RDN-HT

JRCT ID: jRCTs042180047

Registered date:14/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Resistant hypertension
• Date of first enrollment: 01/07/2013
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Assessing safety and effectivess of renal sympathetic denervation in Japanese patients by the method of muscle sympathetic nerve activity

Outcome(s)

Primary Outcome

1)Safety during perioperative period and chronic phase after the operation(evaluated with eGFR and imaging study)
2)Onset or progression of cardiovascular disease

Secondary Outcome

1)Safety of the technique in the operation
2)Systolic blood pressure one year after the operation
3)Sympathetic nerve activity after the operartion(evaluated with muscle sympathetic nerve activity and blood hormone such as catecholamine)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both
• Include criteria: Patients whose systolic pressure is beyond 160mmHg in spite of taking more than 3 kinds of antihypertensive drug(patients whose systolic pressure is beyond 150mmHg, if he is a diabetic)

Exclude criteria

1)Anatomical anomaly of renal artery inappropriate for the operation
2)Estimated glomerular filtration rate is less than 45mL/min
3)History of myocardial infarction, angina pectoris, or cerebrovascular accident within 6 month
4)Type1 diabetes mellitus
5)Secondary Hypertension

Related Information

• Primary Sponsor: Takamura Masayuki