Heart Failure, DiastolicNCT05322109
Cardiac Magnetic Resonance Tomography for Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure, Diastolic, run by German Heart Institute at 1 site in Germany.
Trial summary
The diagnosis of heart failure with preserved ejection fraction has so far been made primarily according to criteria determined by echocardiography, or invasively by measuring the left ventricular filling pressures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Diastolic
- What is being tested?
- CMR
- How many people
- 190 participants
- Where
- 1 siteGermany
- Study dates
- 23 Apr 2021to 12 Dec 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: atients with CMR and left heart catheterization including LVEDP measurement within the same month
Who may be able to join
- Patients with CMR and left heart catheterization including LVEDP measurement within the same month
Who cannot join
- Severe Valve Dysfunction or Pericardial/Pleural Disease
- Contraindictaion for CR or Cath
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Cardiac Magnetic Resonance Tomography (CMR) for Heart Failure With Preserved Ejection Fraction (HFpEF)
The diagnosis of heart failure with preserved ejection fraction has so far been made primarily according to criteria determined by echocardiography, or invasively by measuring the left ventricular filling pressures. Increasingly, CMR is also evaluated with regard to the diagnosis of cardiac insufficiency with preserved pump function.However, it is still unclear which parameters can be used meaningfully for diagnostics.To answer this question, the investigators want to retrospectively evaluate data collected from patients with a clinical indication for CMR and coronary angiography.
Read the detailed description
Heart failure with preserved pump function is a common disease that is associated with a high level of suffering for the patient. The diagnosis has so far been made primarily according to criteria determined by echocardiography, or invasively by measuring the left ventricular filling pressures.
With its high spatial resolution and the possibility of tissue-specific diagnostics, cardiac MRI (CMR) offers outstanding possibilities in cardiac imaging without exposing the patient to ionizing radiation. Increasingly, CMR is also evaluated with regard to the diagnosis of cardiac insufficiency with preserved pump function. However, it is still unclear which parameters can be used meaningfully for diagnostics. There is evidence for a correlation with invasively increased LVEDP, although the number of patients examined in the previous studies was still small. In addition, possible influences from medication and clinical parameters were not examined.
To answer this question, the investigators want to retrospectively evaluate data collected from patients with a clinical indication. The significance of the study is that in the future CMR could supplement echocardiography in the diagnosis of HFpEF and further reduce the need for invasive diagnostics.
- Conditions
- Heart Failure, Diastolic
- Being tested
- CMR
- Keywords
- cardiac magnetic resonance, magnetic resonance imaging, lvedp
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMRDiagnostic test
Also called Cardiac magnetic resonance tomography
Clinically indicated cardiac magnetic resonance tomography executed according to international guideline recommendations.
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracellular myocardial volume (%)
Estimated percentage of extracellular volume of the myocardium
Measured: One montth
Left atrial volume (ml)
Volume of the left atrium in mililiters
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start23 Apr 2021
- Primary completion12 Dec 2021
- Study completion12 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, DiastolicStudies 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
- Retrospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Kelle, German Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322109
- Sponsor's protocol ID
- EA2/017/22
- Status last verified
- Apr 2022
- First submitted
- 3 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request anonymized IPD may be sharedn at the discretion of the PI.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Cardiac Magnetic Resonance Tomography (CMR) for Heart Failure With Preserved Ejection Fraction (HFpEF)
- ClinicalTrials.gov ID
- NCT05322109
- Acronym / sponsor ID
- EA2/017/22
- Conditions
- Heart Failure, Diastolic
- Keywords
- cardiac magnetic resonance, magnetic resonance imaging, lvedp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 11 Apr 2022 (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.
The diagnosis of heart failure with preserved ejection fraction has so far been made primarily according to criteria determined by echocardiography, or invasively by measuring the left ventricular filling pressures. Increasingly, CMR is also evaluated with regard to the diagnosis of cardiac insufficiency with preserved pump function.However, it is still unclear which parameters can be used meaningfully for diagnostics.To answer this question, the investigators want to retrospectively evaluate data collected from patients with a clinical indication for CMR and coronary angiography.
Detailed description
Heart failure with preserved pump function is a common disease that is associated with a high level of suffering for the patient. The diagnosis has so far been made primarily according to criteria determined by echocardiography, or invasively by measuring the left ventricular filling pressures.
With its high spatial resolution and the possibility of tissue-specific diagnostics, cardiac MRI (CMR) offers outstanding possibilities in cardiac imaging without exposing the patient to ionizing radiation. Increasingly, CMR is also evaluated with regard to the diagnosis of cardiac insufficiency with preserved pump function. However, it is still unclear which parameters can be used meaningfully for diagnostics. There is evidence for a correlation with invasively increased LVEDP, although the number of patients examined in the previous studies was still small. In addition, possible influences from medication and clinical parameters were not examined.
To answer this question, the investigators want to retrospectively evaluate data collected from patients with a clinical indication. The significance of the study is that in the future CMR could supplement echocardiography in the diagnosis of HFpEF and further reduce the need for invasive diagnostics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- atients with CMR and left heart catheterization including LVEDP measurement within the same month
Key inclusion criteria (1 listed)
- Patients with CMR and left heart catheterization including LVEDP measurement within the same month
Key exclusion criteria (2 listed)
- Severe Valve Dysfunction or Pericardial/Pleural Disease
- Contraindictaion for CR or Cath
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMRAlso: Cardiac magnetic resonance tomographyClinically indicated cardiac magnetic resonance tomography executed according to international guideline recommendations. | Diagnostic test | – |
Primary outcome
Extracellular myocardial volume (%)
Time frame: One montth
Estimated percentage of extracellular volume of the myocardium
Left atrial volume (ml)
Time frame: One month
Volume of the left atrium in mililiters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: Undecided. Upon reasonable request anonymized IPD may be sharedn at the discretion of the PI.
Related trials for Heart Failure, Diastolic
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingPhase 1
A Study of LY3971297 in Participants With Heart Failure
Heart Failure, Heart Failure, Diastolic
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Recruiting
Assessment of CCM in HF With Higher Ejection Fraction
Heart Failure, Heart Failure With Preserved Ejection Fraction
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.
The record lists no contact. Use the official record to reach the sponsor.
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, Diastolic, 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 2 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: finished, as of the sponsor's last update on 11 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracellular myocardial volume (%) (time frame: One montth). 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?
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 11 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.