Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome: A Prospective, National and Multicentric Study
Prevalence of sleep apnea syndrome in patients with acromegaly is about 70%. It seems that comorbidities of arterial hypertension or type 2 diabetes are more severe in patients with acromegaly and sleep apnea syndrome. Besides sleep apnea syndrome associated to acromegaly gives rise to few symptoms, that explains it is under diagnosed. The mechanisms of the association are based on maxillofacial modifications linked to acromegaly, a thickening of soft tissues with deposits of glyco-aminoglycanes but probably also because of the associated obesity, of the potential existence of a goiter and a muscular dystrophy of the dilatative muscles of the pharynx. At present, no study clearly documented prevalence of acromegaly in a diagnostic consultation for sleep apnea syndrome.
NCT02789696 — Sleep Apnea Syndrome
Status: Completed
http://inclinicaltrials.com/sleep-apnea-syndrome/NCT02789696/
A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands
Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref). The objective of this study was to compare the efficacy, safety, and patient reported outcomes (PROs) between oral octreotide capsules and injectable somatostatin receptor ligands (SRLs).
NCT02685709 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT02685709/
Efficacy and Safety of Pasireotide Long Acting Release (LAR) in Combination With Weekly Pegvisomant in Previously Controlled Acromegaly Patients on Combination Treatment of Long-Acting Somatostatin Analogues and Weekly Pegvisomant
The objective of this study is to assess the efficacy of Pasireotide Long Acting Release (LAR) alone and in combination with weekly Pegvisomant (PEGV) in acromegaIy patients previously controlled with combination treatment of long-acting Somatostatin analogs (LA-SSAs) and PEGV.
NCT02668172 — Acromegaly
Status: Active, not recruiting
http://inclinicaltrials.com/acromegaly/NCT02668172/
Study on New Insights in Remodeling of Endocrine Cardiomyopathies: ASsessmentt of Intramyocardial, Molecular and NeUroendocrine Parameters in Response to Chronic Inhibition of Cyclic GMP Phosphodiesterase 5A in AcroMegaly
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.
NCT02611336 — Acromegaly Cardiomyopathy
Status: Completed
http://inclinicaltrials.com/acromegaly-cardiomyopathy/NCT02611336/
International Multicentre Validation Study of SAGIT® Instrument in Acromegaly
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.
NCT02539927 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT02539927/
Assessment of Airway in Patients With Acromegaly Undergoing Surgery: Predicting Successful Tracheal Intubation
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.
NCT02403414 — Acromegaly
Status: Recruiting
http://inclinicaltrials.com/acromegaly/NCT02403414/
A Prospective, Non-interventional, Observational, Multi-centre Study to Document QoL of Subjects With Acromegaly Under Lanreotide Autogel® Treatment.
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).
NCT02396966 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT02396966/
The Prevalence of Acromegaly in the Sleep Apnoea Clinic
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.
NCT02371057 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT02371057/
A Phase IIIb Multicenter, Open-label, Single Arm Study to Evaluate the Efficacy and Safety of Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues
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.
NCT02354508 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT02354508/
LateR-Ac Study: Late Effects of Radiosurgery on Acromegaly Study
Transsphenoidal surgery is the first-line treatment of acromegaly. Adjunctive radiotherapy can be necessary when surgery is ineffective to avoid a prolonged medical treatment. Several studies reported long-term extra-pituitary side-effects of conventional radiotherapy. However, none has evaluated potential side-effects induced by Gamma Knife radiosurgery, a highly precise stereotactic technique, that has been used as an effective treatment of acromegaly. Aims of the study: To determine potential long-term (superior to 10 years) extra-pituitary side-effects of Gamma Knife radiosurgery in patients treated for Acromegaly. Methods: Transversal exposed/unexposed study. Exposed patients have been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion, whereas unexposed patients have been treated by somatostatin analogs after unsuccessful surgery for at least 10 years before inclusion. 80 Patients (40 patients/group) will be evaluated in terms of cognitive dysfunction, quality of life, secondary tumor, stroke, pituitary deficits and growth hormone control of hypersecretion. Recruitment is planned to last for 2 years. Expected results: We should be able to determine whether Gamma Knife radiosurgery is a long-term safe technique. This result might modify the management and follow-up of patients with acromegaly unsuccessfully treated by surgery.
NCT02296216 — Acromegaly
Status: Completed
http://inclinicaltrials.com/acromegaly/NCT02296216/