Brief Title
Cardiac (CMRI) Assessment of Acromegaly
Official Title
Cardiac Structure and Function in Acromegalic Patients: A Cardiac Magnetic Resonance Imaging Study
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.
Study Type
Interventional
Primary Outcome
Myocardial transverse relaxation time (T2), reflecting water content assessed by CMRI
Secondary Outcome
Dense myocardial fibrosis
Condition
Acromegaly
Intervention
CMRI
Study Arms / Comparison Groups
OGTT, CMRI with gadolinium in patients
Description: Patients with acromegaly will be investigated
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
28
Start Date
December 2014
Completion Date
February 28, 2019
Primary Completion Date
June 9, 2017
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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Philippe CHANSON, MD, PhDI, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02948322
Organization ID
P121004
Responsible Party
Sponsor
Study Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Pfizer
Study Sponsor
Philippe CHANSON, MD, PhDI, Principal Investigator, AP-HP, Bicêtre Hospital
Verification Date
October 2016