Back to resultsA Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy
Primary Purpose
Acromegaly, Cardiomyopathies
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Empagliflozin
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly
Eligibility Criteria
Inclusion Criteria:
- patients with pituitary GH adenomas confirmed by surgery
active acromegalic patients although treated with surgery,radiation therapy and somatostatin analogs
Exclusion Criteria:
- patients with contraindications to empagliflozin pregnant patients patients with poor control of hypertension(SBP>150mmHg or DBP>95mmHg patients with contraindications to MRI
Sites / Locations
- Huashan HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
empagliflozin
Arm Description
empagliflozin is added on the basis of the original treatment
Outcomes
Primary Outcome Measures
Left ventricular mass index
the changes in left ventricular mass index by heart MRI
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04520646
Brief Title
A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy
Official Title
A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Acromegaly is a disease characterized by excess growth hormone(GH) and insulin like growth factor(IGF)-1. Pituitary GH secreting adenoma is the major cause of acromegaly. Acromegalic cardiomyopathy is one of the leading causes of death in acromegalic patients. No efficient medicine is available for acromegalic cardiomyopathy until now and there were limited studies. Empagliflozin is proved to decrease the risk of heart failure in diabetic patients and independent of blood glucose control. We planed to evaluate the structure of heart by MRI before and after 6 months treatment with empagliflozin in acromegalic patients to investigate the effect of empagliflozin on acromegalic cardiomyopathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly, Cardiomyopathies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
empagliflozin
Arm Type
Experimental
Arm Description
empagliflozin is added on the basis of the original treatment
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Intervention Description
empagliflozin of 10mg/day is added on the basis of primary care
Primary Outcome Measure Information:
Title
Left ventricular mass index
Description
the changes in left ventricular mass index by heart MRI
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with pituitary GH adenomas confirmed by surgery
active acromegalic patients although treated with surgery,radiation therapy and somatostatin analogs
Exclusion Criteria:
patients with contraindications to empagliflozin pregnant patients patients with poor control of hypertension(SBP>150mmHg or DBP>95mmHg patients with contraindications to MRI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cuiyun Wu
Phone
+86(21)52888045
Email
mhe2004@263.net
Facility Information:
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min He, Doctor
Phone
+862152887027
Email
mhe2004@263.net
First Name & Middle Initial & Last Name & Degree
Zhaoyun Zhang, Professor
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy
We'll reach out to this number within 24 hrs