Cardiac (CMRI) Assessment of Acromegaly

NCT02948322

Last updated date
Study Location
AP-HP, Bicêtre Hospital
Le Kremlin Bicêtre, , 94275, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acromegaly
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Cardiac (CMRI) Assessment of Acromegaly
Official Title  ICMJE Cardiac Structure and Function in Acromegalic Patients: A Cardiac Magnetic Resonance Imaging Study
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 :

  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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Acromegaly
Intervention  ICMJE
  • Device: CMRI
    Myocardial Imaging (CMRI) will be performed in patients (at baseline and 6 month after treatment) and healthy volunteers (baseline)
  • Drug: Gadolinium
    gadolinium injection will be performed during CMRI in patients and healthy volunteers.
    Other Name: Gadolinium injection
  • Procedure: OGTT
    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 Arms  ICMJE
  • Experimental: OGTT, CMRI with gadolinium in patients
    Patients with acromegaly will be investigated
    Interventions:
    • Device: CMRI
    • Drug: Gadolinium
    • Procedure: OGTT
  • Active Comparator: OGTT, CMRI with gadolinium in volunteers
    Age-, sex- and BMI-matched healthy volunteers will be investigated
    Interventions:
    • Device: CMRI
    • Drug: Gadolinium
    • Procedure: OGTT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2019)
28
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2016)
40
Actual Study Completion Date  ICMJE February 28, 2019
Actual Primary Completion Date June 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02948322
Other Study ID Numbers  ICMJE P121004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Philippe CHANSON, MD, PhDIAP-HP, Bicêtre Hospital
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP