NCT04520646

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

12 months

First QC Date

August 17, 2020

Last Update Submit

August 17, 2020

Conditions

AcromegalyCardiomyopathies

Outcome Measures

Primary Outcomes (1)

  • Left ventricular mass index

    the changes in left ventricular mass index by heart MRI

    6 months

Study Arms (1)

empagliflozin

EXPERIMENTAL

empagliflozin is added on the basis of the original treatment

Drug: Empagliflozin

Interventions

EmpagliflozinDRUG

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

empagliflozin

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with pituitary GH adenomas confirmed by surgery
  • active acromegalic patients although treated with surgery,radiation therapy and somatostatin analogs

You may not qualify if:

  • patients with contraindications to empagliflozin pregnant patients patients with poor control of hypertension(SBP\>150mmHg or DBP\>95mmHg patients with contraindications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

AcromegalyCardiomyopathies

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Cuiyun Wu

CONTACT

+86(21)52888045mhe2004@263.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice director of endocrine department

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 20, 2020

Study Start

September 1, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2022

Last Updated

August 20, 2020

Record last verified: 2020-08

Locations

CN(1)