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

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ClinicalTrials.gov Identifier: NCT03648294
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief 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).


Condition or disease Intervention/treatment
Adrenalectomy; Status 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).

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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Long-term Blood Pressure Outcome After Unilateral Adrenalectomy for Primary Hyperaldosteronism
Actual Study Start Date : December 1, 2013
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Adrenalectomy for primary hyperaldosteronism [ Time Frame: 1 year ]
    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!



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648294


Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Fabien Saint, MD, PhD CHU AMIENS

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03648294    
Other Study ID Numbers: PI2017_843_0040
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
blood pressure
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases