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A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04520646
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Zhaoyun Zhang, Huashan Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

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




Primary Outcome Measures :
  1. Left ventricular mass index [ Time Frame: 6 months ]
    the changes in left ventricular mass index by heart MRI



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04520646


Contacts
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Contact: Cuiyun Wu +86(21)52888045 mhe2004@263.net

Locations
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China, Shanghai
Huashan Hospital Recruiting
Shanghai, Shanghai, China, 200040
Contact: Min He, Doctor    +862152887027    mhe2004@263.net   
Principal Investigator: Zhaoyun Zhang, Professor         
Sponsors and Collaborators
Huashan Hospital
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Responsible Party: Zhaoyun Zhang, vice director of endocrine department, Huashan Hospital
ClinicalTrials.gov Identifier: NCT04520646    
Other Study ID Numbers: KY2020-849
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acromegaly
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs