A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy

NCT ID: NCT04520646

Last Updated: 2020-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acromegaly Cardiomyopathies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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empagliflozin

empagliflozin is added on the basis of the original treatment

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

empagliflozin of 10mg/day is added on the basis of primary care

Interventions

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Empagliflozin

empagliflozin of 10mg/day is added on the basis of primary care

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoyun Zhang

vice director of endocrine department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Cuiyun Wu

Role: CONTACT

+86(21)52888045

Facility Contacts

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Min He, Doctor

Role: primary

+862152887027

Other Identifiers

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KY2020-849

Identifier Type: -

Identifier Source: org_study_id

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