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NCT Number: NCT06568640

Superselective Adrenal Arterial Embolization for Refractory Hypertension: A Proof-of-Concept Study

The subjects of this study were patients with essential refractory hypertension. The purpose of this study is to evaluate the safety and efficacy of superselective adrenal arterial embolization (SAAE) in patients with primary refractory hypertension and to explore the possibility of SAAE in patients with primary refractory hypertension.After the subject completes the SAAE, an 8-week follow-up will be conducted to assess the safety and effectiveness of the SAAE.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Location status: Recruiting

Location contact

Yifei Dong, doctorate

CONTACT

[email protected]

+8613576007061

About this study

The subjects of this study were patients with essential refractory hypertension. The study design was a single-center, open-label, self-controlled, single-arm, prospective study. The purpose of this study is to evaluate the safety and efficacy of superselective adrenal arterial embolization (SAAE) in patients with primary refractory hypertension and to explore the possibility of SAAE in patients with primary refractory hypertension.After the subject completes the SAAE, an 8-week follow-up will be conducted to assess the safety and effectiveness of the SAAE.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years, no gender restrictions;
  • Primary refractory hypertension: Taking three antihypertensive drugs, including a - diuretic, with an average office systolic blood pressure ≥150 mmHg measured three times;
  • Duration of hypertension greater than 6 months;
  • Standing plasma aldosterone and renin activity not below the lower limit of the unit's reference range;
  • Signed informed consent form.

Exclusion criteria

  • Morning cortisol level < 4.3 µg/dL; estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m²; serum potassium level > 5.5 mmol/L;
  • Type 1 diabetes, uncontrolled hyperthyroidism, malignant arrhythmias, malignant tumors, decompensated heart failure, severe liver dysfunction, severe hematological diseases, severe obstructive sleep apnea syndrome, history of myocardial infarction, syncope, cerebral hemorrhage, or cerebral infarction within the past 3 months;
  • Pregnant women or those planning to conceive within the next year;
  • Presence of other severe organic diseases that would make the patient unable to tolerate superselective adrenal arterial embolization;
  • Adrenal mass with a diameter exceeding 2 cm;
  • Severe allergy to contrast agents;
  • Patients enrolled or planning to participate in other clinical studies that could impact the results of this study.

Treatment and study plan

Superselective adrenal arterial embolization

Procedure

Superselective adrenal arterial embolization is an operation to inject embolic agent into adrenal artery through catheter to embolize part of adrenal gland, so as to reduce the secretion of adrenal hormone and reduce blood pressure.

Other names: Adrenal artery ablation, catheter-based adrenal ablation, Transcatheter Arterial Ablation, Transarterial embolization, percutaneous adrenal arterial embolization, selective adrenal artery embolization

Primary outcomes

  1. 24-hour mean systolic blood pressure

    Time frame: 8 weeks after SAAE

    ambulatory blood pressure monitoring

Secondary outcomes

  1. Proportion of patients with non-refractory hypertension

    Time frame: 8 weeks after SAAE

    Describe how many patients are converted from refractory hypertension to non-refractory hypertension

  2. 24-hour mean diastolic blood pressure

    Time frame: 8 weeks after SAAE

    ambulatory blood pressure monitoring

  3. Safety monitoring:Procedure-related complications

    Time frame: up to 8 weeks

    Procedure-related complications include but are not limited to the following: transient arrhythmia during the SAAE procedure, incidence of hypertensive encephalopathy; post-procedure complications such as pleural effusion, brachial artery pseudoaneurysm, brachial artery thrombosis, pancreatitis, and contrast-induced nephropathy.

  4. Safety monitoring:Adrenal-related hormones

    Time frame: 8 weeks after SAAE

    Plasma aldosterone concentration, plasma renin activity, plasma cortisol concentration, corticotropin-releasing hormone level, blood catecholamine levels, sex hormone levels.

  5. Safety monitoring:Kidney function

    Time frame: 8 weeks after SAAE

    Estimated Glomerular Filtration Rate

  6. Safety monitoring:Plasma electrolyte levels

    Time frame: 8 weeks after SAAE

    Plasma potassium

Other outcomes

  1. Daytime average systolic blood pressure

    Time frame: 8 weeks after SAAE

    Daytime average systolic blood pressure

  2. Daytime average diastolic blood pressure

    Time frame: 8 weeks after SAAE

    Daytime average diastolic blood pressure

  3. Nighttime average systolic blood pressure

    Time frame: 8 weeks after SAAE

    Nighttime average systolic blood pressure

  4. Nighttime average diastolic blood pressure

    Time frame: 8 weeks after SAAE

    Nighttime average diastolic blood pressure

Study contacts

Contact information is provided by the study sponsor or research team.

Yifei the second affiliated hospital of Nanchang university, Doctor

CONTACT

[email protected]

(0791)86209562

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Nanchang University

Other

Registry information

Official study title

Evaluation and Exploration of the Safety and Efficacy of Superselective Adrenal Arterial Embolization in Patients With Essential Refractory Hypertension: A Proof-of-Concept Study

Acronym: SAAE-RH

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 23, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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