Cardiac (CMRI) Assessment of Acromegaly

Acromegaly Clinical Trial

— ACROCOEUR  

Official title:

Cardiac Structure and Function in Acromegalic Patients: A Cardiac Magnetic Resonance Imaging Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02948322
• Other study ID #: P121004
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: February 28, 2019

Study information

• Verified date: October 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 28, 2019
• Est. primary completion date: June 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Intervention

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

Drug:
• Gadolinium
gadolinium injection will be performed during CMRI in patients and healthy volunteers.

Procedure:
• 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.

Locations

Country	Name	City	State
France	AP-HP, Bicêtre Hospital	Le Kremlin Bicêtre

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Interstitial myocardial fibrosis	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
Secondary	Cardiac morphology will also be assessed CMRI		Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Secondary	Function including Left Ventricular mass index will also be assessed CMRI		Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Secondary	Function including Left Auricular ejection fractions will also be assessed CMRI		Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Secondary	Function including Left Ventricular ejection fractions will also be assessed CMRI		Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Secondary	Function including Right Ventricular ejection fractions will also be assessed CMRI		Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Secondary	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
Secondary	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
Secondary	Change from baseline interstitial myocardial fibrosis at 6 months		Baseline and 6 months after beginning of the treatment in acromegalic patients