Clinical trial NCT02948322: Cardiac (CMRI) Assessment of Acromegaly
Official title: Cardiac Structure and Function in Acromegalic Patients: A Cardiac Magnetic Resonance Imaging Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acromegaly
Keywords: Acromegaly,
water retention
myocardial fibrosis
left ventricular hypertrophy
left ventricular dysfunction
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2016-10-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Myocardial transverse relaxation time (T2), reflecting water content assessed by CMRI
timeFrame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
measure: Change from baseline Myocardial transverse relaxation time (T2) at 6 months, reflecting water content assessed by CMRI
timeFrame: Baseline and 6 months after beginning of the treatment in acromegalic patients
Secondary outcomes:
measure: Dense myocardial fibrosis
timeFrame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
measure: Interstitial myocardial fibrosis
timeFrame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
measure: Cardiac morphology will also be assessed CMRI
timeFrame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
measure: Function including Left Ventricular mass index will also be assessed CMRI
timeFrame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
measure: Function including Left Auricular ejection fractions will also be assessed CMRI
timeFrame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
measure: Function including Left Ventricular ejection fractions will also be assessed CMRI
timeFrame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
measure: Function including Right Ventricular ejection fractions will also be assessed CMRI
timeFrame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
measure: Function including Left Ventricular and Right Ventricular stroke volumes will also be assessed CMRI
timeFrame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
measure: Change from baseline Dense myocardial fibrosis at 6 months
timeFrame: Baseline and 6 months after beginning of the treatment in acromegalic patients
measure: Change from baseline interstitial myocardial fibrosis at 6 months
timeFrame: Baseline and 6 months after beginning of the treatment in acromegalic patients
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
facility: AP-HP, Bicêtre Hospital
Study officials:
affiliation: AP-HP, Bicêtre Hospital
name: Philippe CHANSON, MD, PhDI
role: PRINCIPAL_INVESTIGATOR
References: