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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Sebastian Kelle, MD, PhD contact

00493045932400

kelle@dhzb.de

Sebastian Kelle contact

01751583634

sebastiankelle@gmx.de

Germany1 site, 1 recruiting
  • Deutsches Herzzentrum Berlin

    Berlin, 13353

    Sebastian Kelle, MD, PhD

    Recruiting

Other trials in Germany

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 groups in NCT05161884
Study groupRoleWhat they receive
Preclinical Study groupn=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 groupn=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 groupn=25 patients with pulmonary hypertension (definition: pulmonary arterial pressure (PAP) above 25 mmHg)
Valvular heart disease groupn=25 patients with valvular heart disease (at least moderate)
Ischemic cardiomyopathy groupn=25 patients with ischemic cardiomyopathy
HFpEF groupn=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.

  1. oxygenation within the blood measured with MRI versus catherization

    Comparison of the accuracy of BOLD MRI versus right heart catheterization (RHC)

    Measured: 1 Year

  2. 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.

  1. First posted17 Dec 2021
  2. Study start1 Apr 2021
  3. Primary completion30 Nov 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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)
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

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.

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