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

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).

Study Overview

• Status: Completed
• Conditions: Adrenalectomy; Status
• Intervention / Treatment: Other: adrenalectomy for primary addosteronism

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 43

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Between 2002 and 2013, the investigators evaluated all patients receiving adrenalectomy and extracted data on PAH patients. The diagnosis was made on the presence of hypertension (all stages combined), an autonomous hyperproduction of aldosterone and sometimes hypokalemia (n = 32). HTA was defined, in accordance with the recommendations of the Haute Autorité de Santé and the French Society of Arterial Hypertension (blood pressure greater than or equal to 140/90 mmHg)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2013
• Primary Completion (ACTUAL): January 31, 2017
• Study Completion (ACTUAL): January 31, 2017

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (ACTUAL): August 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 24, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: blood pressure
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hyperaldosteronism
• Other Study ID Numbers: PI2017_843_0040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No