| CTRI Number |
CTRI/2023/05/052911 [Registered on: 19/05/2023] Trial Registered Prospectively |
| Last Modified On: |
15/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Hypertension in chronic kidney disease patients on hemodialysis |
|
Scientific Title of Study
|
Randomized control trial to compare effect of Atenolol vs Telmisartan in hemodialysis
patients with uncontrolled hypertension. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tukaram Jamale |
| Designation |
Prof and Head |
| Affiliation |
Seth GSMC and KEM hospital Mumbai |
| Address |
34 A third floor Department of Nephrology Old building KEM Hospital
Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09167460362 |
| Fax |
|
| Email |
tukaramjamale@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tukaram Jamale |
| Designation |
Prof and Head |
| Affiliation |
Seth GSMC and KEM hospital Mumbai |
| Address |
34 A third floor Department of Nephrology Old building KEM Hospital
Parel Mumbai 400012
MAHARASHTRA
400012
India |
| Phone |
09167460362 |
| Fax |
|
| Email |
tukaramjamale@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreyashi Bose |
| Designation |
Assistant Professor Contractual |
| Affiliation |
Seth GSMC and KEM hospital Mumbai |
| Address |
34 A third floor Department of Nephrology Old building KEM Hospital
Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9082179924 |
| Fax |
|
| Email |
sreyashi.bose@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Nephrology
KEM Hospital Parel Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Department of Nephrology |
| Address |
34 A Third floor old building KEM Hospital Parel Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tukaram Jamale |
King Edward Memorial Hospital |
Ward 34 A third floor Department of Nephrology Old building KEM Hospital
Parel Mumbai 400012
Mumbai
MAHARASHTRA |
09167460362
tukaramjamale@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Atenolol |
Patients on hemodialysis with uncontrolled blood pressure will be given atenolol 25 mg three times a week and dose will be gradually increased to 100mg three times a week till blood pressure control is attained.
The total duration of intervention cannot be specified as such,as it will be continued till BP Control is achieved. Once the same is achieved the medication will be continued lifelong. |
| Comparator Agent |
Telmisartan |
Patients on hemodialysis with uncontrolled hypertension will be started on tablet telmisrtan 40 mg once daily dose and dose will be escalated to 80 mg once a day till BP control is attained.
The total duration of intervention cannot be specified as such,as it will be continued till BP Control is achieved. Once the same is achieved the medication will be continued lifelong. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All the end stage kidney disease patients, above 18 years of age with written informed consent.
- On Hemodialysis (CKD stage VD) for more than 3 months.
Average of Home BP readings should be more than 135/85mmHg. These readings should be
collected in the morning and in the evening over 6 non-dialysis days (covering a period of 2
weeks). OR
- ABPM reading with an average BP of more than 130/80mmHg over 24-h monitoring during a
mid-week day free of haemodialysis. |
|
| ExclusionCriteria |
| Details |
1. Patients less than 18 yrs of age.
2. Patient with pregnancy.
3. Patients with obstructive airway disease, peripheral vascular disease, uncontrolled blood sugar
levels.
4. Patients with persistent hyperkalemia [K > 6meq/L], or with ECG changes of hyperkalemia
5. Patients planned to undergo renal transplant within 1 year.
6. Patients with CV events in the last 3 months
7. Patients unwilling to give consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OUTCOME
Decrease in Echocardiographic Left Ventricular hypertrophy and Left Ventricular Mass Index at the end of 1 year
|
12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY OUTCOME
Composite Cardiovascular outcome at the end of one year which include heart failure,coronary revascularization (PTCA/ CABG), myocardial ischemia, angina requiring hospitalization,
hemorrhagic and non hemorrhagic intracranial infarcts and intracranial bleeding.
Improvement in ABPM parameter- Average systolic and diastolic BP, Night to day Systolic BP ratio at the end of 1 year.
Adverse effects seen the usage of drugs- hyperkalemia, bradycardia, hypotension (less than 100mmHG systolic BP), arrythmia during 1 year.
Secondary arterio venous fistula failure due to hypotension during 1 year
Number of anti hypertensive medications required for control of blood pressure at 1 year
Number of hospitalization due to cardiac failure during 1 year
Hospitalization due to uncontrolled blood pressure within 1 year
All cause mortality in 1 year.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
01/06/2023 |
| 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
|
Cardiovascular events resulting from uncontrolled hypertension is a leading cause of death in chronic hemodialysis patients. Despite the significant degree of mortality and morbidity, there is a lot of lacunae in our understanding of an ideal drug to control blood pressure for prevention of cardiovascular disease in this population. The majority of cardiovascular primary and secondary prevention clinical trials have excluded patients on hemodialysis. We are doing this trial to compare two common drugs- Atenolol and Telmisartan in hemodialysis patients with uncontrolled blood pressure. Efficacy of the drug will be analysed by BP control, reduction of LVMI (left ventricular mass index) on 2D ECHO. We will also analyse the safety of these 2 drugs in this population. In case any patients develops any side effect, this drug will be immediately stopped and treatment will be provided to the patient free of cost. |