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Completed

NCT Number: NCT02948322

Cardiac (CMRI) Assessment of Acromegaly

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CMRI

Device

Myocardial Imaging (CMRI) will be performed in patients (at baseline and 6 month after treatment) and healthy volunteers (baseline)

Gadolinium

Drug

gadolinium injection will be performed during CMRI in patients and healthy volunteers.

Other names: Gadolinium injection

OGTT

Procedure

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 outcomes

  1. 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

    This outcome will be compared between patients and healthy volunteers.

  2. 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 outcomes

  1. Dense myocardial fibrosis

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

    The dense myocardial fibrosis will be depicted by late gadolinium enhancement.

  2. Interstitial myocardial fibrosis

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

    Interstitial myocardial fibrosis will be quantified by T1 measurements before and after gadolinium injection.

  3. Cardiac morphology will also be assessed CMRI

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

  9. Change from baseline Dense myocardial fibrosis at 6 months

    Time frame: Baseline and 6 months after beginning of the treatment in acromegalic patients

    "The dense myocardial fibrosis will be depicted by late gadolinium enhancement.

  10. Change from baseline interstitial myocardial fibrosis at 6 months

    Time frame: Baseline and 6 months after beginning of the treatment in acromegalic patients

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Pfizer

Registry information

Official study title

Cardiac Structure and Function in Acromegalic Patients: A Cardiac Magnetic Resonance Imaging Study

Acronym: ACROCOEUR

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Oct 28, 2016
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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