| CTRI Number |
CTRI/2012/05/002681 [Registered on: 22/05/2012] Trial Registered Prospectively |
| Last Modified On: |
23/06/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Autonomic Regulation Therapy for treatment of Heart Failure. |
|
Scientific Title of Study
|
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study |
| Trial Acronym |
(ANTHEM-HF) |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| Protocol No. C-01 Version 2.0 Dated 29 Oct 2012 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Atul Gupta |
| Designation |
Medical Monitor |
| Affiliation |
Max Neeman International |
| Address |
Max Neeman International
Address Line 2: Max House, 1, Dr. Jha Marg, Okhla Phase-III
New Delhi
South
DELHI
110020
India |
| Phone |
91-9717287654 |
| Fax |
91-11-41001945 |
| Email |
Atul.Gupta@neemanasia.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shariq Anwar |
| Designation |
Head Operations |
| Affiliation |
Max Neeman Medical International Ltd. |
| Address |
Max House, 1st Floor, 1, Dr. Jha Marg, Okhla Phase III
New Delhi - 110 020, India
South
DELHI
110020
India |
| Phone |
91-9810979215 |
| Fax |
91-11-40548168 |
| Email |
Shariq.Anwar@maxneeman.com |
|
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Source of Monetary or Material Support
|
| Cyberonics, Inc.
100 Cyberonics Blvd.
Houston, Texas
77058 USA. |
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Primary Sponsor
|
| Name |
Cyberonics Inc |
| Address |
100 Cyberonics Blvd.
Houston, Texas
77058 USA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
|
| Name |
Address |
| Max Neeman International |
Max House,1st Floor
1 Dr. Jha Marg, Okhla III
New Delhi- 110020
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrBhagvathula Kutumba Srinivasa Sastry |
Care Hospitals |
Exhibition Grounds Road, Nampally, Pin Code – 500001
Hyderabad
ANDHRA PRADESH |
91-9849599888
bksshastri@hotmail.com |
| Dr Ajay Naik |
CIMS Hospital Pvt. Ltd. |
Nr. Shukan Mall,
Off. Science City Road,
Sola, Pin COde -380060
Ahmadabad
GUJARAT |
91-9825082666
ajay.naik@cims.me |
| Dr Shireesh Prabhakar Sathe |
Deenannath Mangeshkar Hospital |
Erandwane, Near Mhatre Bridge, Pin Code - 411004, India
Pune
MAHARASHTRA |
91-9822053216
shireesh.sathe@gmail.com |
| Dr Rajendra Kumar Premchand |
Krishna Institute of Medical science |
#1-8-31/1, Minister Road, Secunderabad, Pin Code - 500003, India
Hyderabad
ANDHRA PRADESH |
91-9848029443
kumarpre@hotmail.com |
| Dr Ulhas M Pandurangi |
Madras Medical Mission |
4-A, Dr. J. J. Nagar, Mogappair, Chennai-600037
Chennai
TAMIL NADU |
91-9841273868
epulhas@gmail.com |
| Dr Naresh Trehan |
Medanta- The Medicity |
Sector - 38, Pin Code - 122001
Gurgaon
HARYANA |
91-9971644444
naresh.trehan@medanta.org |
| Dr Ravi Kishore |
Narayana Hridayalaya Hospital |
258/A, Bommasandra, Industrial Area, Anekal Taluk, Pin Code - 560099,India
Bangalore
KARNATAKA |
91-9980030155
ravikishoreag@yahoo.co.in |
| Dr kamal Sharma |
Sanjivani Super Speciality Hospitals Pvt. Ltd. |
Cardiology Department, OPD - 4, Ground Floor,
1, Uday Park Society, Near Sunrise Park, Vastrapur, Ahmedabad-380015
Ahmadabad
GUJARAT |
91-9426020154
kamalsharma1975@rediffmail.com |
| Dr Shantanu Sengupta |
Sengupta Hospital |
Raninagar Square, Pin Code - 440033
Nagpur
MAHARASHTRA |
91-9923190925
senguptasp@gmail.com |
| Dr Rufino Monteiro |
Vintage Hospital Premises |
Building No- 2, Near Caculo Mall, Panaji
North Goa
GOA |
91-9822100328
rufino@sify.com |
| Dr Rajasekhar V |
Yashoda Hospital |
Behind Harihara kalabhavan, S.P. Road, Secunderabad 500003, India
Hyderabad
ANDHRA PRADESH |
91-9949825483
dr.rajasekharvarada@gmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee of Care Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Care Foundation, Care Hospital, Road No.1,Banjara Hills, Hyderabad-500034 |
Approved |
| Institutional Ethics Committee, Lata Mangeshkar Medical Foundations Deenanath Mangeshkar Hospital and Research Centre, Erandwane, Near Mhatre Bridge, Pune 411004 |
Approved |
| Institutional Ethics Committee, Madras Medical Mission, 4-A, Dr. J. J. Nagar, Mogappair, Chennai-600037 |
Approved |
| Institutional Ethics Committee, Yashoda Group of Hospital Hyderabad. Yashoda Hospital, Behind Harihara kalabhavan |
Approved |
| KIMS Intuitional Ethics Committee, #1-8-31/1, Minister Road, Secunderabad Institutional Ethics Committee, Yashoda Group of Hospital Hyderabad.500003,Hyderabad |
Approved |
| Medanta Independent Ethics Committee, Sector 38, Gurgaon, Haryana |
Approved |
| Nagpur Independent Ethics Committee 303, NIT Lay out, Trimurti Nagar, Nagpur, Nagpur, 440010 |
Approved |
| Narayana Hrudayalaya Medical Ethics Committee, Narayana Hrudalaya Hospital, Bangalore 560099 |
Approved |
| Sanjivani Hospitals Ethics Committee 1, Uday Park Society, Nr. Sunrise Park, Vastrapur, Ahmedabad-380015 |
Approved |
| Vintage Institutional Ethics Committee, Office c/o: Vintage Hospital and Medical Research Centre Pvt Ltd, Caculo Enclave, St.Inez, Panaji, Goa 403001, India |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Heart Failure , |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator Agent not used in this study
|
Comparator Agent not used in this study
|
| Intervention |
Implantable VNS therapy system
|
Patients with symptomatic heart failure will undergo 6 months of Intermittent therapeutic vagus nerve stimulation.
The device being studied includes the Implantable Pulse Generator (Model 103) which is implanted in pectoral region and a VNS Therapy lead (Model 304) which is attached to the cervical vagus nerve. The device is turned on two weeks after implant and the therapy is provided for 6 months. The device will provide Intermittent therapeutic vagus nerve stimulation throughout the therapy period.
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Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients enrolled in the study must meet all of the following criteria:
1. Age 18 or above
2. Willing and capable of providing informed consent
3. Capable of participating in all testing associated with this clinical investigation
4. Prescribed to optimal pharmacologic therapy for at least 1 month and stable beta blocker therapy for at least 3 months
5. Stable symptomatic heart failure NYHA class II/III
6. Left ventricular ejection fraction (EF) ≤ 40%
7. Left ventricular end diastolic diameter (LVEDD) ≥ 50 mm and < 80 mm
8. QRS width < 130 ms
9. Physically capable and willing to perform repeated 6-minute walk tests associated with the study, and a baseline distance of between 150 and 425 meters. Symptoms limiting the duration of the 6 minute walk test must be due to heart failure alone. |
|
| ExclusionCriteria |
| Details |
Patients who meet any of the following criteria are not eligible to be enrolled in the study:
1. Patients who have been hospitalized for heart failure and who required the use of HF IV therapy in the past 30 days
2. Patients unable to tolerate anesthesia required for implant
3. Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack in the past 90 days
4. Patients with chronic atrial fibrillation (lasting more than 1 week or requiring cardioversion or pharmacologic conversion) in the past 180 days.
5. Coronary Artery Bypass Surgery (CABG), valve replacement or repair, aortic surgery or PCI) in the past 90 days or anticipated in the next 180 days
6. Patients whose primary cause of heart failure is mitral or aortic valve disease, with a severe classification
7. Patients with cardiac pacemakers, and pacemaker indicated patients
8. Patients whose heart failure is due to congenital heart disease
9. Patients who are on an organ transplant list or expected to have an organ transplant within 6 months
10. Patients who have received inotropic therapy in the past 60 days11. Patients who have had amiodarone therapy initiated in the past 60 days with a maintenance dose of over 200 mg daily
12. Patients actively treated for sleep apnea or sleep disordered breathing with therapies to maintain airway patency with or without oxygen supplementation
13. Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
14. Patients on or indicated for renal dialysis
15. Patients with diabetes (type I or type II) that is being medically treated for autonomic or sensory neuropathy, or measured hemoglobin A1c (HbA1c) above 8.0% in the past 60 days.
16. Patients with hypotension (systolic blood pressure below 80 mmHg)
17. Patient with active peptic ulcer disease or history of upper GI bleeding, or ulcer within 6 months
18. Patients with asthma, history of severe COPD (e.g., FEV1 1.5 L) severe restrictive lung disease or oxygen dependence.
19. 1st degree AV block with PR interval 240 msec, 2nd or 3rd degree AV block
20. Patients with a life expectancy of less than 12 months per physician judgment
21. Patients involved in any concurrent clinical investigation
22. Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding
23. Patients with a prior cardiac transplant
24. Patients with congenital or acquired long QT syndrome.
25. Patients with documented recorded or suspected vasovagal syncope or vasodepressor syncope.
26. Patients who have undergone treatment by an investigational drug or device in the past 90 days
27. Patients with a prior vagotomy
28. Patients with prior or existing vagal nerve stimulation treatment
29. Patients who have a cardiac resynchronization therapy (CRT) device, or are scheduled for CRT in the next 6 months
30. Patients with locally implanted semi/permanent devices such as vascular catheters, etc.
31. Patients with previous neck surgery and resultant scar formation that interferes with the ability to implant the study system
32. Patients with known recurrent nerve paralysis33. Patients with untreated hypothyroidism or hyperthyroidism
34. Patients who have undergone radiotherapy for thyroid disease/cancer
35. Patients who have existing or prior tracheotomy
36. Patients with severe vertebral cervical disease and limited mobility in the neck; includes those that frequently wear a brace
37. Patients with carotid murmur/vascular bruit/carotid artery lesion
38. Patients with known/suspected vascular malformation in carotid/vertebral circulatory bed
39. Patients who are likely to need an MRI of the neck area because of previous medical conditions
40. Patients who are likely to need shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy. |
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
The primary safety endpoint will be the incidence of procedure and device-related complications.
The primary efficacy endpoint is ECHO assessment of left ventricular End systolic and diastolic volumes.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life questionnaire |
3,6 months |
| NYHA Class |
1,3 and 6 months |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
10/07/2012 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
None as Yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Patients with symptomatic heart failure will undergo 6 months of Intermittent therapeutic vagus nerve stimulation.
Study Hypothesis: To improve cardiac functions and reduce symptom expressions |