Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT06344650 - Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
Active, not recruiting NCT02092129 - Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly. N/A
Completed NCT02012127 - Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
Active, not recruiting NCT01265121 - Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism. N/A
Terminated NCT00765323 - Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly Phase 3
Completed NCT00500227 - Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
Completed NCT00531908 - Physiopathology of Sodium Retention in Acromegaly N/A
Completed NCT01278342 - Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Phase 4
Active, not recruiting NCT01809808 - A Prospective Study of Outcome After Therapy for Acromegaly
Completed NCT00145405 - Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction Phase 4
Completed NCT00210457 - Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Phase 3
Recruiting NCT05401084 - Diet in the Management of Acromegaly N/A
Recruiting NCT00005100 - Measurement of Outcome of Surgical Treatment in Patients With Acromegaly N/A
Completed NCT00521300 - Preoperative Octreotide Treatment of Acromegaly Phase 4
Completed NCT03548415 - Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands Phase 2
Not yet recruiting NCT04066569 - Reproducibility and Utility of OGTT in Acromegaly N/A
Not yet recruiting NCT05298891 - Hypoproteic Diet in Acromegaly N/A
Not yet recruiting NCT04529356 - The TMS Treatment for Postoperative Headache in GH Tumor N/A
Active, not recruiting NCT03252353 - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Phase 3
Completed NCT02934399 - Dynamic Hormone Diagnostics in Endocrine Disease