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Cardiac (CMRI) Assessment of Acromegaly (ACROCOEUR)

Primary Purpose

Acromegaly

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CMRI
Gadolinium
OGTT
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acromegaly focused on measuring Acromegaly,, water retention, myocardial fibrosis, left ventricular hypertrophy, left ventricular dysfunction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • AP-HP, Bicêtre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OGTT, CMRI with gadolinium in patients

OGTT, CMRI with gadolinium in volunteers

Arm Description

Patients with acromegaly will be investigated

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

Outcomes

Primary Outcome Measures

Myocardial transverse relaxation time (T2), reflecting water content assessed by CMRI
This outcome will be compared between patients and healthy volunteers.
Change from baseline Myocardial transverse relaxation time (T2) at 6 months, reflecting water content assessed by CMRI

Secondary Outcome Measures

Dense myocardial fibrosis
The dense myocardial fibrosis will be depicted by late gadolinium enhancement.
Interstitial myocardial fibrosis
Interstitial myocardial fibrosis will be quantified by T1 measurements before and after gadolinium injection.
Cardiac morphology will also be assessed CMRI
Function including Left Ventricular mass index will also be assessed CMRI
Function including Left Auricular ejection fractions will also be assessed CMRI
Function including Left Ventricular ejection fractions will also be assessed CMRI
Function including Right Ventricular ejection fractions will also be assessed CMRI
Function including Left Ventricular and Right Ventricular stroke volumes will also be assessed CMRI
Change from baseline Dense myocardial fibrosis at 6 months
"The dense myocardial fibrosis will be depicted by late gadolinium enhancement.
Change from baseline interstitial myocardial fibrosis at 6 months

Full Information

First Posted
December 8, 2015
Last Updated
May 14, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02948322
Brief Title
Cardiac (CMRI) Assessment of Acromegaly
Acronym
ACROCOEUR
Official Title
Cardiac Structure and Function in Acromegalic Patients: A Cardiac Magnetic Resonance Imaging Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
June 9, 2017 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 : interstitial fibrosis and the structure and the function of LV and RV in acromegalic patients in comparison with healthy volunteers; the reversibility of the cardiac involvement (water content, fibrosis, LV and RV structure and function) after efficient treatment of acromegaly; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly,, water retention, myocardial fibrosis, left ventricular hypertrophy, left ventricular dysfunction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OGTT, CMRI with gadolinium in patients
Arm Type
Experimental
Arm Description
Patients with acromegaly will be investigated
Arm Title
OGTT, CMRI with gadolinium in volunteers
Arm Type
Active Comparator
Arm Description
Age-, sex- and BMI-matched healthy volunteers will be investigated
Intervention Type
Device
Intervention Name(s)
CMRI
Intervention Description
Myocardial Imaging (CMRI) will be performed in patients (at baseline and 6 month after treatment) and healthy volunteers (baseline)
Intervention Type
Drug
Intervention Name(s)
Gadolinium
Other Intervention Name(s)
Gadolinium injection
Intervention Description
gadolinium injection will be performed during CMRI in patients and healthy volunteers.
Intervention Type
Procedure
Intervention Name(s)
OGTT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Myocardial transverse relaxation time (T2), reflecting water content assessed by CMRI
Description
This outcome will be compared between patients and healthy volunteers.
Time Frame
Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Title
Change from baseline Myocardial transverse relaxation time (T2) at 6 months, reflecting water content assessed by CMRI
Time Frame
Baseline and 6 months after beginning of the treatment in acromegalic patients
Secondary Outcome Measure Information:
Title
Dense myocardial fibrosis
Description
The dense myocardial fibrosis will be depicted by late gadolinium enhancement.
Time Frame
Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Title
Interstitial myocardial fibrosis
Description
Interstitial myocardial fibrosis will be quantified by T1 measurements before and after gadolinium injection.
Time Frame
Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Title
Cardiac morphology will also be assessed CMRI
Time Frame
Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Title
Function including Left Ventricular mass index will also be assessed CMRI
Time Frame
Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Title
Function including Left Auricular ejection fractions will also be assessed CMRI
Time Frame
Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Title
Function including Left Ventricular ejection fractions will also be assessed CMRI
Time Frame
Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Title
Function including Right Ventricular ejection fractions will also be assessed CMRI
Time Frame
Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Title
Function including Left Ventricular and Right Ventricular stroke volumes will also be assessed CMRI
Time Frame
Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Title
Change from baseline Dense myocardial fibrosis at 6 months
Description
"The dense myocardial fibrosis will be depicted by late gadolinium enhancement.
Time Frame
Baseline and 6 months after beginning of the treatment in acromegalic patients
Title
Change from baseline interstitial myocardial fibrosis at 6 months
Time Frame
Baseline and 6 months after beginning of the treatment in acromegalic patients

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe CHANSON, MD, PhDI
Organizational Affiliation
AP-HP, Bicêtre Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AP-HP, Bicêtre Hospital
City
Le Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Cardiac (CMRI) Assessment of Acromegaly

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