Renal Denervation Therapy for Resistant Hypertension in T... | NCT01887067

Studies
Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus

NCT01887067

Sponsor

Pamela Youde Nethersole Eastern Hospital

Status

Terminated

Last Update Posted

Nov 18, 2022Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Hypertension, Resistant
Diabetes Mellitus
Renal Denervation Therapy

Interventions

Renal denervation therapy

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow recruitment and change in clinical evidence

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

May 30, 2022Actual

Completion Date

May 30, 2022Actual

First Submitted Date

Jun 24, 2013

First Submission Date that Met QC Criteria

Jun 25, 2013

First Posted Date

Jun 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2022

Last Update Posted Date

Nov 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Label	Type	Description	Intervention Names
Renal denervation therapy	Experimental		Procedure: Renal denervation therapy

Name	Type	Description	Arm Group Labels	Other Names
Renal denervation therapy	Procedure		Renal denervation therapy	Renal denervation using Symplicity® Catheter System™

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in office systolic & diastolic blood pressure from baseline to 6 months		6 months

Secondary Outcomes

Measure	Description	Time Frame
Change in office systolic and diastolic blood pressure up to 3 years		3 years
Change in insulin sensitivity	HOMA-IR index at baseline, 3-month and 12-month	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ranges from 18 to 70 years inclusive
Essential hypertension
Office Systolic BP (SBP) ≥ 150 mmHg or Diastolic BP (DBP) ≥ 90mmHg
3 or more anti-hypertensive medications of different classes, including a diuretic, or documented intolerance to multiple medications
Type 2 Diabetes Mellitus on oral hypoglycaemic agent (OHA)
2 functional kidneys; eGFR ≥ 45 mL/min/1.73m² (MDRD formula)
Suitable renal anatomy compatible with the endovascular denervation procedure

Exclusion Criteria:

Individual has renal artery anatomy that is ineligible for treatment including:
Patients with secondary hypertension
Myocardial infarction, unstable angina pectoris, cerebrovascular accident within 6 months
Patient with type 1 diabetes mellitus
Patient on insulin due to oral drug failure
Renovascular abnormalities (including severe renal artery stenosis, previous renal stenting or angioplasty, or known dual renal arteries)
Pregnancy
Patient with any implantable device incompatible with radiofrequency energy delivery
Hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous
Any serious medical condition, which in the opinion of the investigator, may limit the life expectancy of patients or adversely

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kin Lam Tsui, FRCP (Edin, Glasg)	Pamela Youde Nethersole Eastern Hospital	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided