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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 -

SLCTR Registration Number

SLCTR/2017/041


Date of Registration

20 Dec 2017

The date of last modification

Jan 08, 2018



Application Summary


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 of 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


Trial Details


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


Purpose


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)

urinary sodium level in a spot urine sample


Primary outcome(s) - Time of assessment(s)

day 1, day 3 and day 5


Secondary outcome

Measurement of 24 hour urine output and daily weight in kg


Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Pending


State of ethics review approval

Approved by the Rehman Medical Institute Research Ethical Committee on 16th September 2017


Funding source

Hospital



Contact & Sponsor Information


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

Secondary study sponsor (If any)

None