薬物不耐性患者における耐火性高血圧または高血圧の治療のために、超音波神経アブレーション装置と組み合わせて使用される超音波神経アブレーションカテーテルの有効性と安全性 (ModulationHTN2)
耐火性高血圧または薬物 - 不耐性高血圧の治療のための超音波腎除神経装置と組み合わせた超音波腎除神経カテーテルの有効性と安全性を評価するための前向き、多施設、無作為化制御臨床試験
Prospective, multicenter, randomized, controlled, blinded, and superiority - designed; The target population undergoes a screening treatment with prescribed medications for at least 4 weeks. Eligible subjects are randomly assigned to the experimental group and the control group at a ratio of 2:1. The experimental group is treated with the ultrasound nerve ablation catheter and the ultrasound nerve ablation device of Shenzhen Maiwei Medical Technology Co., Ltd., while the control group only undergoes renal arteriography (regarded as a sham operation). Within 6 months after the operation, both groups continue to receive antihypertensive drug treatment with the dosage and types specified during the screening period. The subjects are kept blinded during the study. The relative change values of the average 24 - hour ambulatory systolic blood pressure from the baseline at 6 months after the operation are compared between the two groups.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Guangzhou、中国
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age between 18 and 70 years old (calculated based on the date of starting standardized medication).
- After treatment with at least two types of antihypertensive drugs for 4 weeks or more, the clinic systolic blood pressure is ≥140 mmHg and ≤180 mmHg, and the average 24 - hour ambulatory systolic blood pressure is ≥130 mmHg (or the daytime ambulatory systolic blood pressure is ≥135 mmHg).
- Resting heart rate ≥70 beats per minute without taking beta - blockers (this criterion does not apply to patients taking beta - blockers).
- The subject agrees to participate in this clinical trial, complies with the follow - up required by the trial protocol, and has voluntarily signed the informed consent form
Exclusion Criteria:
- CTA, MRA, or DSA examination shows that the shape and structure of the unilateral or bilateral renal arteries are not suitable for ablation surgery (renal artery stenosis exceeding 50%, renal artery aneurysm, fibromuscular dysplasia of the renal artery, or the diameter of the main renal artery is less than 3 mm).
- Having only one kidney or having received a kidney transplant.
- Having a history of renal artery interventional treatment or renal denervation surgery.
- Suffering from any condition that may affect the accuracy of blood pressure measurement, such as the upper arm diameter being too large relative to the cuff.
- Secondary hypertension (excluding apnea syndrome).
- Glomerular filtration rate (eGFR) < 45 mL/min/1.73m² (MDRD formula).
- Having a history of hospitalization due to hypertensive crisis within one year before randomization for enrollment.
- Suffering from type 1 diabetes.
- Suffering from primary pulmonary hypertension.
- Being allergic to contrast agents.
- Severe cardiac valve stenosis.
- Cardiac insufficiency (NYHA class III - IV).
- Hyperthyroidism or hypothyroidism.
- Requiring mechanical ventilation for assisted breathing (except for nocturnal respiratory support for treating sleep apnea).
- Acute or severe systemic infection.
- Having an implantable cardioverter - defibrillator (ICD) or pacemaker.
- Having obvious symptoms of active peptic ulcer (such as abdominal pain, nausea, vomiting, regurgitation, etc.).
- Having obvious bleeding tendency and hematological diseases.
- Having a history of surgery or trauma requiring hospitalization within 30 days before randomization for enrollment.
- Having a cardiovascular event (stable or unstable angina, myocardial infarction) or cerebrovascular event (stroke, cerebrovascular accident, transient ischemic attack) within 6 months before randomization for enrollment.
- Pregnant, lactating women, or women planning to become pregnant during the study period.
- Currently participating in other clinical trials of drugs or medical devices.
- Other reasons that the investigator deems inappropriate for participation in this study
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：超音波腎除神経
|
Treat with an ultrasound nerve ablation catheter and an ultrasound nerve ablation device |
|
偽コンパレータ：腎動脈造影
|
Treat with an ultrasound nerve ablation catheter and an ultrasound nerve ablation device |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The average change value of 24 - hour ambulatory systolic blood pressure (ASBP) relative to the baseline
時間枠：Six months after surgery
|
The average change value of 24 - hour ambulatory systolic blood pressure (ASBP) relative to the baseline at 6 months after surgery |
Six months after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The change values of clinic systolic blood pressure and diastolic blood pressure relative to the baseline
時間枠：3 months and 6 months after surgery
|
The changes in clinic systolic and diastolic blood pressures relative to the baseline at 3 months and 6 months after surgery |
3 months and 6 months after surgery
|
|
The attainment rate of clinic diastolic blood pressure
時間枠：3 months and 6 months after surgery
|
The attainment rate of clinic systolic blood pressure (90 mmHg ≤ SBP < 140 mmHg) at 3 months and 6 months after surgery The attainment rate of clinic systolic blood pressure (90 mmHg ≤ SBP < 140 mmHg) at 3 months and 6 months after surgery The attainment rate of clinic systolic blood pressure (90 mmHg ≤ SBP < 140 mmHg) at 3 months and 6 months after surgery |
3 months and 6 months after surgery
|
|
The average change value of 24 - hour ambulatory diastolic blood pressure relative to the baseline
時間枠：3 months and 6 months after surgery
|
The average change values of 24 - hour ambulatory diastolic blood pressure relative to the baseline at 3 months and 6 months after surgery |
3 months and 6 months after surgery
|
|
The average change value of 24 - hour ambulatory systolic blood pressure relative to the baseline
時間枠：Three months after surgery
|
The average change value of 24 - hour ambulatory systolic blood pressure relative to the baseline at 3 months after surgery |
Three months after surgery
|
|
The proportion of patients with a reduction in clinic systolic blood pressure of ≥5 mmHg, 10 mmHg, 15 mmHg, and 20 mmHg
時間枠：3 months and 6 months after surgery
|
The proportion of patients with a reduction in clinic systolic blood pressure of ≥ 5 mmHg, 10 mmHg, 15 mmHg, and 20 mmHg at 3 months and 6 months after surgery |
3 months and 6 months after surgery
|
|
Changes in the drug composite index of the types and dosages of antihypertensive medications
時間枠：Six months after surgery
|
Changes in the drug composite index of the types and dosages of antihypertensive drugs 6 months after surgery |
Six months after surgery
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。