ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Boston, Massachusetts
- Le Kremlin Bicêtre,
- Ghent,
- Edmonton, Alberta
- Edmonton, Alberta
- Halifax, Nova Scotia
- Toronto, Ontario
- Montreal, Quebec
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 :
| |||
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 |
| |||
Study Arms ICMJE |
| |||
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 | 28 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
Responsible Party | Assistance Publique - Hôpitaux de Paris | |||
Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
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 |