Effects of Aortic Valve Replacement on Myocardial T1 Values in Severe Aortic Valve Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change in T1 values from baseline to follow-up
研究概览
简要总结
Background: Severe aortic valve stenosis (AS) is the commonest valve disease. Aortic valve replacement (AVR) is primarily indicated when symptoms occur and/or when there is a drop in left ventricular ejection fraction. However, irreversible myocardial damage, such as replacement fibrosis, leads to increased morbidity and mortality despite treatment. Improved patient selection and timely treatment is thus warranted. T1 mapping, a non-invasive method to quantify myocardial fibrosis by cardiac magnetic resonance (CMR), could be a marker to guide treatment.
Aims: To investigate the change of myocardial fibrosis* in AS patients following AVR and if these changes are associated with disease and/or procedural characteristics.
Methods: This is an observational clinical trial. Approximately 60 patients with severe AS planned to undergo AVR (either surgical or transcatheter) at Rigshospitalet, Denmark will be included. Participants will undergo CMR before surgery and at a 1-year follow-up. Other assessments include clinical evaluation and blood sampling. The primary end-point is change in T1 values after AVR.
Hypotheses and perspectives: The investigators hypothesize that (1) myocardial fibrosis* will regress in patients undergoing AVR as a group, (2) the degree of myocardial fibrosis is positively correlated with the degree of symptoms, (3) the regression of myocardial fibrosis is greater in patients undergoing TAVR compared to SAVR, and (4) the regression of myocardial fibrosis is greater in patients with tricuspid aortic stenosis compared to bicuspid aortic stenosis. Ultimately, T1 mapping is a potential marker for improved patient selection for the timing of AVR.
* Estimated by T1 mapping
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Severe aortic valve stenosis (Vmax > 4 m/s and/or mean gradient >40 mmHg)
排除标准
- •Reduced left ventricular ejection fraction (<50%)
- •More than mild left-sided valvular insufficiency
- •Previous or planned primary coronary intervention (PCI) or coronary artery by-pass grafting (CABG)
- •Persistent atrial fibrillation
- •Contraindications for CMR (pregnancy, severe claustrophobia, magnetic metallic implants)
- •Pacemaker/ICD
研究组 & 干预措施
Severe aortic valve stenosis
Patients with severe AS, either symptomatic patients planned to undergo AVR as surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR), or asymptomatic patients managed with clinical surveillance.
干预措施: Aortic valve replacement (Procedure)
结局指标
主要结局
Change in T1 values from baseline to follow-up
时间窗: Through study completion, an average of 1 year
次要结局
- E/e' ratio(Through study completion, an average of 1 year)
- Concentration of Troponin T(Through study completion, an average of 1 year)
- Concentration of NT-Pro-BNP(Through study completion, an average of 1 year)
- Left ventricular strain(Through study completion, an average of 1 year)
- Extracellular volume(Through study completion, an average of 1 year)
- Left ventricular ejection fraction(Through study completion, an average of 1 year)
- New York Heart Association (NYHA) Classification(Through study completion, an average of 1 year)
- Left ventricular mass(Through study completion, an average of 1 year)
- Late gadolinium enhancement(Through study completion, an average of 1 year)
- Type of AVR(Through study completion, an average of 1 year)
- Native valve(Through study completion, an average of 1 year)
- Left ventricular volumes(Through study completion, an average of 1 year)
- Left atrial size(Through study completion, an average of 1 year)
- e' velocity(Through study completion, an average of 1 year)
- Tricuspid regurgitation velocity(Through study completion, an average of 1 year)
研究者
Katrine Aagaard Myhr
Principtal Investigator
Rigshospitalet, Denmark