Mechanisms of Excess Risk in Aortic Stenosis
MASTER
1 other identifier
observational
192
1 country
1
Brief Summary
Aortic stenosis (AS) is caused by narrowing of one of the main heart valves. Replacing the valve is the only treatment to prevent the heart from failing or death. The timing of replacement is currently often too late - half of patients are left with permanent scarring and a quarter die within 3.5 years. Studies are underway to see if earlier replacement makes a difference. But for those with scarring of the heart, there is currently no tailored treatment. I want to change this by understanding why and how patients with scar are dying and what the investigators can do to prevent this. In this study, the investigators will use a heart scan (MRI) to detect scarring before valve replacement. After replacement, patients will receive a tiny monitor (paper clip size), which the investigators inject underneath the skin. This monitor continuously checks the heartbeat and can detect increased body fluid due to heart failure. The investigators will monitor patients for an average of 3 years to see if scarring is linked to abnormal heart rhythms and heart failure. Once the investigators know how and why, the investigators can target patients with available medications and design studies using specialised treatments, eg defibrillator implantation, to protect patients with scar from dying.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2021
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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2020
CompletedFirst Posted
Study publicly available on registry
November 13, 2020
CompletedStudy Start
First participant enrolled
March 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 30, 2021
April 1, 2021
4.7 years
November 6, 2020
April 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Heart failure death or hospitalisation for heart failure.
5 years after aortic valve replacement
Burden of non-sustained VT
As assessed on implantable cardiac monitor (approximate battery life 2.5 years)
2.5 years after aortic valve replacement.
Secondary Outcomes (5)
All-cause mortality (all-cause and cardiovascular via NHS spine/death registration)
5 years after aortic valve replacement
change in functional capacity (6-minute walk test)
At 6 weeks and 12 months after aortic valve replacement.
Heart failure symptoms
At 6 weeks and 12 months post aortic valve surgery
Heart failure symptoms
At 6 weeks and 12 months post aortic valve surgery
Burden of other serious arrhythmias requiring change in management
2.5 years after aortic valve replacement
Study Arms (1)
Main study
Patients with severe, symptomatic aortic stenosis will be recruited and followed up with primary outcome of heart failure death and hospitalisation (n=192). Of these, 170 will have an implantable cardiac monitor placed to detect presence and burden of non-sustained VT.
Interventions
Cardiac MRI scan pre- and post- aortic valve replacement to assess degree of left ventricular remodelling, fibrosis and myocardial blood flow.
Blood tests looking evidence of cardiac structural remodelling and function.
Validated assessment of functional capacity - distance walked over 6 minute time frame.
Ultrasound assessment of heart structure and function. Standard of care in valve surgery pathway.
Eligibility Criteria
This is a prospective single centre, observational cohort study of patients with symptomatic severe AS (n=192) undergoing clinically indicated AVR (surgical or transcatheter) and multiparametric assessment by CMR prior to AVR.
You may qualify if:
- Patients with symptomatic severe aortic stenosis referred for surgical or transcatheter AVR (one out of: effective orifice area \[EOA\] \<1.0 cm2 , indexed EOA of 0.6cm/m2, peak velocity \>4.0 m/s or mean gradient \>40mmHg).
You may not qualify if:
- More than moderate valve disease other than AS
- Diagnosis of dilated or hypertrophic cardiomyopathy, pregnancy/breast feeding
- eGFR \<30ml/min, CMR incompatible devices
- Inability to complete the protocol
- Other conditions that would prevent participation in the study.
- Adenosine perfusion will not be performed in patients with AV block, severe asthma/COPD or LVEF\<40%.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- Barts & The London NHS Trustcollaborator
Study Sites (1)
Barts Heart Centre
London, EC1A 7BE, United Kingdom
Related Publications (1)
Bennett J, Thornton GD, Nitsche C, Gama FF, Aziminia N, Gul U, Shetye A, Kellman P, Davies RH, Moon JC, Treibel TA; Barts Valve and Imaging Group. Left Ventricular Hypertrophy in Aortic Stenosis: Early Cell and Matrix Regression 2 Months Post-Aortic Valve Replacement. Circ Cardiovasc Imaging. 2024 Dec;17(12):e017425. doi: 10.1161/CIRCIMAGING.124.017425. Epub 2024 Dec 4.
PMID: 39629586DERIVED
Biospecimen
Myocardial biopsy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2020
First Posted
November 13, 2020
Study Start
March 23, 2021
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
April 30, 2021
Record last verified: 2021-04