Home » Trials » SLCTR/2017/041
A randomized controlled trial to compare the efficacy of furosemide and indapamide combination against furosemide and metalozone combination in the sodium excreting effect in congestive heart failure
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SLCTR Registration Number
SLCTR/2017/041
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
A randomized controlled trial to compare the efficacy of furosemide and indapamide combination against furosemide and metalozone combination in the sodium excreting effect in congestive heart failure
Public Title of Trial
Comparison of sodium excreting effect between furosemide and indapamide combination with furosemide and metolazone combination in congestive heart failure patients
Disease or Health Condition(s) Studied
Congestive Heart Failure
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1203-9765
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Is the sodium excreting efficacy of the dual diuretics combination of furosemide and metalozone better/equal or inferior than the combination of furosemide and indapamide?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Rehman Medical Institute Cardiology Department,Hayatabad Peshawar Pakistan.
Method of Randomization: Simple randomization into 2 groups. One group will receive combination of furosemide and metalozone and second group will receive furosemide and indapamide.
First group will receive furosemide I/V 40mg q12hr with metalozone 5mg oral q24hr while second group will receive furosemide I/V 40mg q12hr and indapamide 2.5mg q24hr.
Standard antifailure treatment will continue to both groups.
Inclusion criteria
New York Hear Association Grade –III
New York Hear Association Grade - IV
Adults from 18years to 90years of both genders will be included
Exclusion criteria
Chronic Kidney Disease - Ultrasonographic evidence of chronic kidney disease
Chronic Liver Disease - Ultrasonographic evidence of liver fibrosis
Malnutrition- serum albumin concentration of less than 3g/dl
Primary outcome(s)
|
1.
urinary sodium level in a spot urine sample |
[ day 1, day 3 and day 5 ] |
Secondary outcome(s)
|
1.
Measurement of 24 hour urine output and daily weight in kg |
[ day 1, day 3 and day 5 ] |
Target number/sample size
120 (60 in each arm)
Countries of recruitment
Pakistan
Anticipated start date
2018-01-01
Anticipated end date
2018-06-30
Date of first enrollment
2018-01-01
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Hospital
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-09-16
Approval number
Not availabe
Details of Ethics Review Committee
| Name: | Rehman Medical Institute Research Ethical Committee |
| Institutional Address: | Not available |
| Telephone: | Not available |
| Email: | Not available |
Contact person for Scientific Queries/Principal Investigator
Hammad Shah
Post Graduate Resident
Cardiology Department, Rehman Medical Institute, Hayatabad, Peshawar
Pakistan
Tel: 091-5838000 ext (2181)
Mob: 0333-9244644
drhammadshah@gmail.com
Contact Person for Public Queries
Dr. Afrasyab Altaf
Consultant Cardiologist
Cardiology Department
Rehman Medical Institute
Hayatabad, Peshawar
Pakistan
Tel: +92-91-5838000 ext (2181)
Fax: +92-91-5838333
healthcare@rmi.edu.pk
Primary study sponsor/organization
Rehman Medical Institute
Hayatabad, Peshawar.Pakistan
091-5838000
www.rmi.edu.pk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
