Magnetic Resonance Imaging and Fibrosis
MRF
1 other identifier
observational
60
1 country
1
Brief Summary
Aortic valve disease causes impaired let ventricular function (LVF) due to hypertrophy, dilatation and diffuse myocardial fibrosis yet the prognostic effect of fibrosis, waiting time for operation and postoperative exercise training is presently unknown. The investigators aim to (1) determine the changes in LVF for patients on the waiting list; (2) establish non-invasive diagnostics for diffuse myocardial fibrosis; (3) relate LVF to fibrosis and physical capacity. The unique design (echocardiography, cardiopulmonary exercise test, cardiac magnetic resonance tomography and myocardial biopsy on the same patients) makes it possible to establish relationship between results of histology and imaging; quantifying and qualifying fibrosis in vivo, evaluate LVF vs. general cardiopulmonary function and optimize health care prior to and after operation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 26, 2016
CompletedFirst Posted
Study publicly available on registry
June 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedFebruary 21, 2021
February 1, 2021
5.6 years
April 26, 2016
February 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Left ventricular function:
a composite measure of ejection fraction = EF (%); left ventricular wall thickness lateralt and septalt (mm), left ventricular volumes (ml)
1 year
Degree of fibrosis
semi-quantitative scale 1-4
1 year
Secondary Outcomes (2)
Diastolic Function
1 year
Physical capacity
1 year
Study Arms (1)
Aortic valve disease
Patients with aortic stenosis referred to surgery. Exclusion criteria are concomitant heart valve disease, congenital heart disease, hemodynamic instability, previous cardiac surgery, history of myocardial infarction and coronary artery disease.
Eligibility Criteria
60 pts with severe AS but without any other concomitant heart valve disease
You may qualify if:
- patients with aortic valve disease
You may not qualify if:
- concomitant cardiac co-morbidity,
- concomitant surgical intervention,
- symptomatic lung disease,
- mental or physical disability limiting participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Vascular and Cardiothoracic Surgery, University Hospital Linkoping
Linköping, 581 85, Sweden
Related Publications (1)
Nilsson H, Bellander C, Carlen A, Nylander E, Hedman K, Tamas E. Systolic blood pressure response during exercise testing in symptomatic severe aortic stenosis. Open Heart. 2025 Jan 21;12(1):e003084. doi: 10.1136/openhrt-2024-003084.
PMID: 39842940DERIVED
Biospecimen
Endomyocardial biopsy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- university lecturer
Study Record Dates
First Submitted
April 26, 2016
First Posted
June 3, 2016
Study Start
June 1, 2015
Primary Completion
January 1, 2021
Study Completion
January 1, 2021
Last Updated
February 21, 2021
Record last verified: 2021-02