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NCT04520646 Clinical Trial

A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy

Acromegaly Clinical Trial

Official title:
A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04520646
Other study ID # KY2020-849
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date August 31, 2022

Study information
Verified date August 2020
Source Huashan Hospital
Contact Cuiyun Wu
Phone +86(21)52888045
Email mhe2004@263.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date August 31, 2022
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Empagliflozin
empagliflozin of 10mg/day is added on the basis of primary care

Locations
Country Name City State
China Huashan Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Left ventricular mass index the changes in left ventricular mass index by heart MRI 6 months
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