Observational study to understand and evaluate the clinical practice patterns and outcomes of hypertension in high risk hypertensive patients in India

Not Applicable

• Conditions: Health Condition 1: I10- Essential (primary) hypertension

• Registration Number: CTRI/2020/07/026524
• Lead Sponsor: Dr Reddys Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Proportion of patients achieving their BP goals as per latest hypertension guidelines (ESC/ESH 2018 and IGH 2019 guidelines) at 12 monthsTimepoint: 12 months

Secondary Outcome Measures

Name	Time	Method
1.Proportion of patients with macrovascular clinical outcomes â?? [All-cause mortality, MI, stroke, Coronary artery disease, heart failure [HF], and peripheral arterial disease)] at 12 monthsTimepoint: 12 months;2.Proportion of patients with microvascular clinical outcomes â?? [retinopathy, nephropathy and neuropathy] at 12 monthsTimepoint: 12 months;3.Proportion of high-risk hypertensive patients with both modifiable and non-modifiable risk factors at baselineTimepoint: 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 outcomesTimepoint: Baseline;Proportion of patients with Co-morbidities at baseline (DM, Dyslipidaemias, CKD, CVD, Heart Failure, Stroke/TIA, MI, Neuropathy, Retinopathy and/or Other)Timepoint: Baseline