| CTRI Number |
CTRI/2013/09/003943 [Registered on: 02/09/2013] Trial Registered Retrospectively |
| Last Modified On: |
16/01/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate efficacy and safety of renal denervation in the treatment of uncontrolled hypertension |
|
Scientific Title of Study
|
Single-arm Study of Symplicityâ„¢ Renal Denervation System in Patients with Uncontrolled HyperTensioN in India
HTN-India
|
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 2 April 2013, Version 1C, 10054637DOC |
Protocol Number |
| NCT01632943 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Seth |
| Designation |
Chairman -Cardiovascular Sciences & Chief Cardiologist |
| Affiliation |
Escorts Heart Institute & Research Center |
| Address |
Escorts Heart Institute & Research Center, Ohkla Road, New Delhi
Escorts Heart Institute & Research Center, Ohkla Road, New Delhi
New Delhi
DELHI
110025
India |
| Phone |
911126825001 |
| Fax |
911126825112 |
| Email |
ashok.seth@fortishealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Seth |
| Designation |
Chairman -Cardiovascular Sciences & Chief Cardiologist |
| Affiliation |
Escorts Heart Institute & Research Center |
| Address |
Escorts Heart Institute & Research Center, Ohkla Road, New Delhi
Escorts Heart Institute & Research Center, Ohkla Road, New Delhi
New Delhi
DELHI
110025
India |
| Phone |
911126825001 |
| Fax |
911126825112 |
| Email |
ashok.seth@fortishealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Seth |
| Designation |
Chairman -Cardiovascular Sciences & Chief Cardiologist |
| Affiliation |
Escorts Heart Institute & Research Center |
| Address |
Escorts Heart Institute & Research Center, Ohkla Road, New Delhi
Escorts Heart Institute & Research Center, Ohkla Road, New Delhi
New Delhi
DELHI
110025
India |
| Phone |
911126825001 |
| Fax |
911126825112 |
| Email |
ashok.seth@fortishealthcare.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
India Medtronic Pvt Ltd |
| Address |
Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri East - 400093 |
| Type of Sponsor |
Other [Medical Device ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinay Kumar Bahl |
All India Institute of Medical Sciences |
Department of Cardiology, Ansari Nagar, New Delhi
New Delhi
DELHI |
919871053131
vkbahl2002@yahoo.com |
| Dr Tejas Patel |
Apex Heart Institute |
Department of Cardiology, Block No. G 2K, Mondeal Business Park, Nr. Gurudwara, SC Road, Tajtej, Ahemdabad
Ahmadabad
GUJARAT |
917966115600
tejaspatel@tcvsgroup.org |
| Dr Rajeev Menon |
Care Hospital |
Department of Cardiology, Banjara Hills, Road No. 01, Hyderabad - 500034
Hyderabad
ANDHRA PRADESH |
040-30418888
rmenon73@gmail.com |
| Dr Keyur Parikh |
Care Institute of Medical Sciences |
Department of Cardiology, Opp. Panchamrut Bunglow, Near Shukan Mall, Sola, Off Science City Road
Ahmadabad
GUJARAT |
917927712771
917927712777
keyur.parikh@cims.me |
| Dr Ashok Seth |
Fortis Escorts Heart Institute |
Department of Cardiology, Okhla Road, New Delhi - 110025
New Delhi
DELHI |
01126825000
ashok.seth@fortishealthcare.com |
| Dr Upendra Kaul |
Fortis Flt Lt Rajan Dhall Hospital |
Department of Cardiology, B-1, Aruna Asaf Ali Marg, Sector B, Vasant Kunj New Delhi, Delhi 110070
New Delhi
DELHI |
01142776222
ukaul@vsnl.com |
| Dr Sanjay Tyagi |
Govind Vallabh Pant Hospital |
Jawaharlal Nehru Marg, New Delhi,
Delhi 110002
New Delhi
DELHI |
9891356668
drsanjaytyagi@yahoo.com |
| Dr Balbir Singh |
Medanta - The Medicity |
Department of Cardiology, Sector - 38, Gurgaon - 122001
Gurgaon
HARYANA |
01244141414
Balbir.Singh@Medanta.org |
| Dr Purshottam Lal |
Metro Hospital & Heart Institute |
Department of Cardiology, Metro Hospital & Heart Institute, X-1 Sector 12, Noida, Uttar Pradesh 201301
Ghaziabad
UTTAR PRADESH |
9871429423
p_lal@hotmail.com |
| Dr Harikrishnan Pillai |
Sree Chitra Tirunal Institute for Medical Sciences & Technology |
Thiruvananthapuram - 695 011, Kerala
Thiruvananthapuram
KERALA |
0471-2443152
drhari@sctinst.ac.in |
| Dr Durjati Prasad Sinha |
The Institute of Post Graduate Medical Education & Research & Seth Sukhlal Karnani Memorial Hopsital |
244, Acharya Jagadish Chandra Bose Road,
Police Station - Bhowanipore,
Kolkata-700020
Kolkata
WEST BENGAL |
91-33-22041100
drdpsihna@gmail.com |
| Dr Hermohander Singh Isser |
Vardhman Mahavir Medical College & Safdarjung Hospital |
Ministry of Health & F.W., Govt . of India. NEW DELHI - 110 029
New Delhi
DELHI |
91-9899128399
drhsisser@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Ethical Committee of Maulana Azad Medical college & Govind Vallabh Pant Hospital |
Approved |
| Ethics Committee - Medanta - The Medicity |
Approved |
| Ethics Committee - Metro Hospital |
Approved |
| Ethics Committee at Safdurjung Hospital |
Submittted/Under Review |
| Ethics Committee of The Care Institute of Medical Sciences |
Approved |
| Ethics Committee, AIIMS |
Approved |
| FACTS Foundation Institutional Ethics Committee - Continental Hospital |
Submittted/Under Review |
| Institutional Ethical Committee, Care Hospital |
Approved |
| Institutional ethics committee of Institute of Post graduate Medical Education |
Approved |
| Institutional Ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) |
Submittted/Under Review |
| Sujalam Ethics Committee |
Approved |
| The Independent Ethics Committee, Fortis Escorts Hospital |
Approved |
| The Independent Ethics Committee, Fortis Flt. Lt. Rajan Dhall Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Medtronic Symplicity renal denervation system |
This is the first of its kind and therefore no comparator agent is available. This study is to evaluate efficacy and safety of renal denervation using the Symplicity Catheter in the treatment of uncontrolled hypertension |
| Comparator Agent |
None |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Individual is more than or equal to 18 and ≤ 80 years old at time of treatment.
2. Individual is receiving a stable medication regimen including 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic that is expected to be maintained without changes for at least 6 months.
3. Individual has an office systolic blood pressure (SBP) of greater than or equal to 160 mmHg based on an average of 3 blood pressure readings measured at screening visits
4. Individual or legally authorized representative agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
|
|
| ExclusionCriteria |
| Details |
1. Individual has renal artery anatomy that is ineligible for treatment including:
a. Main renal arteries with 4 mm diameter or with 20 mm treatable length (i.e., free of visible anatomic abnormality or atheroma).
b. Multiple renal arteries where the main renal artery is estimated to supply 75% of the kidney.
c. Renal artery stenosis (50%) or renal artery aneurysm in either renal artery.
d. A history of prior renal artery intervention including balloon angioplasty or stenting.
2. Individual has an estimated glomerular filtration rate (eGFR) of
45mL/min/1.73m2, using the MDRD calculation.
3. Individual has had 1 in-patient hospitalization for a hypertensive crisis within the past year.
4. Individual has type 1 diabetes mellitus.
5. Individual has had ≥ 1 episode(s) of orthostatic hypotension (reduction of SBP of ≥20 mmHg or DBP of ≥10 mmHg within 3 minutes of standing) coupled with symptoms within the past year or during the screening process.
6. Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
7. Individual has primary pulmonary hypertension.
8. Individual has known secondary causes of hypertension, such as untreated pheochromocytoma, Cushing’s Disease, coarctation of the aorta, hyperthyroidism, or hyperparathyroidism.
9. Individual has experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
10. Individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months.
11. Individual has a condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol-specified automatic blood pressure monitor (e.g., arm diameter too large for the cuff, arrhythmia that interferes with automatic monitor’s pulse sensing and prohibits an accurate measurement).
12. Individual has severe cardiac valve stenosis for which, in the opinion of the Investigator, a significant reduction of blood pressure is contraindicated.
13. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (e.g., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia).
14. Individual is pregnant, nursing or planning to be pregnant. [Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to angiography.]
15. Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
16. Individual is currently enrolled in another investigational drug or device trial. For the purposes of this protocol, participants involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy: Change in Office Systolic Blood Pressure from baseline to 6 months post-procedure |
6 months post-procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety: Incidence of Major Adverse Events (MAE), BP reduction, Chronic Safety –at 6 months post-denervation |
6 months post-procedure |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
02/10/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Publications and presentations referring to HTN-India will be coordinated by Medtronic to allow the use of all available data. The details will be provided shortly |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is to evaluate efficacy and safety of renal denervation in the treatment of uncontrolled hypertension.
In this study adults with uncontrolled hypertension [systolic blood pressure ≥ 160 mmHg despite 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic] who meet inclusion/exclusion criteria will be enrolled. Subjects in the intent-to-treat population will be followed from enrollment through 6 months ±14 days for the effectiveness and safety endpoints |