Cardiac (CMRI) Assessment of Acromegaly

NCT ID: NCT02948322

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2019-02-28

Brief Summary

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.

Detailed Description

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 :

1. interstitial fibrosis and the structure and the function of LV and RV in acromegalic patients in comparison with healthy volunteers;

2. the reversibility of the cardiac involvement (water content, fibrosis, LV and RV structure and function) after efficient treatment of acromegaly;

3. 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.

Conditions

Acromegaly

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

OGTT, CMRI with gadolinium in patients

Patients with acromegaly will be investigated

Group Type: EXPERIMENTAL

CMRI

Intervention Type: DEVICE

Myocardial Imaging (CMRI) will be performed in patients (at baseline and 6 month after treatment) and healthy volunteers (baseline)

Gadolinium

Intervention Type: DRUG

gadolinium injection will be performed during CMRI in patients and healthy volunteers.

OGTT

Intervention Type: 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.

OGTT, CMRI with gadolinium in volunteers

Age-, sex- and BMI-matched healthy volunteers will be investigated

Group Type: ACTIVE_COMPARATOR

CMRI

Intervention Type: DEVICE

Myocardial Imaging (CMRI) will be performed in patients (at baseline and 6 month after treatment) and healthy volunteers (baseline)

Gadolinium

Intervention Type: DRUG

gadolinium injection will be performed during CMRI in patients and healthy volunteers.

OGTT

Intervention Type: 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.

Interventions

CMRI

Myocardial Imaging (CMRI) will be performed in patients (at baseline and 6 month after treatment) and healthy volunteers (baseline)

Intervention Type: DEVICE

Gadolinium

gadolinium injection will be performed during CMRI in patients and healthy volunteers.

Intervention Type: DRUG

OGTT

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.

Intervention Type: PROCEDURE

Other Intervention Names

Gadolinium injection

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe CHANSON, MD, PhDI

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Bicêtre Hospital

Locations

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 37549351 (View on PubMed)

Other Identifiers

P121004

Identifier Type: -

Identifier Source: org_study_id