To evaluate the efficacy of dapagliflozin in diabetic and non diabetic patients with acute heart failure
Design
Prospective randomized control study
Settings and conduct
Pharmacology department of public sector hospital, National University of medical sciences in collaboration with cardiology deprtment of a public sector hospital.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. Male/Female patients 18 years and above
2. Diagnosis of acute decompensated heart failure made on admission
3. Left ventricular Ejection fraction ≤ 40%
Any two of the following signs and symptoms
a) Dyspnea at rest or minimal exertion
b) Peripheral edema
c) Ascites
d) 5-pound weight gain (rapid)
e) Signs of congestion on X-ray
4. eGFR ≥ 30ml/min
Exclusion Criteria:
1. Cardiogenic shock
2. urgent hospitalization for acute heart failure primarily triggered by pulmonary embolism,
cerebrovascular accident, or acute myocardial infarction (AMI)
3. Current hospitalization for acute heart failure not caused primarily by intravascular volume
overload;
Type 1 Diabetes mellitus
4. History of Diabetic ketoacidosis
5. History of hepatic impairment
6. Known allergy to SGLT 2 inhibitors
7. women pregnant or breast feeding
Intervention groups
Control and study Groups
The control group will be prescribed with conventional treatment for acute heart failure
the study group will be prescribed with Dapagliflozin as add on therapy to the conventional treatment for
Acute heart failure
Main outcome variables
1. Effect of dapagliflozin in causing pulmonary decongestion.
2. Effect of dapagliflozin in improving quality of life assessed by KCCQ
3. Effect of dapagliflozin on eGFR
General information
Reason for update
Acronym
AHF( Acute Heart Failure)
IRCT registration information
IRCT registration number:IRCT20220529055013N1
Registration date:2022-06-23, 1401/04/02
Registration timing:prospective
Last update:2022-06-23, 1401/04/02
Update count:0
Registration date
2022-06-23, 1401/04/02
Registrant information
Name
Fauzia Gilani
Name of organization / entity
National University of Science & Technology
Country
Pakistan
Phone
+92 51 2300714
Email address
fauziagilani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-01, 1401/04/10
Expected recruitment end date
2022-12-31, 1401/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Dapagliflozin in diabetic and nondiabetic patients with Acute heart failure
Public title
Dapagliflozin in Acute Heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Male/Female patients 30 years and above
2. Diagnosis of acute decompensated heart failure made on admission based on any two of the following signs and symptoms a)Dyspnea at rest or minimal exertion b)Peripheral edema c) Ascites d)5-pound weight gain (rapid) e) Signs of congestion on X-ray
3. Left ventricular Ejection fraction ≤ 40%
4. eGFR ≥ 30ml/min
Exclusion criteria:
Cardiogenic shock;
urgent hospitalization for acute heart failure primarily triggered by pulmonary embolism ,cerebrovascular accident, or acute myocardial infarction
Current hospitalization for acute heart failure not caused primarily by intravascular volume overload
Type 1 Diabetes mellitus
History of Diabetic ketoacidosis
History of hepatic impairment
Known allergy to SGLT 2 inhibitors
Women pregnant or breast feeding
Age
From 30 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be divided into groups as control and study groups.
the study drug( dapagliflozin) will be prescribed as add on therapy to the conventional treatment of acute heart failure in a 1:1.
simple randomization in 1:1 among the individuals taking participation in the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study participants will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics review committee of public sector hospital
Street address
the mall, abid majeed road
City
Rawalpindi
Postal code
46000
Approval date
2022-03-31, 1401/01/11
Ethics committee reference number
S/017/2022
Health conditions studied
1
Description of health condition studied
Heart failure with reduced ejection fraction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Improvement in symptoms and quality of life of heart failure patients admitted with acute decompensation
Timepoint
At admission( baseline), followed at Day 1,day7 and day 30
Method of measurement
Kansas city cardiomyopathy questionnaire (KCCQ)
2
Description
Effect of drug on kidney function
Timepoint
At day 0, 1, 7 and 30
Method of measurement
estimated glomerular filtration rate ( eGFR)
Secondary outcomes
1
Description
Improvement in Hemoglobin levels
Timepoint
Day 0, 1, 7 and day 30
Method of measurement
complete blood count
2
Description
Blood pressure
Timepoint
Day 0,1 7 and 30
Method of measurement
Sphygmamometer
Intervention groups
1
Description
Intervention group: Tab Dapagliflozin 10 mg orally as add on therapy to the conventional treatment will be prescribed to the study participants
Category
Treatment - Drugs
2
Description
Control group: The participants in this group will be prescribed with the conventional treatment for heart failure
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Public Sector hospital in Rawalpindi ( cardiology department)
Full name of responsible person
Syedah Fauzia Fatima Gilani
Street address
the mall, abid majeed road
City
Rawalpindi
Postal code
46000
Phone
+92 335 5858327
Email
fauziagilani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Public Sector medical University
Full name of responsible person
Mudassar Noor
Street address
The mall, Abid Majeed Road
City
Rawalpindi
Postal code
46000
Phone
+92 51 9270677
Email
smilingdr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Public Sector medical University
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
National University of medical Sciences
Full name of responsible person
Syedahh Fauzia Fatima Gilani
Position
Mphil Trainee
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
The mall, Abid Majeed road
City
Rawalpindi
Province
punjab
Postal code
46000
Phone
+92 51 2300714
Email
fauziagilani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Public Sector Medical College
Full name of responsible person
Syedah Fauzia Fatima GIlani
Position
Mphil Trainee
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
the mall, Abid Majeed road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
0092 51
Email
fauziagilani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Public Sector medical College
Full name of responsible person
Syedah Fauzia Fatima Gilani
Position
Mphil Trainee
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
the mall, abid majeed road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 2300714
Email
fauziagilani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
title: Results. Tables and graphs of primary outcome and secondary outcome will be shared.
When the data will become available and for how long
it will be given in the duration of 10 months to 36 months after publishing. It will be available lifelong
To whom data/document is available
everyone
Under which criteria data/document could be used
everyone who want to take advantage of this trial results will be allowed for the service of humanity.
From where data/document is obtainable
They can talk to principal investigator of this trial Syedah Fauzia Fatima Gilani. E-mail: fauziagilani@gmail.com
What processes are involved for a request to access data/document