Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Observational, Retrospective, Comparative Study to Investigate Differential Outcome on Cardiomyopathy Following Control of Acromegaly After Surgery or Somatostatin Analogues Given as First-Line Therapy
Brief Summary: A direct comparison between the results of surgery or somatostatin analogues (SSA) on cardiovascular complication in acromegaly has never been performed.

Our objective is to investigate whether first-line surgery or SSA have a different outcome on cardiomyopathy after 12 months. The design of the study is retrospective, comparative, non randomized, because of ethical problems.

Setting University Hospital. All patients treated with SSA \[either octreotide-LAR (10-40 mg/q28d), or lanreotide (30-120 mg/q28d); dosages up-titrated to control GH and IGF-I levels\] or operated on by transsphenoidal approach. For the purposes of this study only controlled patients will be included.

Measurements Primary outcome measures were changes in left ventricular mass index (LVMi), diastolic \[early to atrial mitral flow velocity (E/A)\] and systolic perform-ance \[LV ejection fraction (LVEF)\]. Secondary outcome measures were reduction of total/HDL-cholesterol ratio, as a cardiovascular (CV) risk parameter, improvement of glucose profile and pituitary function, as indirect causes of CV improvement.

Expected results: SSA and surgery groups should have similar results in terms of improvement of cardiomyopathy. However, recent data suggest that SSA reduce directly heart rate and cardiomyocytes performance: clinical implications of these evidences suggest that SSA will improve cardiovascular outcome more than surgery. Moreover, after surgery, replacement therapy already stabilised or of new onset, has never been considered so far in this setting.


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Octreotide Implant | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sandostatin LAR Depot | Intervention Type: DRUG; Name: Octreotide Implant; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Sandostatin LAR Depot; Assigned to Arm(s): 2
B: Arm Label: Pasireotide LAR; Type: EXPERIMENTAL; Interventions: Drug: Pasireotide | Arm Label: Octreotide LAR; Type: ACTIVE_COMPARATOR; Interventions: Drug: Octreotide | Intervention Type: DRUG; Name: Pasireotide; Assigned to Arm(s): Pasireotide LAR | Intervention Type: DRUG; Name: Octreotide; Assigned to Arm(s): Octreotide LAR
C: Arm Label: Pasireotide LAR 40 mg; Type: EXPERIMENTAL; Interventions: Drug: Pasireotide | Arm Label: Pasireotide LAR 60 mg; Type: EXPERIMENTAL; Interventions: Drug: Pasireotide | Arm Label: Control arm (octreotide or lanreotide); Type: ACTIVE_COMPARATOR; Interventions: Drug: octreotide LAR 30mg, Drug: lanreotide ATG 120mg | Intervention Type: DRUG; Name: Pasireotide; Assigned to Arm(s): Pasireotide LAR 40 mg, Pasireotide LAR 60 mg | Intervention Type: DRUG; Name: octreotide LAR 30mg; Assigned to Arm(s): Control arm (octreotide or lanreotide) | Intervention Type: DRUG; Name: lanreotide ATG 120mg; Assigned to Arm(s): Control arm (octreotide or lanreotide)
D: Arm Label: 1-SSA; Type: N/A; Interventions: N/A | Arm Label: 2-Surgery; Type: N/A; Interventions: N/A

Answer: D