Mitral Regurgitation3D-PRIMENCT04442828
3D Echocardiography and Cardiovascular Prognosis in Mitral Regurgitation
An observational study of Mitral Regurgitation, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The 3D-PRIME study will analyse whether use of 3D echocardiography can improve risk stratification and cardiovascular outcome in patients with mitral regurgitation of different etiologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Use of 3D echocardiography in patient follow-up
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- 17 Apr 2020to Apr 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: A cohort of patients with chronic mitral regurgitation referred for clinical and echocardiographic assessment at the Heart Valve Clinic at Haukeland University Hospital in Bergen, Norway.
Who may be able to join
- Adult patients with primary or secondary mitral regurgitation (MR)
- MR of moderate or severe degree
- 3D echocardiographic examinations of >= good spatial and temporal resolution
Who cannot join
- Co-existence of another valve disease of severe degree
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5021
Dana Cramariuc, MD PhD, +4755970534, cdan@helse-bergen.no
Dana Cramariuc, MD PhD
About this study
Official title: 3D Echocardiography and Cardiovascular PRognosis In Mitral REgurgitation (3D-PRIME)
The 3D-PRIME study will analyse whether use of 3D echocardiography can improve risk stratification and cardiovascular outcome in patients with mitral regurgitation of different etiologies.
- Conditions
- Mitral Regurgitation
- Being tested
- Use of 3D echocardiography in patient follow-up
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of 3D echocardiography in patient follow-upDiagnostic test
Patients will undergo clinical and echocardiographic examination including detailed 3D echocardiography at study inclusion and at least one follow-up visit.
| Study group | Role | What they receive |
|---|---|---|
| Primary mitral regurgitation | Patients with mitral regurgitation due to mitral valve disease Receives: Diagnostic Test: Use of 3D echocardiography in patient follow-up | |
| Secondary mitral regurgitation | Patients with mitral regurgitation due to ventricular or atrial disease Receives: Diagnostic Test: Use of 3D echocardiography in patient follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiovascular event
Death, mitral valve intervention, heart failure hospitalization
Measured: 24 months
Secondary outcomes (3)
All-cause death
Measured: 24 months
Cardiovascular death
Measured: 24 months
Mitral valve intervention
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start17 Apr 2020
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442828
- Sponsor's protocol ID
- 106848
- Acronym
- 3D-PRIME
- Status last verified
- Sep 2023
- First submitted
- 19 Jun 2020
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cramariuc D, Berg-Hansen CE, Grymyr LMD, Sindre RB, Aas CL, Ajmone Marsan N, Hung J, Urheim S. Role of 3D left ventricular end-systolic volume in risk stratification and outcome prediction in significant mitral regurgitation. Eur Heart J Imaging Methods Pract. 2026 Jan 28;4(1):qyag016. doi: 10.1093/ehjimp/qyag016. eCollection 2026 Jan.
PubMed 41674514Berg-Hansen CE, Sindre RB, Grymyr LMD, Rogge B, Valeur AE, Urheim S, Hung J, Cramariuc D. Sex differences in left atrial volumes, mechanics, and stiffness in primary mitral regurgitation-a combined 2D and 3D echocardiographic study. Eur Heart J Cardiovasc Imaging. 2024 Jul 31;25(8):1118-1126. doi: 10.1093/ehjci/jeae072.
PubMed 38469654
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Echocardiography and Cardiovascular PRognosis In Mitral REgurgitation (3D-PRIME)
- ClinicalTrials.gov ID
- NCT04442828
- Acronym / sponsor ID
- 3D-PRIME / 106848
- Conditions
- Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 23 Jun 2020 (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 3D-PRIME study will analyse whether use of 3D echocardiography can improve risk stratification and cardiovascular outcome in patients with mitral regurgitation of different etiologies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary mitral regurgitation | – | Diagnostic Test: Use of 3D echocardiography in patient follow-upPatients with mitral regurgitation due to mitral valve disease |
| Secondary mitral regurgitation | – | Diagnostic Test: Use of 3D echocardiography in patient follow-upPatients with mitral regurgitation due to ventricular or atrial disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of patients with chronic mitral regurgitation referred for clinical and echocardiographic assessment at the Heart Valve Clinic at Haukeland University Hospital in Bergen, Norway.
Key inclusion criteria (3 listed)
- Adult patients with primary or secondary mitral regurgitation (MR)
- MR of moderate or severe degree
- 3D echocardiographic examinations of >= good spatial and temporal resolution
Key exclusion criteria (2 listed)
- Co-existence of another valve disease of severe degree
- Inability to give informed consent
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 |
|---|---|---|
| Use of 3D echocardiography in patient follow-upPatients will undergo clinical and echocardiographic examination including detailed 3D echocardiography at study inclusion and at least one follow-up visit. | Diagnostic test | Primary mitral regurgitation, Secondary mitral regurgitation |
Primary outcome
Major cardiovascular event
Time frame: 24 months
Death, mitral valve intervention, heart failure hospitalization
3 secondary outcomes
All-cause death
Time frame: 24 months
Cardiovascular death
Time frame: 24 months
Mitral valve intervention
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Derived from this study: PubMed 41674514Cramariuc D, Berg-Hansen CE, Grymyr LMD, Sindre RB, Aas CL, Ajmone Marsan N, Hung J, Urheim S. Role of 3D left ventricular end-systolic volume in risk stratification and outcome prediction in significant mitral regurgitation. Eur Heart J Imaging Methods Pract. 2026 Jan 28;4(1):qyag016. doi: 10.1093/ehjimp/qyag016. eCollection 2026 Jan.
- Derived from this study: PubMed 38469654Berg-Hansen CE, Sindre RB, Grymyr LMD, Rogge B, Valeur AE, Urheim S, Hung J, Cramariuc D. Sex differences in left atrial volumes, mechanics, and stiffness in primary mitral regurgitation-a combined 2D and 3D echocardiographic study. Eur Heart J Cardiovasc Imaging. 2024 Jul 31;25(8):1118-1126. doi: 10.1093/ehjci/jeae072.
- Individual participant dataSharing planned: No
Related trials for Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
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.
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 Mitral Regurgitation, run by Haukeland University Hospital at 1 site in Norway.
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 3 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: status not confirmed, as of the sponsor's last update on 25 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 Norway. 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 Dana Cramariuc, MD PhD (+4755976755, cdan@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cardiovascular event (time frame: 24 months). 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 NCT04442828, which also lists 2 linked publications.
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 25 Sep 2023.