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CTRI Number  CTRI/2018/01/011581 [Registered on: 29/01/2018] Trial Registered Retrospectively
Last Modified On: 21/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Night Time Antihypertensive on Blood Pressure pattern in CKD III-IV: A Randomized Controlled Trial 
Scientific Title of Study   A Randomized Controlled Trial on the Effect of Night Time Dosing of Antihypertensives on Ambulatory Blood Pressure Monitoring and Cardiovascular and Renal Outcomes in Nondialysis CKD Patients  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaibhav Tiwari 
Designation  DOCTOR 
Affiliation  IPGMER 
Address  Department of Nephrology IPGMER, SSKM HOSPITAL 244 AJC Bose Road Bhowanipur

Kolkata
WEST BENGAL
700020
India 
Phone  9740352874  
Fax    
Email  drvt87@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sanjay Dasgupta 
Designation  Doctor 
Affiliation  IPGMER 
Address  Department of Nephrology IPGMER, SSKM HOSPITAL 244 AJC Bose Road Bhowanipur

Kolkata
WEST BENGAL
700020
India 
Phone  9830082267  
Fax    
Email  dasgupta.sanjay@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Vaibhav Tiwari 
Designation  DOCTOR 
Affiliation  IPGMER 
Address  Department of Nephrology IPGMER, SSKM HOSPITAL 244 AJC Bose Road Bhowanipur

Kolkata
WEST BENGAL
700020
India 
Phone  9740352874  
Fax    
Email  drvt87@gmail.com  
 
Source of Monetary or Material Support  
IPGMER snd SSKM Hospital Nephrology department 244 AJC Bose Road Bhowanipur Kolkata 700020 
 
Primary Sponsor  
Name  IPGMER snd SSKM Hospital 
Address  244 AJC Bose Road bhowanipur kolkata 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vaibhav Tiwari  SSKM Hospital  Department of Nephrology IPGMER, SSKM HOSPITAL 244 AJC Bose Road Bhowanipur
Kolkata
WEST BENGAL 		 9740352874

drvt87@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R Resarch Oversight Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  chronic kidney disease patient,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Awakening group  Dose and Frequency as per physician discretion to control the Blood Pressure Only morning or afternoon dose No night time antihypertensive to be given Route is oral administration 1 year of duration 
Intervention  Bedtime group  Antihypertensive Dose as per physician discretion to control Blood Pressure Addition of antihypertensive in night time only Oral route only Duration of therapy is 1 year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. MDRD eGFR ≤ 60 ml/min/1.73 m2, irrespective of underlying NKD
2. Patients of either sex who were 18 years of age or older are eligible.
3. Patients on antihypertensives taking ≥ 1 drug(s) of which at least 1 dose is being taken in morning or afternoon
4. Patients should be ambulatory
 
 
ExclusionCriteria 
Details  1. Suspicion of secondary hypertension, other than CKD.
2. Recent stroke (occurring within the previous 3 months).
3. Recent acute myocardial infarction.
4. Recent hospitalization for heart failure
5. Recent revascularization or planned cardiovascular intervention
6. MDRD eGFR <15 ml/min/1.73 m2 or dialysis requiring
7. Uncontrolled Hypertension (systolic BP>150 mmHg or diastolic BP>90mmHg)
8. Pregnancy
9. Atrial fibrillation
Refusal to undergo repeated follow up visits and ambulatory blood pressure monitoring. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Conversion to dipper pattern from non dipper in two groups
2. Rate of fall of eGFR in two groups
3. Change in cardiac structure like LV Mass Index and LV ejection fraction 		 Conversion to dipper from non dipper at 3 months
Change in eGFR and Cardiac structure at 1 year
 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in 24 hour proteinuria  1 year 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/06/2017 
Date of Study Completion (India) 29/12/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   the present study was conducted in the dept. of Nephrology at IPGMER. The aim was to study the effect of night time dosing of antihypertensives on BP profile of CKD III and IV patients. cardiovascular and renal outcome was evaluated at the end of 1 year. 96 patients were assessed eligibility. All patients underwent ABPM at baseline, 11 patients were excluded due to uncontrolled hypertension, 10 patients had dipping pattern. 75 were randomized into 2 groups. 36 patients were grouped as Awakening group who continue to take their medication as previously prescribed. 39 patients were grouped as Bedtime group who either split their antihypertensive to the night time or add additional antihypertensive at the night time. All patients underwent repeat ABPM at 3 months. final analysis was done at end of 1 year. In results there was significant GFR decline noted in awakening group as compared to bedtime group.10 patients reverted to dipping pattern in bedtime group. the percentage decrease of ACR showed favourable trend in bedtime group. cardiovascular outcomes were similar in both the groups. in conclusion, night time antihypertensive medication provides better renal protection with slowing of eGFR decline 
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