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

21 febbraio 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

400

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Cina
    • Sichuan
      • Chengdu, Sichuan, Cina, 610500
        • Yaqiong Zhou
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Clinical outcomes-Change from Baseline Systolic Blood Pressure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
biochemical outcomes-Change from Baseline hypokalaemia and the aldosterone/plasma renin
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

First Affiliated Hospital of Chengdu Medical College

Investigatori

  • Cattedra di studio: Yanqiu Yang, First Affiliated Hospital of Chengdu Medical College

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 aprile 2022

Completamento primario (Anticipato)

1 gennaio 2025

Completamento dello studio (Anticipato)

1 gennaio 2025

Date di iscrizione allo studio

Primo inviato

9 gennaio 2022

Primo inviato che soddisfa i criteri di controllo qualità

21 febbraio 2022

Primo Inserito (Effettivo)

2 marzo 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 marzo 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 febbraio 2022

Ultimo verificato

1 febbraio 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SAAE-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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