| CTRI Number |
CTRI/2025/10/096081 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Are children and adolescents living with nephrotic syndrome at higher risk for developing hypertension ? |
|
Scientific Title of Study
|
Profile of Continuous ambulatory blood pressure monitoring in children and adolescents with nephrotic syndrome |
| 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 Shrishti Rai |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital
Central
DELHI
110002
India |
| Phone |
8510037567 |
| Fax |
|
| Email |
shristirai25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Mantan |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
2nd floor
Department of Pediatrics
Maulana Azad Medical College and associated Lok Nayak Hospital
Central
DELHI
110002
India |
| Phone |
9968604315 |
| Fax |
|
| Email |
muktamantan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrishti Rai |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics
Maulana Azad Medical College and associated Lok Nayak Hospital
Central
DELHI
110002
India |
| Phone |
8510037567 |
| Fax |
|
| Email |
shristirai25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak, G.B Pant and G.N.E.C hospitals, New Delhi - 110002
Delhi India
|
|
|
Primary Sponsor
|
| Name |
Dr Mukta Mantan |
| Address |
Director Professor
Department of Pediatrics
Maulana Azad Medical College and associated Lok Nayak Hospital
New Delhi- 110002
India |
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrishti Rai |
Department of Cardiology |
G B Pant institute of postgraduate medical education and research hospital
Central
DELHI |
8510037567
shristirai25@gmail.com |
| Dr Shrishti Rai |
Department of Pediatrics |
Maulana Azad Medical College and associated Lok Nayak Hospital
Central
DELHI |
8510037567
shristirai25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Maulana Azad Medical College New Delhi-110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N04||Nephrotic syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All children and adolescents detected with steroid sensitive or steroid resistant nephrotic syndrome having the disease for at least last two years and are in partial or complete remission |
|
| ExclusionCriteria |
| Details |
1. Children with eGFR less than 60 ml per min per
1.73 meter squares.
2. Children diagnosed with diabetes mellitus, familial hyperlipidemia syndromes, stage 2 or more of hypertension.
3. Children with nephrotic syndrome who had infrequently relapsing course throughout.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Determination of mean systolic, diastolic blood pressures during day and night time using continuous ambulatory blood pressure monitor for detection of hypertension or masked hypertension.
Identifying systolic and diastolic loads over a 24 hours period and nocturnal dipping in study population. |
baseline and for next 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association of hypertension with duration, type & treatment (dosage & duration of steroids, calcineurin inhibitors, antihypertensives) of nephrotic syndrome.
Proportion of patients with left ventricular hypertrophy. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/10/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Nephrotic syndrome is the most frequent pediatric glomerular disease,
affecting from 1.15 to 16.9 per 100,000 children per year globally , characterized by alterations of
perm-selectivity at the glomerular capillary wall, resulting in its inability
to restrict the urinary loss of protein and manifested as edema,
hypoalbuminemia and hyperlipidemia. Almost 80 percent of the
children with nephrotic syndrome (NS) have steroid sensitive disease and show
minimal changes on renal histology and respond to steroid therapy. Most
patients both with steroid sensitivity or steroid resistant nephrotic syndrome
receive oral prednisolone for prolonged periods. Besides, hypercholesterolemia
is a ubiquitous finding in nephrotic syndrome, the magnitude of dyslipidemia
directly correlates with the severity of proteinuria. Children with nephrotic syndrome have been shown
to be at a higher risk of hypertension due to the underlying condition, use of
corticosteroids for prolonged periods and use of medications like calcineurin
inhibitors. Ambulatory hypertension,
abnormalities in blood pressure (BP) circadian rhythm, and measures of BP
variability are prevalent in patients with NS. Left ventricle hypertrophy (LH) is strongly
associated with hypertension in children, especially with masked hypertension. Hence, casual blood pressure monitoring alone is
insufficient for detection of hypertension induced LVH. Continuous ambulatory
blood monitoring (CABPM) measures blood pressure for 24 hours during normal
physical activity rather than a single instant, thus allowing assessment of 24 hour blood pressure profile of a patient and nocturnal dipping which is often lost early prior to the onset of overt
hypertension in children and adults. For methodology of the study, an informed consent and or assent will be taken from patient and caregivers before enrolling for the study. A study Performa shall be filled that will include baseline information (age, diagnosis, duration of NS, treatment
details) of
the patient. A detailed examination and anthropometry will be done and recorded Anthropometry values (weight,
height, BMI) will be categorized using
India Academy of Pediatrics charts. Biochemical
investigations including hemogram, kidney function tests, serum albumin, lipid profile, HbA1c will be
done at baseline for all patients by drawing a 2ml blood sample. Casual BP will be measured and patient
will be admitted for 24 hours
for Continuous ambulatory blood pressure monitoring using CABPM device AND
TM2441 which will record BP readings
every 30 minutes during daytime and every 1 hour at night
for a 24 hours period using an optimum Pediatric size cuff placed on the
non-dominant arm of the patient. An echocardiography for detection of left ventricular hypertrophy will be
done for all patients and
the indices that will be measured are- interventricular septal thickness, LV
posterior wall thickness and LV mass index. BP
loads will be calculated from the data-(percentage of readings above the
ambulatory 95th percentile for both SBP and DBP during the entire 24-hour awake
and sleep periods). The cut off for CABPM values will be taken from the
references provided by the German Collaboration Group (Aged 6 yr or > 120cm
height). Based
on these results the patients would be categorized into different categories of
hypertension.
|