Long-term Blood Pressure Outcome After Unilateral Adrenalectomy for Primary Hyperaldosteronism

Adrenalectomy; Status Clinical Trial

— Hyperaldo  

Official title:

Long-term Blood Pressure Outcome After Unilateral Adrenalectomy for Primary Hyperaldosteronism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648294
• Other study ID #: PI2017_843_0040
• Status: Completed
• Start date: December 1, 2013
• Est. completion date: January 31, 2017

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate long-term results of adrenalectomy for primary aldosteronism (PA) and to identify prognostic factors associated.

Exhaustive retrospective review of all consecutive patients undergoing adrenalectomy for PA between 2002 and 2013 in our department. All patients underwent preoperative: clinical evaluation (age, sex, height, weight, systolic and diastolic BP under treatment, identification of anti-hypertension treatment), biological evaluation (potassium, renin, aldosterone) and radiological evaluation (CT and/or MRI). Blood pressure was assessed postoperatively at 1 month, 1 year, then at the date of the latest news. The patients were classified into three categories: cured (no antihypertensive therapy in postoperative associated with strictly lower blood pressures of 140/90mmHg), improved (decreased number of drugs or number unchanged but with better blood pressure control), and refractory (no change in the number of drug and blood pressure, or deterioration of one or other of these two parameters).

Description:

To evaluate long-term results of adrenalectomy for primary aldosteronism (PA) and to identify prognostic factors associated.Exhaustive retrospective review of all consecutive patients undergoing adrenalectomy for PA between 2002 and 2013 in our department. All patients underwent preoperative: clinical evaluation (age, sex, height, weight, systolic and diastolic BP under treatment, identification of anti-hypertension treatment), biological evaluation (potassium, renin, aldosterone) and radiological evaluation (CT and/or MRI). Blood pressure was assessed postoperatively at 1 month, 1 year, then at the date of the latest news. The patients were classified into three categories: cured (no antihypertensive therapy in postoperative associated with strictly lower blood pressures of 140/90mmHg), improved (decreased number of drugs or number unchanged but with better blood pressure control), and refractory (no change in the number of drug and blood pressure, or deterioration of one or other of these two parameters).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients >25 years and <80 years patients undergoing adrenalectomy for PA

• All patients underwent preoperative: clinical evaluation (age, sex, height, weight, systolic and diastolic BP under treatment, identification of anti-hypertension treatment), biological evaluation (potassium, renin, aldosterone) and radiological evaluation (CT and/or MRI).

Exclusion Criteria:

• patients <25 years

• patients > 80 years

Related Conditions & MeSH terms

• Adrenalectomy; Status
• Hyperaldosteronism

Intervention

Other:
• adrenalectomy for primary addosteronism
All of the clinical and biological data were retrospectively compiled from the patient computerized record. The variables analyzed were: age, sex, body mass index (BMI), PAH discovery circumstances, pre- and postoperative systolic and diastolic blood pressure assessments, number of pre-hypertensive antihypertensive drug - and postoperatively, the laterality, the size and nature of the lesions, the operating time, the surgical technique used. The biological data evaluated were pre- and postoperative plasma and plasma creatinine, preoperative serum aldosterone concentrations, plasma renin activity, and preoperative aldosterone / renin ratio. Hypokalemia was defined as serum concentration below 3.5 mmol / L.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adrenalectomy for primary hyperaldosteronism	The objective of this study is to evaluate the course of the disease associated with long-term outcomes of adrenalectomy for the treatment of PAH, with a retrospective analysis of patient data!	1 year