The Long-term Effect of SAAE and Medical Treatment for Primary Aldosteronism

February 21, 2022 updated by: First Affiliated Hospital of Chengdu Medical College

The Long-term Effect of Superselective Adrenal Arterial Embolization and Medical Treatment for Primary Aldosteronism on Cardiorenovascular Protection, Blood Pressure, and the Endocrinological Profile.

In this prospective controlled trial, we aim to determine whether superselective adrenal artery embolization is superior to medical treatment for patients with PA who refuse surgery for medication. Patients age 18 to 75 years with hypertension will be screened for the presence of PA according to Endocrine Society Clinical Practice Guidelines. Patients with confirmed PA are counseled on the treatment option, including adrenalectomy. Those who opt to enroll in the study choice either SAAE or spironolactone (20-60mg daily) therapy (medical group). In both groups, if office blood pressure exceeds 140/90mmHg, amlodipine and terazosin will sequentially be added to the initial therapy form month 1 to year 3. The primary endpoint is the change in blood pressure, and the secondary end point is the change in biochemical outcomes. The Primary Aldosteronism Surgical Outcome criteria are used to classify clinical and biochemical outcomes as complete, partial, or absent success.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Primary aldosteronism (PA) is the main cause of secondary hypertension, affecting 5%-15% of the general hypertensive population. Early diagnosis and treatment are of crucial importance because patients with PA are more susceptible to cardiovascular morbidity and mortality than primary hypertensive patients. Traditional treatments such as medication with mineralocorticoid receptor antagonists and adrenalectomy have some limitations. Over the past decade, superselective adrenal artery embolization (SAAE) has been used to treat PA, but their efficacies have not been compared with medication-controlled studies. Recent study found that SAAE is an effective and safe treatment for patients with PA. In this prospective controlled trial, we aim to determine whether this procedure is superior to medical treatment for patients with PA who refuse surgery for medication.

Patients age 18 to 75 years with hypertension will be screened for the presence of PA according to Endocrine Society Clinical Practice Guidelines. Adrenal computed tomography will be performed in all patients. Patients willing to participate in the study also will undergo adrenal venous sampling (AVS) Serum aldosterone and renin levels are measured by chemiluminescence immunoassay. Patients with confirmed PA are counseled on the treatment option, including adrenalectomy. Those who opt to enroll in the study choice either SAAE or spironolactone (20-60mg daily) therapy (medical group). In both groups, if office blood pressure exceeds 140/90mmHg, amlodipine and terazosin will sequentially be added to the initial therapy form month 1 to year 3. The primary endpoint is the change in blood pressure, and the secondary end point is the change in biochemical outcomes. The Primary Aldosteronism Surgical Outcome Criteria are used to classify clinical and biochemical outcomes as complete, partial, or absent success.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hypertensive patients were willing to participate and then hospitalized for further evaluation. Antihypertensive medications that affect the renin-angiotensin-aldosterone system were stopped for two weeks, diuretics and MRA were withdrawn for at least 4 weeks before ARR testing. Hypertensive patients were prescribed with verapamil and/or terazosin based on Endocrine Society Clinical Practice Guideline. Patients with positive aldosterone-to-renin ratio underwent one of the following confirmatory tests: saline infusion test or captopril inhibition test. Adrenal CT scan and adrenal venous sampling (AVS) were performed for subtype classification of the PA. The PA patients were counseled on the various treatment options, including surgery, medications, and adrenal artery ablation.

Description

Inclusion Criteria:

  • Clinical diagnosis of PA
  • They refused medication treatment due to intolerance of side effects
  • They had lateralization by adrenal venous sampling (AVS), and refused the adrenalectomy

Exclusion Criteria:

  • History of serious contrast agent allergy
  • Complication with severe liver diseases
  • History of myocardial infarction and stent implantation within the past 3 months
  • Renal insufficiency, with serum creatinine >176 umo/L
  • Pregnancy or lactation
  • History of participation in another clinical trial in the past 3 months
  • Any serious comorbidity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
SAAE group
Patients who were diagnosed with primary aldosteronism choice SAAE at our institution
MRA group
Patients who were diagnosed with primary aldosteronism choice medical treatment(mineralocorticoid receptor antagonists, MRA)) at our institution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes-Change from Baseline Systolic Blood Pressure
Time Frame: at 12 months
Complete clinical success is defined as normotension without the aid of antihypertensive medication. Partial clinical success is defined as the same blood pressure as before treatment with less antihypertensive medication or a reduction in blood pressure with either the same amount or less antihypertensive medication. Absent clinical success is defined as unchanged or increased blood pressure with either the same amount or an increase in antihypertensive medication
at 12 months
Clinical outcomes-Change from Baseline Systolic Blood Pressure
Time Frame: at 24 months
Complete clinical success is defined as normotension without the aid of antihypertensive medication. Partial clinical success is defined as the same blood pressure as before treatment with less antihypertensive medication or a reduction in blood pressure with either the same amount or less antihypertensive medication. Absent clinical success is defined as unchanged or increased blood pressure with either the same amount or an increase in antihypertensive medication
at 24 months
Clinical outcomes-Change from Baseline Systolic Blood Pressure
Time Frame: at 36 months
Complete clinical success is defined as normotension without the aid of antihypertensive medication. Partial clinical success is defined as the same blood pressure as before treatment with less antihypertensive medication or a reduction in blood pressure with either the same amount or less antihypertensive medication. Absent clinical success is defined as unchanged or increased blood pressure with either the same amount or an increase in antihypertensive medication
at 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biochemical outcomes-Change from Baseline hypokalaemia and the aldosterone/plasma renin
Time Frame: at 12 months
Complete biochemical success is defined as correction of hypokalaemia (if present pretreatment) and normalization of the aldosterone/plasma renin(ARR); in patients with a raised ARR after treatment, aldosterone secretion should be suppressed in a confirmatory test. Partial biochemical success is defined as correction of hypokalaemia (if present pre-treatment) and a raised ARR with one or both of the following (compared with pre-treatment): ≥50% decrease in baseline plasma aldosterone concentration; or abnormal but improved post-treatment confirmatory test result. Absent biochemical success is defined as persistent hypokalaemia (if present pre-treatment) or persistent raised ARR, or both, with failure to suppress aldosterone secretion with a post-treatment confirmatory test
at 12 months
biochemical outcomes-Change from Baseline hypokalaemia and the aldosterone/plasma renin
Time Frame: at 24 months
Complete biochemical success is defined as correction of hypokalaemia (if present pretreatment) and normalization of the aldosterone/plasma renin(ARR); in patients with a raised ARR after treatment, aldosterone secretion should be suppressed in a confirmatory test. Partial biochemical success is defined as correction of hypokalaemia (if present pre-treatment) and a raised ARR with one or both of the following (compared with pre-treatment): ≥50% decrease in baseline plasma aldosterone concentration; or abnormal but improved post-treatment confirmatory test result. Absent biochemical success is defined as persistent hypokalaemia (if present pre-treatment) or persistent raised ARR, or both, with failure to suppress aldosterone secretion with a post-treatment confirmatory test
at 24 months
biochemical outcomes-Change from Baseline hypokalaemia and the aldosterone/plasma renin
Time Frame: at 36 months
Complete biochemical success is defined as correction of hypokalaemia (if present pretreatment) and normalization of the aldosterone/plasma renin(ARR); in patients with a raised ARR after treatment, aldosterone secretion should be suppressed in a confirmatory test. Partial biochemical success is defined as correction of hypokalaemia (if present pre-treatment) and a raised ARR with one or both of the following (compared with pre-treatment): ≥50% decrease in baseline plasma aldosterone concentration; or abnormal but improved post-treatment confirmatory test result. Absent biochemical success is defined as persistent hypokalaemia (if present pre-treatment) or persistent raised ARR, or both, with failure to suppress aldosterone secretion with a post-treatment confirmatory test
at 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Chengdu Medical College

Investigators

  • Study Chair: Yanqiu Yang, First Affiliated Hospital of Chengdu Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

January 9, 2022

First Submitted That Met QC Criteria

February 21, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 21, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAAE-001

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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