Short- and Long-term Outcomes of Adrenalectomy for Primary Aldosteronism

NCT06192810 | Completed

• 1 other identifier: 157714
• Study Type: observational
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

The proposed study is this. Short- and long-term outcomes of adrenalectomy for Primary Aldosteronism (PA) in a single centre. PA is a relatively common problem and considers as the commonest cause of secondary hypertension and can be successfully treated by adrenalectomy. The investigators aim to gather clinical data routinely collected on participants with primary aldosteronism pre-operatively and post-operatively for a short and long term follow up.

Conditions

Primary Aldosteronism

Outcome Measures

Primary Outcomes (2)

• Short- and long-term assessment of clinical improvement in systolic and diastolic blood pressure

  Short- and long-term clinical changes for the following parameter: -Systolic and diastolic blood pressure measured in mmHg

  3 months for short term and 5 years for long term

• Short- and long-term assessment of clinical improvement in number of antihypertensive medications in participants

  Short- and long-term clinical changes for the following parameter: -Number of antihypertensive medications

  3 months for short term and 5 years for long term

Secondary Outcomes (4)

• Short- and long-term assessment of biochemical improvement in serum potassium level in participants

  3 months for short term and 5 years for long term

• Short- and long-term assessment of biochemical improvement in serum Aldosterone level in participants

  3 months for short term and 5 years for long term

• Short- and long-term assessment of biochemical improvement in serum Renin level in participants

  3 months for short term and 5 years for long term

• Short- and long-term assessment of biochemical improvement in serum Aldosterone/Renin ratio (ARR) (pmol/nmol/L) level in participants

  3 months for short term and 5 years for long term

Interventions

Laparoscopic/open adrenalectomy PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed with primary aldosteronism and underwent surgical treatment

You may qualify if:

• Patient underwent adrenalectomy as a management of primary aldosteronism
• Patient available for short term and long term follow up

You may not qualify if:

• medically treated patients
• not available for follow up

Sponsors & Collaborators

• University College London Hospitals: lead

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator and clinical fellow

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: January 5, 2024
• Study Start: January 1, 1998
• Primary Completion: December 31, 2022
• Study Completion: May 1, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share