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Acromegaly clinical trials

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NCT ID: NCT02611336 Completed - Clinical trials for Acromegaly Cardiomyopathy

Endocrine Cardiomyopathy: Response to Cyclic GMP PDE5 Inhibitors in Acromegaly Cardiomyopathy

SUM
Start date: July 2016
Phase: Phase 2
Study type: Interventional

Pathophysiology of acromegaly cardiomyopathy is yet unclear and a specific treatment have not been indicated. It was already demonstrated the positive impact of phosphodiesterase type 5A (PDE5A) inhibition in several models of cardiomyopathy and in a model of endocrine cardiomyopathy due to type 2 diabetes mellitus. In this patients with diabetic cardiomyopathy it was demonstrated an improvement in cardiac kinetic, geometry and performance parameters and reduction of the ambulatory measurement of waist circumference. This represents the first study that evaluate heart remodeling and performance changes and metabolic/immunological/molecular parameters after 5-months of Tadalafil 20 mg in Acromegaly cardiomyopathy. The proposed research will test whether phosphodiesterase 5A inhibition could become a new target for antiremodeling drugs and to discover molecular pathways affected by this class of drugs and a network of circulating markers (miRNA) for the early diagnosis of acromegaly cardiomyopathy. We hypothesize that: - the signal molecules cGMP and cAMP could underlie the hypertrophic/profibrotic triggers related to this model of endocrine cardiomyopathy and that chronic inhibition of PDE5, activating cGMP signaling pathways, could improve cardiac remodeling due to acromegaly - PDE5 inhibition could have a role in lipolytic regulation; - neuroendocrine (e.g. natriuretic peptides) and metabolic markers and chemokines (e.g. MCP-1, TGF-ß) might relate with left ventricular (LV) remodeling in Acromegaly; - there are neuroendocrine (e.g. natriuretic peptides), metabolic markers and chemokines (e.g. MCP-1, TGF-ß) related to cardiac disease in Acromegaly; - miRNA expression [miR-208a, 499, 1, 133, 126, 29, 233, 222, 4454] might relate with LV remodeling in Acromegaly.

NCT ID: NCT02539927 Completed - Acromegaly Clinical Trials

Validation Study of the SAGIT® Instrument in Acromegaly

SAGIT
Start date: July 2015
Phase:
Study type: Observational

Patients will be treated in accordance with the standard medical practice of the hospital where they have been recruited during their participation in this study. No additional assessments or tests will be required. SAGIT® is a new instrument developed by a group of acromegaly experts to help practicing endocrinologists to manage acromegalic patients and disease activity in their clinical practice and define acromegaly staging. It reports 5 elements: Signs and symptoms - S; Associated comorbidities - A; Growth hormone (GH) concentration - G; Insulin-like growth factor 1(IGF-1) concentration -I; Tumour size- T. The instrument has been pre evaluated during a qualitative pilot study. The purpose of the validation study is to define and validate the scoring of the SAGIT® instrument.

NCT ID: NCT02493517 Completed - Acromegaly Clinical Trials

Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly

LANTERN
Start date: October 2014
Phase: Phase 3
Study type: Interventional

The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg with lanreotide 40mg PR in subjects with active acromegaly.

NCT ID: NCT02427295 Recruiting - Acromegaly Clinical Trials

Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues

acromegaly
Start date: March 2014
Phase: Phase 4
Study type: Interventional

Long-term (up to 3 years) clinical and hormonal outcomes in acromegalic patients with treated surgery with or without long acting somatostatin analogues.

NCT ID: NCT02403414 Recruiting - Acromegaly Clinical Trials

Assessment of Airway in Patients With Acromegaly for Predicting Successful Tracheal Intubation

Start date: March 2015
Phase: N/A
Study type: Observational

Acromegaly is associated with increased risk of difficult intubation and its management. The overall incidence of difficult intubation in patients suffering from acromegaly is four to five times more than those without acromegaly.The difficult intubation scenario in these patients can be managed by various methods ranging from awake fiberoptic intubation to tracheostomy. Difficult tracheal intubation accounts for 17% of respiratory-related injuries and results in significant morbidity and mortality in general population. In patients with acromegaly, inability to mask ventilate or intubate can lead to 28% of all anesthesia related deaths. Therefore, the need and importance of airway assessment in patients with acromegaly cannot be overemphasized. Various tests of airway assessment have to be used to assess difficult airway and tracheal intubation in acromegalics. The investigators aim to assess the various tests of airway assessment affecting the outcome of patients with acromegaly undergoing pituitary surgery and identify which was best suited.

NCT ID: NCT02396966 Completed - Acromegaly Clinical Trials

Quality of Life (QoL) in Subjects With Acromegaly Under Lanreotide Autogel® Treatment.

ACRO QLQ
Start date: December 2014
Phase:
Study type: Observational

The purpose of the protocol is to evaluate and describe QoL, in the population of Polish acromegalic patients treated with Lanreotide Autogel® 120 mg during the 24 months (long term observation).

NCT ID: NCT02396953 Completed - Acromegaly Clinical Trials

Study to Determine the Maximum Tolerated Dose, Safety and Tolerability of a Single Dose of Lanreotide Prolonged Release Formulation (PRF) in Subjects With Acromegaly

Start date: March 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The objectives of the protocol is to determine the maximum tolerated dose and to investigate the pharmacokinetics of a single dose of lanreotide PRF in subjects with acromegaly.

NCT ID: NCT02371057 Completed - Acromegaly Clinical Trials

Acromegaly & Sleep Apnoea

Start date: November 24, 2014
Phase:
Study type: Observational

Estimates of the prevalence of acromegaly, a condition resulting from excess growth hormone secretion, are as high as 1:1000. If detected late acromegaly increases the risk of joint destruction, heart disease, sleep apnoea, high blood pressure, diabetes, and polyps in the colon. To have a greater effect on long-term outcomes this disease needs to be detected early. By screening a 'high risk' population (sleep apnoea clinic) the investigators may be able to detect these patients earlier and prevent late complications of the disease. At LTHT the referral pathway for new referrals to the sleep apnoea clinic involves initial attendance to pick up a pulse oximeter to wear overnight to measure oxygen levels. These readings show approximately 1:4 patients displays evidence of significant obstructive sleep apnoea to warrant referral to the treatment group for continuous positive airway pressure (CPAP), weight management, and occasionally mandibular adjustment. Patients attending the sleep apnoea clinic either as new referral or for review will be asked to participate in the proposed study. The study is cross-sectional in design incorporating two sub-populations within the sleep apnoea clinic. The first cohort comprises patients under follow-up known to have sleep apnoea, and the second cohort those patients prospectively attending the sleep apnoea clinic for assessment. If after an explanation of the study they agree to participate blood will be taken for assessment of IGF-I and they will be asked to complete a simple questionnaire. The aim will to be to screen 1000 consecutive patients. The questionnaire will incorporate five simple questions to be completed with a 'yes' or 'no' answer. Where IGF-I levels are elevated patients will be investigated further for the possibility of acromegaly. The presence of biochemically proven acromegaly will be used to determine if the simple question has sufficient sensitivity to use as a screening tool.

NCT ID: NCT02354508 Completed - Acromegaly Clinical Trials

Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues

Start date: March 31, 2015
Phase: Phase 3
Study type: Interventional

This is a phase IIIb multicenter, open-label; single arm study to evaluate the efficacy and safety of pasireotide LAR 40 mg and 60 mg in patients with inadequately controlled acromegaly with maximal approved doses of first generation somatostatin analogues. The study will enroll inadequately controlled patients by high doses (maximal approved) of first-generation somatostatin analogues given for at least 3 months. Patients will receive pasireotide LAR 40 mg or 60 mg during the 36 week core study phase. Patients who have completed all visits of core phase and have completed all the assessments at the core phase completion visit can move into the 32-week extension phase. Patients can continue with study treatment until pasireotide LAR is commercially available and reimbursed in their respective country or until the end of the extension phase whichever occurs first.

NCT ID: NCT02299089 Completed - Clinical trials for Neuroendocrine Tumors

Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)

Start date: January 2015
Phase: Phase 2
Study type: Interventional

This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid symptoms.