AcromegalyACROCOEURNCT02948322
Cardiac (CMRI) Assessment of Acromegaly
A study testing CMRI, Gadolinium and OGTT in people with Acromegaly, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acromegaly
- What is being tested?
- CMRI, Gadolinium and OGTT
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to 28 Feb 2019
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Structure and Function in Acromegalic Patients: A Cardiac Magnetic Resonance Imaging Study
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.
Read the 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.
- Conditions
- Acromegaly
- Being tested
- CMRI, Gadolinium, OGTT
- Keywords
- Acromegaly,, water retention, myocardial fibrosis, left ventricular hypertrophy, left ventricular dysfunction
- Medical subject headings
- Acromegaly, Hypertrophy, Left Ventricular, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMRIDevice
Myocardial Imaging (CMRI) will be performed in patients (at baseline and 6 month after treatment) and healthy volunteers (baseline)
GadoliniumDrug
Also called Gadolinium injection
gadolinium injection will be performed during CMRI in patients and healthy volunteers.
OGTTProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| OGTT, CMRI with gadolinium in patients | Experimental | Patients with acromegaly will be investigated Receives: Device: CMRI; Drug: Gadolinium; Procedure: OGTT |
| OGTT, CMRI with gadolinium in volunteers | Active comparator | Age-, sex- and BMI-matched healthy volunteers will be investigated Receives: Device: CMRI; Drug: Gadolinium; Procedure: OGTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial transverse relaxation time (T2), reflecting water content assessed by CMRI
This outcome will be compared between patients and healthy volunteers.
Measured: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Change from baseline Myocardial transverse relaxation time (T2) at 6 months, reflecting water content assessed by CMRI
Measured: Baseline and 6 months after beginning of the treatment in acromegalic patients
Secondary outcomes (10)
Dense myocardial fibrosis
The dense myocardial fibrosis will be depicted by late gadolinium enhancement.
Measured: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Interstitial myocardial fibrosis
Interstitial myocardial fibrosis will be quantified by T1 measurements before and after gadolinium injection.
Measured: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Cardiac morphology will also be assessed CMRI
Measured: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Function including Left Ventricular mass index will also be assessed CMRI
Measured: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Function including Left Auricular ejection fractions will also be assessed CMRI
Measured: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Function including Left Ventricular ejection fractions will also be assessed CMRI
Measured: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Function including Right Ventricular ejection fractions will also be assessed CMRI
Measured: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Function including Left Ventricular and Right Ventricular stroke volumes will also be assessed CMRI
Measured: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers
Change from baseline Dense myocardial fibrosis at 6 months
"The dense myocardial fibrosis will be depicted by late gadolinium enhancement.
Measured: Baseline and 6 months after beginning of the treatment in acromegalic patients
Change from baseline interstitial myocardial fibrosis at 6 months
Measured: Baseline and 6 months after beginning of the treatment in acromegalic patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startDec 2014
- Primary completion9 Jun 2017
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Philippe CHANSON, MD, PhDI, Principal investigator, AP-HP, Bicêtre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948322
- Sponsor's protocol ID
- P121004
- Acronym
- ACROCOEUR
- Status last verified
- Oct 2016
- First submitted
- 8 Dec 2015
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37549351