| CTRI Number |
CTRI/2022/11/047725 [Registered on: 28/11/2022] Trial Registered Prospectively |
| Last Modified On: |
28/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Dapagliflozin in Heart Failure |
|
Scientific Title of Study
|
Efficacy and Safety of addition of Dapagliflozin to conventional therapy in patients of Heart Failure with Mildly Reduced and Preserved Ejection Fraction: A placebo controlled double blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjay Kumar R |
| Designation |
PG Resident Pharmacology |
| Affiliation |
G R Medical College |
| Address |
J A group of Hospitals
Department of Cardiology
Room no 62
Gwalior
MP
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9686805769 |
| Fax |
|
| Email |
sanjayholmes96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saroj Kothari |
| Designation |
Professor and Head of Pharmacology Department |
| Affiliation |
G R Medical College |
| Address |
Department of Pharmacology
Gajara Raja Medical College
Gwalior
MP
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9827322002 |
| Fax |
|
| Email |
saroj.kothari@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay Kumar R |
| Designation |
PG Resident Pharmacology |
| Affiliation |
G R Medical College |
| Address |
J A Group of Hospitals
Department of Cardiology
Room no 62
Gwalior
MP
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9686805769 |
| Fax |
|
| Email |
sanjayholmes96@gmail.com |
|
|
Source of Monetary or Material Support
|
| G R Medical College
Veer Savarkar Margh
Gwalior
Madhya Pradesh
474009 |
|
|
Primary Sponsor
|
| Name |
Sanjay Kumar R |
| Address |
G R Medical College
Gwalior
MP 474009 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sanjay Kumar R |
J A Group of Hospitals |
Department of Cardiology
OPD
Room no 62
Gwalior
474009
Gwalior
MADHYA PRADESH |
9686805769
sanjayholmes96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, J A Group of Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I501||Left ventricular failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dapagliflozin |
SGLT2 inhibitor
10mg daily tablet given for one group
Dose 10mg OD morning, oral route, for 6 months |
| Comparator Agent |
Placebo |
placebo
one tablet per day
oral route
for 6 months |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing singned informed consent
2.Patients with documented diagnosis of HFpEF and HFmrEF with medical history of symptoms and signs of Heart Failure
3.Patients with LVEF 40-60% or evidence of structural Heat disease |
|
| ExclusionCriteria |
| Details |
1.Patients who are not willing to sign informed consent.
2.Patients with LVEF <40%
3.Patients with eGFR <25ml/min/1.73m3
4.Patients who are intolerance to Dapagliflozin |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Dapagliflozin over placebo (blood and eco-cardiogram parameters) when added to standard regimen in HFpEF and HFmrEF |
At baseline, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Safety and tolerability of Dapagliflozin
3.improvement in patent reported outcomes measured by KCCQ-12(Kansas City Cardiomyopathy Questioner) |
baseline, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/12/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Heart Failure is a complex clinical
syndrome that results from any structural or functional impairment of
ventricular filling or ejection of blood leading to cardinal manifestations of
dyspnea, fatigue and fluid retention •Treatment
of HFpEF and HFmrEF is heavily symptom based without specific pharmacological
therapies to modify disease progression.
•Dapagliflozin
is Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor originally developed as
glucose lowering agent. Later studies have shown to reduce hospitalization in
Heart Failure patients with reduced Ejection Fraction.
•Whether
the benefits of SGLT2 inhibitors observed in HFrEF extend to patients with
HFpEF is unknown.
•SGLT2
Inhibitors are found helpful in improving congestion, improved renal function,
diastolic function, reducing visceral fat (including epidural fat), reducing
atrial stiffness, have favourable effects on endothelial function and
inflammation. All these are important mechanisms by which pathogenesis of HFpEF
can be improved.
Therefore,
we have planned this study to find the efficacy of dapagliflozin in HFmrEF and
HFpEF and to establish its effectiveness in full spectrum of Ejection Fraction |