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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OGTT, CMRI with gadolinium in patients | Experimental | Patients with acromegaly will be investigated |
|
| OGTT, CMRI with gadolinium in volunteers | Active Comparator | Age-, sex- and BMI-matched healthy volunteers will be investigated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMRI | Device | Myocardial Imaging (CMRI) will be performed in patients (at baseline and 6 month after treatment) and healthy volunteers (baseline) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial transverse relaxation time (T2), reflecting water content assessed by CMRI | This outcome will be compared between patients and healthy volunteers. | 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 | Baseline and 6 months after beginning of the treatment in acromegalic patients |
| Measure | Description | Time Frame |
|---|---|---|
| Dense myocardial fibrosis | The dense myocardial fibrosis will be depicted by late gadolinium enhancement. | Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers |
| Interstitial myocardial fibrosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe CHANSON, MD, PhDI | AP-HP, Bicêtre Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Bicêtre Hospital | Le Kremlin-Bicêtre | 94275 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37549351 | Derived | Wolf P, Bouazizi K, Kachenoura N, Piedvache C, Gallo A, Salenave S, Maione L, Young J, Prigent M, Lecoq AL, Kuhn E, Agostini H, Trabado S, Redheuil A, Chanson P, Kamenicky P. Increase in intracellular and extracellular myocardial mass in patients with acromegaly: a cardiac magnetic resonance imaging study. Eur J Endocrinol. 2023 Aug 2;189(2):199-207. doi: 10.1093/ejendo/lvad105. |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| D017379 | Hypertrophy, Left Ventricular |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| ID | Term |
|---|---|
| D005682 | Gadolinium |
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D028581 | Lanthanoid Series Elements |
| D008674 | Metals, Rare Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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| Gadolinium | Drug | gadolinium injection will be performed during CMRI in patients and healthy volunteers. |
|
|
| OGTT | Procedure | 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. |
|
Interstitial myocardial fibrosis will be quantified by T1 measurements before and after gadolinium injection.
| 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 |
| Function including Left Auricular ejection fractions will also be assessed CMRI | 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 Right 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 |
| Change from baseline Dense myocardial fibrosis at 6 months | "The dense myocardial fibrosis will be depicted by late gadolinium enhancement. | Baseline and 6 months after beginning of the treatment in acromegalic patients |
| Change from baseline interstitial myocardial fibrosis at 6 months | Baseline and 6 months after beginning of the treatment in acromegalic patients |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018754 | Ventricular Dysfunction |
| D008670 |
| Metals |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |