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CTRI Number  CTRI/2025/07/089971 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 08/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Pharmacogenomics of Treatment-Resistant Hypertension: A Study Comparing the Frequency of ENaC and NEDD4L Single Nucleotide Variants in Treatment-Resistant versus Controlled Hypertension  
Scientific Title of Study   Pharmacogenomics of treatment resistant hypertension a study comparing the incidence of SNVs of genes ENaC and NEDD4L in treatment resistant hypertension with controlled hypertension 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajay Prakash 
Designation  Additional Professor 
Affiliation  PGIMER Chandigarh 
Address  4013, Level 4, Department of Pharmacology, Research Block B, PGIMER, Chandogarh.

Chandigarh
CHANDIGARH
160012
India 
Phone  9781119969  
Fax    
Email  ajayprakashpgi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vipul Bharati 
Designation  Junior Resident 
Affiliation  PGIMER Chandigarh 
Address  4013, Level 4, Department of Pharmacology, Research Block B, PGIMER, Chandogarh.

Chandigarh
CHANDIGARH
160012
India 
Phone  9987392304  
Fax    
Email  vipul.bharati.pgi@outlook.com  
 
Details of Contact Person
Public Query  
Name  Dr Ajay Prakash 
Designation  Additional Professor 
Affiliation  PGIMER Chandigarh 
Address  4013, Level 4, Department of Pharmacology, Research Block B, PGIMER, Chandogarh.

Chandigarh
CHANDIGARH
160012
India 
Phone  9781119969  
Fax    
Email  ajayprakashpgi@gmail.com  
 
Source of Monetary or Material Support  
PGIMER Chandigarh 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
Dr Ajay Prakash  PGIMER  4013, Department of Pharmacology, Research Block B, PGIMER Chandigarh, sector 12, 160012
Chandigarh
CHANDIGARH 		 9781119969

ajayprakashpgi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee (Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Cases i.e. patients with Treatment resistant hypertension (TRH): Blood Pressure more than or equal to 130/80 mmHg and, Currently on at least three antihypertensive agents including diuretics and, Received the treatment for 3 months or more.
2. Controls i.e. patients with Controlled hypertension: Blood Pressure less than 130/80 mmHg and, Currently on three or less antihypertensive agents.
3. Willing to give written informed consent  
 
ExclusionCriteria 
Details  1. Diagnosed CKD
2. Diagnosed secondary causes of hypertension
3. Pregnant and lactating women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The frequency of the risk alleles and genotypes of the two selected SNVs (ENaC
(rs80311498) and NEDD4L (rs4149601)) among patients with TRH and controlled
hypertension, expressed as proportions and analyzed for statistical association.  		 At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Mean age at presentation stratified by genotype & correlation analysis between SNV status & age of onset using appropriate statistical tests.
 		 At baseline 
Distribution of the GRS among TRH & control patients & its predictive value in identifying TRH using logistic regression & ROC curve analysis.  At baseline 
Internal consistency (Cronbach’s alpha), test–retest reliability (intraclass correlation coefficient) & construct/criterion validity of the newly developed questionnaire in comparison with the Hill-Bone HBP Therapy Scale, measured in terms of correlation coefficients & predictive association with blood pressure control.   At baseline 
Stratified analysis of SNV prevalence & associations across gender (male/female) & geographic subgroups (urban/rural), identifying any significant interactions or modifiers.  At baseline 
 
Target Sample Size   Total Sample Size="480"
Sample Size from India="480" 
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   N/A 
Date of First Enrollment (India)   12/07/2025 
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)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vipul.bharati.pgi@outlook.com].

  6. For how long will this data be available start date provided 03-06-2027 and end date provided 03-06-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Based on the previous studies conducted, it was found that NEDD4L rs4149601 G-allele (GG/GA) was associated with greater SBP and DBP reduction after six months of monotherapy with Betablockers or Diuretics and better cardiovascular outcomes than AA homozygous genotype. Similarly, the SNV in ENaC R563Q rs80311498 was associated with decreased response to spironolactone in patients with TRH and that these patients might be benefited from amiloride. Thus, we can conclude that these SNVs are responsible for reduced response to Beta-blockers and Diuretics in hypertensive patients resulting in progression to TRH. No data pertaining to the genomics of Indian population in TRH is available. This study will give first hand data related to the genomics of TRH in Indian population. Through this study, we aim to compare the incidence of these SNVs in TRH with Controlled Hypertension. 
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