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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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
Are there results?
None posted in the registry

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.

France1 site

  • AP-HP, Bicêtre Hospital

    Le Kremlin-Bicêtre, 94275

Other trials in France

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 :

  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.
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 groups in NCT02948322
Study groupRoleWhat they receive
OGTT, CMRI with gadolinium in patientsExperimentalPatients with acromegaly will be investigated
Receives: Device: CMRI; Drug: Gadolinium; Procedure: OGTT
OGTT, CMRI with gadolinium in volunteersActive comparatorAge-, 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.

  1. 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

  2. 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)

  1. 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

  2. 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

  3. Cardiac morphology will also be assessed CMRI

    Measured: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  1. First posted28 Oct 2016 (estimated)
  2. Study startDec 2014
  3. Primary completion9 Jun 2017
  4. Study completion28 Feb 2019

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

A study testing CMRI, Gadolinium and OGTT in people with Acromegaly, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial transverse relaxation time (T2), reflecting water content assessed by CMRI (time frame: Baseline in acromegalic patients; at the 1 day evaluation visit in healthy volunteers). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02948322, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.

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