Cardiac Structure and Function in Acromegalic Patients: A Cardiac Magnetic Resonance Imaging Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Myocardial transverse relaxation time (T2), reflecting water content assessed by CMRI
研究概览
简要总结
In this study, the investigators will evaluate the cardiac structure and function, focusing on the myocardial water content and interstitial fibrosis, in patients with active acromegaly in comparison with 1) healthy volunteers, 2) the same acromegalic patients that have received efficient therapy.
The investigators hypothesize that the myocardial water content in acromegaly is increased as these patients present with sodium and water retention and that this myocardial water infiltration will improve with efficient treatment of the disease. They will thus assess using CMRI, this parameter by measuring the myocardial transverse relaxation time (T2), reflecting water content in the myocardium.
详细描述
Patients with acromegaly have left ventricular (LV) hypertrophy and dysfunction on echocardiography, but only very few studies have been performed using cardiac magnetic resonance imaging (CMRI), currently the reference modality is assessment in cardiac geometry function. In addition, no data are available on right ventricular (RV) and atrial structure and function. The pathophysiology of the cardiac involvement in acromegaly may be related to increase myocardiac water content and/or interstitial myocardiac fibrosis.
The main objective of sthe study is to compare the myocardial water content in patients with acromegaly and in healthy volunteers. Secondary objectives of the study are to evaluate :
- interstitial fibrosis and the structure and the function of LV and RV in acromegalic patients in comparison with healthy volunteers;
- the reversibility of the cardiac involvement (water content, fibrosis, LV and RV structure and function) after efficient treatment of acromegaly;
- the elasticity of aorta in acromegalic patients in comparison with healthy volunteers and with the post-treatment state. Twenty acromegalic patients will be included in order to dispose of 15 patients that will completed the study and the same number of age- and BMI-adjusted healthy volunteers will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Active acromegaly as defined by the usual diagnostic criteria (de novo patients or patients uncontrolled by previous treatments).
- •Healthy volunteers matched for age, sex and BMI with the patients of the group 1
排除标准
- •History of coronary heart disease (acute or chronic myocardial ischemia)
- •Acute or chronic renal failure (creatinin clearance 30 mL/min/l,73m2)
- •Contraindication of MRI
- •Hypersensitivity to gadolinium
- •Pregnancy
研究组 & 干预措施
OGTT, CMRI with gadolinium in patients
Patients with acromegaly will be investigated
干预措施: CMRI (Device)
OGTT, CMRI with gadolinium in patients
Patients with acromegaly will be investigated
干预措施: Gadolinium (Drug)
OGTT, CMRI with gadolinium in patients
Patients with acromegaly will be investigated
干预措施: OGTT (Procedure)
OGTT, CMRI with gadolinium in volunteers
Age-, sex- and BMI-matched healthy volunteers will be investigated
干预措施: CMRI (Device)
OGTT, CMRI with gadolinium in volunteers
Age-, sex- and BMI-matched healthy volunteers will be investigated
干预措施: Gadolinium (Drug)
OGTT, CMRI with gadolinium in volunteers
Age-, sex- and BMI-matched healthy volunteers will be investigated
干预措施: OGTT (Procedure)
结局指标
主要结局
Myocardial transverse relaxation time (T2), reflecting water content assessed by CMRI
时间窗: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
This outcome will be compared between patients and healthy volunteers.
Change from baseline Myocardial transverse relaxation time (T2) at 6 months, reflecting water content assessed by CMRI
时间窗: Baseline and 6 months after beginning of the treatment in acromegalic patients
次要结局
- Function including Left Auricular ejection fractions will also be assessed CMRI(Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers)
- Interstitial myocardial fibrosis(Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers)
- Function including Right Ventricular ejection fractions will also be assessed CMRI(Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers)
- Dense myocardial fibrosis(Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers)
- Function including Left Ventricular ejection fractions will also be assessed CMRI(Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers)
- Function including Left Ventricular and Right Ventricular stroke volumes will also be assessed CMRI(Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers)
- Cardiac morphology will also be assessed CMRI(Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers)
- Function including Left Ventricular mass index will also be assessed CMRI(Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers)
- Change from baseline interstitial myocardial fibrosis at 6 months(Baseline and 6 months after beginning of the treatment in acromegalic patients)
- Change from baseline Dense myocardial fibrosis at 6 months(Baseline and 6 months after beginning of the treatment in acromegalic patients)