Screening for Primary Aldosteronism in a Population of Patients With Hypertension

NCT03105531 | Completed

• 1 other identifier: Project 16-25
• Study Type: observational
• Target: 1,183
• Locations: 1 country
• Sites: 1

Brief Summary

Primary aldosteronism (PA) is an under-diagnosed cause of arterial hypertension. Cardiovascular morbidity and mortality in hypertension rises significantly for patients who have aldosterone overproduction when compared with those with primary hypertension and the same level of blod pressure elevation. The classical signs of PA such as severe hypertension and hypokalemia may be absent, why screening in defined risk groups has been recommended. Screening has not been systematically implemented in Sweden, probably due to expensive, time and effort-consuming clinical routine protocols and low awareness of the problem among clinicians. The prevalence of PA in patients with hypertension in Sweden has not been studied adequately, and few studies from Northern Europe have addressed the problem. The primary objective is to investigate prevalence of PA among patients with hypertension in primary care and to implement and assess optimal treatment. Discovered cases of PA will go through routine clinical work-up in order to distinguish the subtype of PA, which includes computed tomography of adrenals and adrenal vein sampling (AVS) in those willing and fit for surgical treatment. Treatment will be then chosen depending on the PA subtype. Those with unilateral disease who are willing and fit for surgery will be offered unilateral minimally invasive adrenalectomy. Patients who oppose or have contraindications to operative treatment, as well as patients with bilateral disease will be offered medical treatment with mineralocorticoid receptor antagonists (MRA). Study participants will be then followed up one year after surgery or initiation of specific medical treatment. Please se outcome measures for relevant description of those. Blood samples will be collected from patients with confirmed PA to be stored in a biobank for potential future genetical and biochemical studies. A subgroup of patients with PA will undergo adrenal-specific positron-emission tomography to assess the possibility to un-invasively diagnose and subtype PA.

Conditions

Primary Aldosteronism; Hypertension; Hypertension Secondary

Keywords

primary aldosteronism; hypertension; screening; secondary hypertension

Outcome Measures

Primary Outcomes (1)

• Prevalence estimates of primary aldosteronism (PA) and of PA subtypes in a Swedish population of primary care patients with arterial hypertension

  ARR - Aldosterone-Renin Ratio; i.v. - intravenous; NaCl - sodium chloride;

  For each patient, the time necessary to go through initial (sometimes repeated) screening with ARR, then (sometimes repeated) confirmation testing with i.v. NaCl-suppression test will be approximately 6 months

Secondary Outcomes (12)

• The proportion of screening-discovered patients with PA who could be offered surgical treatment - and who have accepted operation and have been unilaterally adrenalectomized.

  Considering work-up time and waiting time for planned surgery of this type it is realistic to assume minimal time frame of approximately 2 years

• Changes in clinical characteristics of hypertension and in antihypertensive treatment regimen still needed - one year after the diagnosis of primary aldosteronism had been stated and specific treatment applied.

  Evaluation of treatment effects is done at the follow-up patient contact one year after adrenal surgery or initiation of specific medical treatment - approximately 1,5 - 2 years after the first screening.

• Serum potassium level - one year after the diagnosis of primary aldosteronism had been stated and specific treatment applied.

  Evaluation is done at the follow-up patient contact one year after adrenal surgery or initiation of specific medical treatment - approximately 1,5 - 2 years after the first screening.

• Any potassium supplementation if still needed - one year after the diagnosis of primary aldosteronism.

  Evaluation is done at the follow-up patient contact one year after adrenal surgery or initiation of specific medical treatment - approximately 1,5 - 2 years after the first screening.

• Serum creatinine - one year after the diagnosis of primary aldosteronism.

  Evaluation is done at the follow-up patient contact one year after adrenal surgery or initiation of specific medical treatment - approximately 1,5 - 2 years after the first screening.

Eligibility Criteria

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

Study Population

An unselected population of primary care patients with hypertension

You may qualify if:

• participants must have Swedish personal number (that gives right to all kinds of necessary planned health care)

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala-Örebro Regional Research Council: collaborator

Study Sites (1)

Uppsala University, the Department of Surgical Sciences

Uppsala, Uppsla, 75236, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from patients with documented primary aldosteronism are going to be (with the patients informed consent) obtained to be stored in Uppsala Biobank for future scientific purposes.

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Per Hellman, PhD

  Uppsala University, The Department of Surgical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of the Department of Surgical Sciences, Uppsala University

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 10, 2017
• Study Start: April 7, 2017
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-12

Locations

SE (1)