A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy

• Sponsor: Huashan Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04520646
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acromegaly; Cardiomyopathies	Drug: Empagliflozin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy
• Anticipated Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Aug 31, 2021
• Anticipated Study Completion Date: Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: empagliflozin empagliflozin is added on the basis of the original treatment	Drug: Empagliflozin; empagliflozin of 10mg/day is added on the basis of primary care

Outcome Measures

Primary Outcome Measures

1. Left ventricular mass index [6 months]

   the changes in left ventricular mass index by heart MRI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huashan Hospital	Shanghai	Shanghai	China	200040

Sponsors and Collaborators

• Huashan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhaoyun Zhang, vice director of endocrine department, Huashan Hospital
• ClinicalTrials.gov Identifier: NCT04520646
• Other Study ID Numbers: KY2020-849
• First Posted: Aug 20, 2020
• Last Update Posted: Aug 20, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acromegaly; Cardiomyopathies; Empagliflozin

Study Results

No Results Posted as of Aug 20, 2020