NCT06568640Recruiting
Superselective Adrenal Arterial Embolization for Refractory Hypertension: A Proof-of-Concept Study
Evaluation and Exploration of the Safety and Efficacy of Superselective Adrenal Arterial Embolization in Patients With Essential Refractory Hypertension: A Proof-of-Concept Study
Source: ClinicalTrials.gov · Last updated 23 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 18 Aug 2024
- Start date
- 1 Aug 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- Second Affiliated Hospital of Nanchang University
- Diseases
- High blood pressure
- NCT number
- NCT06568640
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Aug 2024 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- Presence of other severe organic diseases that would make the patient unable to tolerate superselective adrenal arterial embolization;
- Severe allergy to contrast agents;
Lab values
- 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;
Other
- Pregnant women or those planning to conceive within the next year;
- Adrenal mass with a diameter exceeding 2 cm;
- Patients enrolled or planning to participate in other clinical studies that could impact the results of this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.