| CTRI Number |
CTRI/2020/02/023116 [Registered on: 05/02/2020] Trial Registered Prospectively |
| Last Modified On: |
23/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and efficacy of Sacubitril/Valsartan in blood pressure control of dialysis patients |
|
Scientific Title of Study
|
Safety and efficacy of Sacubitril/Valsartan in control of resistant hypertension in CKD 5D patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mehakinder Singh |
| Designation |
Senior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
DM Senior Resident, Department of Nephrology, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
00918628817113 |
| Fax |
|
| Email |
mehakinder.singh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Rathi |
| Designation |
Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Professor, Department of Nephrology, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
00919216721287 |
| Fax |
|
| Email |
drmanishrathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Rathi |
| Designation |
Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Professor, Department of Nephrology, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
00919216721287 |
| Fax |
|
| Email |
drmanishrathi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research |
| Address |
PGIMER, Sector 12, Chandigarh-160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mehakinder Singh Senior Resident |
PGIMER Chandigarh |
Department of Nephrology, Block C, Ground Floor, Nehru Hospital
Chandigarh
CHANDIGARH |
00918628817113
mehakinder.singh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC PGIMER Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No comparator. Single arm trial. |
No comparator. Single arm trial. |
| Intervention |
Sacubitril/Valsartan |
Sacubitril/Valsartan is a angiotensin receptor blocker-neprilysin inhibitor combination.
On trial entry, patients will first receive Sacubitril/Valsartan 50mg once daily orally. In case by end of 4 weeks of treatment, office SBP remains more than 140 mm Hg or DBP more than 90 mm Hg the dose of Sacubitril/Valsartan will be doubled to 50 mg twice daily unless adverse effects preclude a dose increase. The total duration of therapy shall be 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients declared as CKD 5D
Aged >18 years
Resistant hypertension
Non oliguric
Definitions
CKD 5D- defined as hemodialysis dependence since last 3 months prior to screening
Resistant hypertension- defined as uncontrolled hypertension SBP > 140 mm Hg or DBP >90 mm Hg despite use of 3 or more antihypertensive drugs including a diuretic
Non oliguric- defined as urine output more than 200 ml per day
|
|
| ExclusionCriteria |
| Details |
Serum potassium >5.5 mg/dl
Not giving consent
History of angioedema
History of intolerance to ACE-inhibitors/ ARBs
Associated heart failure with reduced ejection fraction
Alanine aminotransferase or Aspartate aminotransferase >2 times the upper limit of the normal range
Not willing for thrice a week hemodialysis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The safety of Sacubitril/Valsartan in CKD 5D patients |
at the end of week-1/2/4/8/12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study efficacy of Sacubitril/Valsartan in control of resistant hypertension in CKD 5D patients |
at the end of 3 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/02/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective interventional study aimed to study the safety and efficacy of Sacubitril/Valsartan combination therapy in control of resistant hypertension in chronic kidney disease patients on hemodialysis. This study shall include patients aged more than 18 years undergoing hemodialysis and having urine output more than 200 ml/day. The primary and secondary objectives of the study shall be to assess safety and efficacy of Sacubitril/Valsartan respectively in control of resistant hypertension in CKD 5D patients. All patients fulfilling inclusion and exclusion criteria shall be given a run-in period of 2 weeks to exclude ’pseudoresistant’ hypertension by optimising their hemodialysis to achieve their dry body weight and ensuring a sodium restricted diet. Those patients having resistant hypertension post this run-in period shall be given Sacubitril/Valsartan therapy. These patients shall be given thrice a week hemodialysis at dialysis centre in PGIMER Chandigarh. The patients shall be regularly monitored with regards to their serum electrolytes, liver function tests and any adverse effects. The effectiveness of Sacubitril/Valsartan shall be studied with respect to control of office BP, ambulatory BP and if any change in echocardiographic parameters. Sacubitril/Valsartan combination therapy has stood as a potent antihypertensive in previous metanalysis and randomised trials assessing its efficacy in control of resistant hypertension in chronic kidney disease patients. Participation in the study is expected to be beneficial to the patients as control of their hypertension has definite cardiovascular mortality and morbidity benefits. |