years. Pregnancy (for women of childbearing age, a pregnancy test is performed if pregnancy is possible) or breastfeeding.
- Any condition that interferes with informed decision making General MRI exclusion criteria (pacemaker, defibrillator, intracranial aneurysm clips, metallic foreign bodies in the eyes) Any MRI exclusion criteria not listed here as determined by the performing MRI laboratory.
- Hemodynamically unstable patients (heart rate < 50/min, systolic blood pressure < 90 mmHg, circulatory support devices: IABP, Impella) Complex supra- or ventricular arrhythmia occurring at rest or on exertion Right ventricular thrombus Recent pulmonary embolism Pulmonary instability (oxygen depletion or peripheral oxygen saturation <90%) Chronic lung disease (FEV< 35% on spirometry) Claustrophobia Sensorineural hearing loss from 30 dB and tinnitus
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum Berlin
Berlin, 13353
Sebastian Kelle, MD, PhD
About this study
Official title: Validation of a Non-invasive Assessment of Central Venous Oxygen Saturation by Using Magnetic Resonance Imaging
BOLD measured with MRI may be a useful noninvasive method for the assessment of right ventricular O2 saturation. A validation of this method against right heart catheterization has not been fully performed. Whether the method may have a diagnostic and prognostic role in chronic heart failure patients is unclear.
Read the detailed description
Measurement of blood oxygen saturation (O2 saturation) is essential for the clinical evaluation of patients with cardiovascular disease, heart failure, and pulmonary disease. With the introduction of the right heart catheter, measurements of O2 saturation in the right heart, venae cavae, and pulmonary artery became readily available and have thus contributed significantly to our hemodynamic understanding of congenital and acquired heart disease. Furthermore, the introduction of a pulmonary artery catheter, which can be implanted within minutes at the bedside, allows better monitoring for critically ill patients in the intensive care unit. In acquired heart disease, O2 saturation provides important information about systemic oxygen delivery and consumption, making it essential for evaluating heart failure patients and patients with pulmonary arterial hypertension. Nevertheless, invasive catheter implantation is associated with not insignificant risks of complications and a noninvasive method has not yet been established.
The blood oxygen level-dependent (BOLD) effect has been established in recent years as an effective method to noninvasively measure O2 saturation using T2 magnetic resonance imaging (T2-MRI). BOLD effect-based oximetry has been found to provide noninvasive information about both blood oxygenation, myocardial oxygenation, and skeletal muscle oxygenation using MRI. The principle underlying this technique exploits the dependence of the T2- relaxation time on the oxygenation of hemoglobin, as well as the different magnetic properties of hemoglobin in the oxygenated and deoxygenated states. To establish the mathematical relationship between the T2 relaxation time of whole blood and O2 saturation, a Luz-Meiboom (L-M) model describing the transverse (T2) relaxation arising from the transfer of protons between a protein and a water solution was proposed. The application of this model has improved the "classical" BOLD sequences, which were only measurable in static tissue (myocardium), minimizing the large estimation variability in flows (ventricles and vessels), allowing a more quantitative measurement. With the increasing number of patients receiving transcatheter aortic valve implantation (TAVI) as well as being diagnosed with atypical pulmonary hypertension, a large number of patients with relevant comorbidities require invasive hemodynamic evaluation. Simultaneous evaluation of central venous SO2 (ScvO2) and cardiac function is highly desirable and could allow noninvasive staging of frail high-risk patients. The first pilot clinical study of this concept was recently published.
The first aim of the investigators is to determine the precision of non-invasive O2 saturation measurement using BOLD-T2-MRI in contrast to invasive O2 saturation measurement using a right heart catheter in patients.
The secondary objective of the study is to investigate the role of BOLD measurements as a diagnostic test in patients with dyspnea at presentation, at least NYHA class 2 and an indication for cardio MRI. In these patients, BOLD measurements will be performed both at rest and during exercise. A sensitivity analysis will be performed to determine the diagnostic value of BOLD measurements in different patient populations.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preclinical Study group | n=10 Landrace pigs The aim of the pre-clinical study was to assess the accuracy of BOLD-T2 MRI in acute systemic hyper- and hypoxemia in a porcine model in contrast to cardiac catheterization. | |
| Validation Study group | n=25 The patients have an indication for a right heart catheter examination. This is a routine diagnostic examination that is performed on these patients. Compared to the clinical routine, an additional MRI measurement will be performed. The measurement will be performed before the cardiac catheterization. For the MRI examination, the patient/subject is placed in a magnetic resonance imaging machine. The MRI examination initially includes approximately 15 minutes of standard images for orientation and determination of function, morphology, and tissue characteristics. This is followed by images to determine oxygen saturation in the ventricles (approximately 5 minutes). If a CMR examination is already planned for a patient for other reasons, this will only be extended by the recordings for the determination of oxygen saturation (approx. 5 minutes) at the time of study inclusion. During the MRI measurements, patients will also perform a stepper stress test. | |
| Pulmonary Hypertension group | n=25 patients with pulmonary hypertension (definition: pulmonary arterial pressure (PAP) above 25 mmHg) | |
| Valvular heart disease group | n=25 patients with valvular heart disease (at least moderate) | |
| Ischemic cardiomyopathy group | n=25 patients with ischemic cardiomyopathy | |
| HFpEF group | n=25 patients with HFpEF (heart failure with preserved ejection fraction, definition: EF over 50%, heart failure symptoms, elevated NT-proBNP over 400pg/ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation within the blood measured with MRI versus catherization
Comparison of the accuracy of BOLD MRI versus right heart catheterization (RHC)
Measured: 1 Year
differences in oxygenation within different heart failure groups
Analysis of the sensitivity of BOLD measurements as a new diagnostic method for dyspnea at first presentation for various clinical applications
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start1 Apr 2021
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Kelle, German Heart Institute
- Investigators
- Sebastian Kelle, Principal investigator, German Heart Center Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161884
- Sponsor's protocol ID
- EA4/118/20
- Status last verified
- Sep 2023
- First submitted
- 16 Nov 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alogna A, Faragli A, Kolp C, Doeblin P, Tanacli R, Confortola G, Oetvoes J, Perna S, Stehning C, Nagel E, Pieske BM, Post H, Kelle S. Blood-Oxygen-Level Dependent (BOLD) T2-Mapping Reflects Invasively Measured Central Venous Oxygen Saturation in Cardiovascular Patients. JACC Cardiovasc Imaging. 2023 Feb;16(2):251-253. doi: 10.1016/j.jcmg.2022.08.020. Epub 2022 Nov 16. No abstract available.
PubMed 36648039
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Non-invasive Assessment of Central Venous Oxygen Saturation by Using Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT05161884
- Acronym / sponsor ID
- EA4/118/20
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BOLD measured with MRI may be a useful noninvasive method for the assessment of right ventricular O2 saturation. A validation of this method against right heart catheterization has not been fully performed. Whether the method may have a diagnostic and prognostic role in chronic heart failure patients is unclear.
Detailed description
Measurement of blood oxygen saturation (O2 saturation) is essential for the clinical evaluation of patients with cardiovascular disease, heart failure, and pulmonary disease. With the introduction of the right heart catheter, measurements of O2 saturation in the right heart, venae cavae, and pulmonary artery became readily available and have thus contributed significantly to our hemodynamic understanding of congenital and acquired heart disease. Furthermore, the introduction of a pulmonary artery catheter, which can be implanted within minutes at the bedside, allows better monitoring for critically ill patients in the intensive care unit. In acquired heart disease, O2 saturation provides important information about systemic oxygen delivery and consumption, making it essential for evaluating heart failure patients and patients with pulmonary arterial hypertension. Nevertheless, invasive catheter implantation is associated with not insignificant risks of complications and a noninvasive method has not yet been established.
The blood oxygen level-dependent (BOLD) effect has been established in recent years as an effective method to noninvasively measure O2 saturation using T2 magnetic resonance imaging (T2-MRI). BOLD effect-based oximetry has been found to provide noninvasive information about both blood oxygenation, myocardial oxygenation, and skeletal muscle oxygenation using MRI. The principle underlying this technique exploits the dependence of the T2- relaxation time on the oxygenation of hemoglobin, as well as the different magnetic properties of hemoglobin in the oxygenated and deoxygenated states. To establish the mathematical relationship between the T2 relaxation time of whole blood and O2 saturation, a Luz-Meiboom (L-M) model describing the transverse (T2) relaxation arising from the transfer of protons between a protein and a water solution was proposed. The application of this model has improved the "classical" BOLD sequences, which were only measurable in static tissue (myocardium), minimizing the large estimation variability in flows (ventricles and vessels), allowing a more quantitative measurement. With the increasing number of patients receiving transcatheter aortic valve implantation (TAVI) as well as being diagnosed with atypical pulmonary hypertension, a large number of patients with relevant comorbidities require invasive hemodynamic evaluation. Simultaneous evaluation of central venous SO2 (ScvO2) and cardiac function is highly desirable and could allow noninvasive staging of frail high-risk patients. The first pilot clinical study of this concept was recently published.
The first aim of the investigators is to determine the precision of non-invasive O2 saturation measurement using BOLD-T2-MRI in contrast to invasive O2 saturation measurement using a right heart catheter in patients.
The secondary objective of the study is to investigate the role of BOLD measurements as a diagnostic test in patients with dyspnea at presentation, at least NYHA class 2 and an indication for cardio MRI. In these patients, BOLD measurements will be performed both at rest and during exercise. A sensitivity analysis will be performed to determine the diagnostic value of BOLD measurements in different patient populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Preclinical Study group | – | –n=10 Landrace pigs The aim of the pre-clinical study was to assess the accuracy of BOLD-T2 MRI in acute systemic hyper- and hypoxemia in a porcine model in contrast to cardiac catheterization. |
| Validation Study group | – | –n=25 The patients have an indication for a right heart catheter examination. This is a routine diagnostic examination that is performed on these patients. Compared to the clinical routine, an additional MRI measurement will be performed. The measurement will be performed before the cardiac catheterization. For the MRI examination, the patient/subject is placed in a magnetic resonance imaging machine. The MRI examination initially includes approximately 15 minutes of standard images for orientation and determination of function, morphology, and tissue characteristics. This is followed by images to determine oxygen saturation in the ventricles (approximately 5 minutes). If a CMR examination is already planned for a patient for other reasons, this will only be extended by the recordings for the determination of oxygen saturation (approx. 5 minutes) at the time of study inclusion. During the MRI measurements, patients will also perform a stepper stress test. |
| Pulmonary Hypertension group | – | –n=25 patients with pulmonary hypertension (definition: pulmonary arterial pressure (PAP) above 25 mmHg) |
| Valvular heart disease group | – | –n=25 patients with valvular heart disease (at least moderate) |
| Ischemic cardiomyopathy group | – | –n=25 patients with ischemic cardiomyopathy |
| HFpEF group | – | –n=25 patients with HFpEF (heart failure with preserved ejection fraction, definition: EF over 50%, heart failure symptoms, elevated NT-proBNP over 400pg/ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All male and female patients (age ≥ 18 years) of the Cardiology Clinic at Campus Virchow Klinikum and Deutsches Herzzentrum Berlin will be screened with regard to inclusion and exclusion criteria. Patients eligible on the basis of these criteria will be included in the study after informed consent and written consent. I Part (validation) In the first part of the study (the validation), a total of 25 patients were to be scheduled for right heart catheterization. II part (clinical study) In the second part will be a total of 100 patients with dyspnea and clinical indication for MRI and 25 healthy control patients.
Key inclusion criteria (1 listed)
- Age > 18 years Ability to follow the study according to study protocol General ability to consent Presence of a written consent of the study participant Patients with a clinical indication for right heart catheterization
Key exclusion criteria (3 listed)
- Age <18 years. Pregnancy (for women of childbearing age, a pregnancy test is performed if pregnancy is possible) or breastfeeding.
- Any condition that interferes with informed decision making General MRI exclusion criteria (pacemaker, defibrillator, intracranial aneurysm clips, metallic foreign bodies in the eyes) Any MRI exclusion criteria not listed here as determined by the performing MRI laboratory.
- Hemodynamically unstable patients (heart rate < 50/min, systolic blood pressure < 90 mmHg, circulatory support devices: IABP, Impella) Complex supra- or ventricular arrhythmia occurring at rest or on exertion Right ventricular thrombus Recent pulmonary embolism Pulmonary instability (oxygen depletion or peripheral oxygen saturation <90%) Chronic lung disease (FEV< 35% on spirometry) Claustrophobia Sensorineural hearing loss from 30 dB and tinnitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
oxygenation within the blood measured with MRI versus catherization
Time frame: 1 Year
Comparison of the accuracy of BOLD MRI versus right heart catheterization (RHC)
differences in oxygenation within different heart failure groups
Time frame: 1 Year
Analysis of the sensitivity of BOLD measurements as a new diagnostic method for dyspnea at first presentation for various clinical applications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 36648039Alogna A, Faragli A, Kolp C, Doeblin P, Tanacli R, Confortola G, Oetvoes J, Perna S, Stehning C, Nagel E, Pieske BM, Post H, Kelle S. Blood-Oxygen-Level Dependent (BOLD) T2-Mapping Reflects Invasively Measured Central Venous Oxygen Saturation in Cardiovascular Patients. JACC Cardiovasc Imaging. 2023 Feb;16(2):251-253. doi: 10.1016/j.jcmg.2022.08.020. Epub 2022 Nov 16. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Kelle principal investigator
German Heart Center Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by German Heart Institute at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Kelle, MD, PhD (00493045932400, kelle@dhzb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygenation within the blood measured with MRI versus catherization (time frame: 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05161884, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.