An interventional study of CMRI and Gadolinium in Acromegaly, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-15.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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.
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 :
196 studies on the registry are indexed under Acromegaly; 18 are open to participants now.
This study's enrollment of 28 is below the median of 43 across 115 interventional studies indexed under Acromegaly.
Browse Acromegaly studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with acromegaly will be investigated
Device: CMRI · Drug: Gadolinium · Procedure: OGTT
Age-, sex- and BMI-matched healthy volunteers will be investigated
Device: CMRI · Drug: Gadolinium · Procedure: OGTT
Myocardial Imaging (CMRI) will be performed in patients (at baseline and 6 month after treatment) and healthy volunteers (baseline)
gadolinium injection will be performed during CMRI in patients and healthy volunteers.
Also known as: Gadolinium injection
Growth Hormon (GH) secretion and metabolic status of the acromegalic will be evaluated by an measure of plasma glucose, insulin and GH (OGTT), and insulin-like growth factor-1 (IGF-I) will be measured in patients and healthy volunteers.
Myocardial transverse relaxation time (T2), reflecting water content assessed by CMRI
This outcome will be compared between patients and healthy volunteers.
Time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Change from baseline Myocardial transverse relaxation time (T2) at 6 months, reflecting water content assessed by CMRI
Time frame: Baseline and 6 months after beginning of the treatment in acromegalic patients
Dense myocardial fibrosis
The dense myocardial fibrosis will be depicted by late gadolinium enhancement.
Time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Interstitial myocardial fibrosis
Interstitial myocardial fibrosis will be quantified by T1 measurements before and after gadolinium injection.
Time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Cardiac morphology will also be assessed CMRI
Time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Function including Left Ventricular mass index will also be assessed CMRI
Time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Function including Left Auricular ejection fractions will also be assessed CMRI
Time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Function including Left Ventricular ejection fractions will also be assessed CMRI
Time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Function including Right Ventricular ejection fractions will also be assessed CMRI
Time frame: 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
Time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Change from baseline Dense myocardial fibrosis at 6 months
"The dense myocardial fibrosis will be depicted by late gadolinium enhancement.
Time frame: Baseline and 6 months after beginning of the treatment in acromegalic patients
Change from baseline interstitial myocardial fibrosis at 6 months
Time frame: Baseline and 6 months after beginning of the treatment in acromegalic patients
Plan to share: No
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Assistance Publique - Hôpitaux de Paris