Non-invasive assessment of oxygen levels in heart failure patients using MRI
Validation of a Non-invasive Assessment of Central Venous Oxygen Saturation by Using Magnetic Resonance Imaging
German Heart Institute · NCT05161884
This study tests a new, safer MRI method to check oxygen levels in people with heart failure to see if it works better than the usual invasive procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | German Heart Institute (other) |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05161884 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a non-invasive method for assessing central venous oxygen saturation using blood oxygen level-dependent (BOLD) MRI. It compares this technique against traditional right heart catheterization, which is an invasive procedure. The goal is to determine the diagnostic and prognostic value of this MRI method in patients with chronic heart failure. By utilizing MRI, the study seeks to provide a safer alternative for monitoring oxygen saturation in patients with cardiovascular conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have a clinical indication for right heart catheterization.
Not a fit: Patients who are under 18, pregnant, or have conditions that prevent informed consent or MRI compatibility may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a safer, non-invasive alternative for monitoring oxygen levels in heart failure patients.
How similar studies have performed: While the use of MRI for assessing oxygen saturation is promising, this specific validation against right heart catheterization has not been fully explored in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Where this trial is running
Berlin
- Deutsches Herzzentrum Berlin — Berlin, Germany (RECRUITING)
Study contacts
- Principal investigator: Sebastian Kelle — German Heart Center Berlin
- Study coordinator: Sebastian Kelle, MD, PhD
- Email: kelle@dhzb.de
- Phone: 00493045932400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure