Cardiac (CMRI) Assessment of Acromegaly

NCT02948322 | Completed

• 1 other identifier: P121004
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromegaly

Keywords

Acromegaly,; water retention; myocardial fibrosis; left ventricular hypertrophy; left ventricular dysfunction

Outcome Measures

Primary Outcomes (2)

• Myocardial transverse relaxation time (T2), reflecting water content assessed by CMRI

  This outcome will be compared between patients and healthy volunteers.

  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

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

Secondary Outcomes (10)

• Dense myocardial fibrosis

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

• Interstitial myocardial fibrosis

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

• Cardiac morphology will also be assessed CMRI

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

• Function including Left Ventricular mass index will also be assessed CMRI

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

• Function including Left Auricular ejection fractions will also be assessed CMRI

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

Study Arms (2)

OGTT, CMRI with gadolinium in patients

EXPERIMENTAL

Patients with acromegaly will be investigated

Device: CMRI; Drug: Gadolinium; Procedure: OGTT

OGTT, CMRI with gadolinium in volunteers

ACTIVE COMPARATOR

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

Device: CMRI; Drug: Gadolinium; Procedure: OGTT

Interventions

CMRI DEVICE

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

OGTT, CMRI with gadolinium in patients; OGTT, CMRI with gadolinium in volunteers

Gadolinium DRUG

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

Also known as: Gadolinium injection

OGTT, CMRI with gadolinium in patients; OGTT, CMRI with gadolinium in volunteers

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.

OGTT, CMRI with gadolinium in patients; OGTT, CMRI with gadolinium in volunteers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Pfizer: collaborator

Study Sites (1)

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

Location

Related Publications (1)

• 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.

  PMID: 37549351 DERIVED

MeSH Terms

Conditions

Acromegaly; Hypertrophy, Left Ventricular; Ventricular Dysfunction, Left

Interventions

Gadolinium; Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Philippe CHANSON, MD, PhDI

  AP-HP, Bicêtre Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: October 28, 2016
• Study Start: December 1, 2014
• Primary Completion: June 9, 2017
• Study Completion: February 28, 2019
• Last Updated: May 15, 2019

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)