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

21. februar 2022 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

400

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Sichuan
      • Chengdu, Sichuan, Kina, 610500
        • Yaqiong Zhou
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical outcomes-Change from Baseline Systolic Blood Pressure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
biochemical outcomes-Change from Baseline hypokalaemia and the aldosterone/plasma renin
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

First Affiliated Hospital of Chengdu Medical College

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. april 2022

Primær fullføring (Forventet)

1. januar 2025

Studiet fullført (Forventet)

1. januar 2025

Datoer for studieregistrering

Først innsendt

9. januar 2022

Først innsendt som oppfylte QC-kriteriene

21. februar 2022

Først lagt ut (Faktiske)

2. mars 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. mars 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. februar 2022

Sist bekreftet

1. februar 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SAAE-001

Plan for individuelle deltakerdata (IPD)

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