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CTRI Number  CTRI/2020/07/026524 [Registered on: 13/07/2020] Trial Registered Prospectively
Last Modified On: 20/08/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Disease Registry (Longitudinal) 
Study Design  Other 
Public Title of Study   Observational study to understand and evaluate the clinical practice patterns and outcomes of hypertension in high risk hypertensive patients in India 
Scientific Title of Study   Prospective observational study to determine aetiologies, presentation, clinical practice patterns and outcomes of hypertension in high risk hypertensive patients in India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GGI-Hypertension-Registry-01-20 version 01 7-Apr-2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohammed Yunus Khan 
Designation  Team Lead - Medical Affairs 
Affiliation  Dr. Reddys Laboratories 
Address  Medical Affairs, Dr. Reddys Lab, 7-1-27, Ameerpet Road, Ameerpet, Hyderabad

Hyderabad
TELANGANA
500016
India 
Phone  04049048400  
Fax  04049048800  
Email  myunuskhan@drreddys.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammed Yunus Khan 
Designation  Team Lead - Medical Affairs 
Affiliation  Dr. Reddys Laboratories 
Address  Medical Affairs, Dr. Reddys Lab, 7-1-27, Ameerpet Road, Ameerpet, Hyderabad

Hyderabad
TELANGANA
500016
India 
Phone  04049048400  
Fax  04049048800  
Email  myunuskhan@drreddys.com  
 
Details of Contact Person
Public Query  
Name  Sucheta Pandit 
Designation  Clinical Research Specialist 
Affiliation  Dr. Reddys Laboratories 
Address  Medical Affairs, Dr. Reddys Lab, 7-1-27, Ameerpet Road, Ameerpet, Hyderabad

Hyderabad
TELANGANA
500016
India 
Phone  04049048400  
Fax  04049048800  
Email  suchetaakshay.p@drreddys.com  
 
Source of Monetary or Material Support  
Dr. Reddys Lab, 7-1-27, Ameerpet Raod, Ameerpet, Hyderabad, Telangana - 500016 
 
Primary Sponsor  
Name  Dr Reddys Laboratories Ltd 
Address  7-1-27, Ameerpet Road, Ameerpet, Hyderabad, Telangana - 500016 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jay Shah  HCG Hospital  HCG Hospital, Mithakhali Six Rd, Kalyan Society, Maharashtra Society, Ellisbridge, Ahmedabad, Gujarat 380006
Ahmadabad
GUJARAT 		 9898209755

drjayshah1975@gmail.com 
Dr Jabir Abdullakutty  Lisie Hospital Rd  Lisie Hospital Rd, North Kaloor, Kaloor, Ernakulam, Kerala 682018
Ernakulam
KERALA 		 9447011773

drjabi@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee of Lisie Hospital,  Approved 
HCG Multi Specialty Ethics Committee  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Patient willing to give informed consent.
2. Patients both males and females 18 years or older with essential hypertension (As per ESC/ESH 2018 and IGH 2019 guidelines) for at least 4 weeks, following up in public and private centres and after signing a consent form.
3. Patients defined as high-risk and very high-risk hypertensive as per ESC/ESH 2018 [17] and IGH 2019 guidelines [11] as per the check-list below:
a. Grade 3 hypertension (SBP ≥180 mm Hg OR DBP ≥110 mm Hg) with any one of the following:
i. No risk, 1-2 risk factor or ≥3 cardiovascular risk factors
ii. Asymptomatic HMOD (hypertension-mediated organ damage)
iii. CKD grade 3 (eGFR >30 to 59 ml/min/1.73m2), or grade 4 (eGFR <30 ml/min/1.73m2)
iv. Diabetes mellitus without/with organ damage
v. Established CVD

b. Grade 2 hypertension (SBP 160-179 mm Hg OR DBP 100-109 mm Hg) with any one of the following:
i. Uncomplicated hypertension with ≥3 cardiovascular risk factors
ii. Asymptomatic HMOD (hypertension-mediated organ damage)
iii. CKD grade 3 (eGFR >30 to 59 ml/min/1.73m2), or grade 4 (eGFR <30 ml/min/1.73m2)
iv. Diabetes mellitus without/with organ damage
v. Established CVD

c. Grade 1 hypertension (SBP 140-159 mm Hg OR DBP 90-99 mm Hg) with any one of the following:
i. Asymptomatic HMOD (hypertension-mediated organ damage)
ii. CKD grade 3 (eGFR >30 to 59 ml/min/1.73m2), or grade 4 (eGFR <30 ml/min/1.73m2)
iii. Diabetes mellitus without/with organ damage
iv. Established CVD 
 
ExclusionCriteria 
Details  1. Patients with secondary hypertension (secondary hypertension is the hypertension caused by an identifiable underlying primary cause).
2. Pregnant and lactating women.
3. Patient refusing consent for enrolment.
4. Any patient as per the discretion of the physician. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Proportion of patients achieving their BP goals as per latest hypertension guidelines (ESC/ESH 2018 and IGH 2019 guidelines) at 12 months  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of patients with macrovascular clinical outcomes – [All-cause mortality, MI, stroke, Coronary artery disease, heart failure [HF], and peripheral arterial disease)] at 12 months  12 months 
2. Proportion of patients with microvascular clinical outcomes – [retinopathy, nephropathy and neuropathy] at 12 months  12 months 
3. Proportion of high-risk hypertensive patients with both modifiable and non-modifiable risk factors at baseline  Baseline 
Proportion of patients with Co-morbidities at baseline (DM, Dyslipidaemias, CKD, CVD, Heart Failure, Stroke/TIA, MI, Neuropathy, Retinopathy and/or Other)   Baseline 
5. Clinical practice patterns (diagnosis [parameters considered to make diagnosis; routine diagnostic measures], treatment and drug utilization patterns, investigations [investigations performed to evaluate the patients]) and relationship to clinical outcomes  Baseline 
 
Target Sample Size   Total Sample Size="5000"
Sample Size from India="5000" 
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)   14/07/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Prospective observational study to determine aetiologies, presentation, clinical practice patterns and outcomes of hypertension in high risk hypertensive patients in India.
Despite the high prevalence of HTN in India, the awareness, treatment and control status are low in Indian in urban as well as rural populations. This could be attributed to a variety of socioeconomic factors - low educational status, poverty, rural residence, as well as physiological factors like obesity. This study aims to collect real-world data from Indian population about the blood pressure control with the antihypertensive drugs used in high-risk hypertensives.
 
 
 
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