AP-HP, Bicêtre Hospital
Le Kremlin-Bicêtre, 94275, France
NCT Number: NCT02948322
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Le Kremlin-Bicêtre, 94275, France
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 :
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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.
Time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
This outcome will be compared between patients and healthy volunteers.
Time frame: Baseline and 6 months after beginning of the treatment in acromegalic patients
Time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
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 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
Time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Time frame: Baseline and 6 months after beginning of the treatment in acromegalic patients
"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
Assistance Publique - Hôpitaux de Paris
Other
Cardiac Structure and Function in Acromegalic Patients: A Cardiac Magnetic Resonance Imaging Study
Acronym: ACROCOEUR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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