Effect of Empagliflozin on Quality of Life in Chronic Heart Failure Patients With Diabetes Mellitus Type II
NCT ID: NCT06706791
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
156 participants
INTERVENTIONAL
2025-04-01
2026-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
As per American College of Cardiology (ACC)/American Heart Association (AHA) Empagliflozin is recommended in both diabetic and non-diabetic HF (especially beneficial in patients with HFrEF and HFpEF).
The aim of my study is to assess the impact of Empagliflozin on quality of life in Pakistani patients, considering the genetic, environmental and cultural factors.
The study will also explore whether Empagliflozin can offer cost-effective option for managing chronic heart failure and diabetes, potentially reducing the economic burden on both patients and health care system.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects
NCT03485092
Investigation of Biomarker Response to SGLT2 Inhibition in Heart Failure
NCT06140251
Antiischemic Effects of Empagliflozin in Diabetic Patients With Refractory Angina
NCT04143321
Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure
NCT06507657
Empagliflozin as a Modulator of Systemic Vascular Resistance and Cardiac Output in Patients With Type 2 Diabetes
NCT03132181
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a comparative clinical study with randomized groups. Participants will be allocated to either the Empagliflozin group or the placebo group alongside standard therapy.
Blinding will be done by assigning drug to participants according to computer generated numbers in 2 groups in 1:1 ratio.
Empagliflozin Group: taking Empagliflozin 10mg once daily per oral along with standard treatment. Their quality of life assessed by using Kansas City Cardiomyopathy questionnaire. Placebo Group: Identical placebo tablets, following the same dose and schedule as the Empagliflozin group along with standard treatment of chronic heart failure.
Duration is of18 months. Will take place in Fazaia Ruth Pfau medical college and hospital and NICVD hospital Karachi.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Blinding will be done by assigning drug to participants according to computer generated numbers in 2 groups in 1:1 ratio.
Empagliflozin Group: taking Empagliflozin 10mg once daily per oral along with standard treatment. Their quality of life assessed by using Kansas City Cardiomyopathy questionnaire. Placebo Group: Identical placebo tablets, following the same dose and schedule as the Empagliflozin group along with standard treatment of chronic heart failure.
Duration 18 months Setting Will take place in Fazaia Ruth Pfau medical college and hospital and NICVD hospital Karachi.
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
experimental arm, Palcebo controlled group
Experimental arm, taking empagliflozin 10mg once daily along with standard treatment.
Empagliflozin 10 MG
participants will be divided in two groups one group will empagliflozin 10mg once daily along with standard treatment secong group receiving placebo once daily along with standard treatment.
Palcebo controlled group
Palcebo controlled group patient receiving placebo to compare with empagliflozin along with standard treatment.
Empagliflozin 10 MG
participants will be divided in two groups one group will empagliflozin 10mg once daily along with standard treatment secong group receiving placebo once daily along with standard treatment.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Empagliflozin 10 MG
participants will be divided in two groups one group will empagliflozin 10mg once daily along with standard treatment secong group receiving placebo once daily along with standard treatment.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Both Men and women are included in study.
3. Patients with chronic heart failure and currently categorized in class II-IV heart failure as per NHYA classification having ejection fraction less than 40%.
4. Patients having NT- proBNP levels greater than 25pg/ml.
5. Diabetic patient diagnosed (HbA1c \> 6.5mg/dl) and currently taking antidiabetic medicine.
Exclusion Criteria
2. Patient with end stage renal disease (ESRD).
3. Patient with acute decompensated heart failure.
4. Acute coronary syndrome patients.
40 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fazaia Ruth Pfau Medical College
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tooba Riaz
clinical reseacher resident in FCPS Pharmacology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tooba Riaz, MBBS
Role: PRINCIPAL_INVESTIGATOR
Fazaia Ruth Pfau Medical College
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fazaia Ruth Pfau Hospital
Karachi, Sindh, Pakistan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
Dunlay SM, Roger VL, Redfield MM. Epidemiology of heart failure with preserved ejection fraction. Nat Rev Cardiol. 2017 Oct;14(10):591-602. doi: 10.1038/nrcardio.2017.65. Epub 2017 May 11.
Januzzi JL Jr, Zannad F, Anker SD, Butler J, Filippatos G, Pocock SJ, Ferreira JP, Sattar N, Verma S, Vedin O, Schnee J, Iwata T, Cotton D, Packer M; EMPEROR-Reduced Trial Committees and Investigators. Prognostic Importance of NT-proBNP and Effect of Empagliflozin in the EMPEROR-Reduced Trial. J Am Coll Cardiol. 2021 Sep 28;78(13):1321-1332. doi: 10.1016/j.jacc.2021.07.046.
Januzzi JL Jr, Ahmad T, Mulder H, Coles A, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston-Miller N, Mark DB, Pina IL, Passmore G, Whellan DJ, Cooper LS, Leifer ES, Desvigne-Nickens P, Felker GM, O'Connor CM. Natriuretic Peptide Response and Outcomes in Chronic Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2019 Sep 3;74(9):1205-1217. doi: 10.1016/j.jacc.2019.06.055.
Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1.
Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Bohm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28.
Stubblefield WB, Jenkins CA, Liu D, Storrow AB, Spertus JA, Pang PS, Levy PD, Butler J, Chang AM, Char D, Diercks DB, Fermann GJ, Han JH, Hiestand BC, Hogan CJ, Khan Y, Lee S, Lindenfeld JM, McNaughton CD, Miller K, Peacock WF, Schrock JW, Self WH, Singer AJ, Sterling SA, Collins SP. Improvement in Kansas City Cardiomyopathy Questionnaire Scores After a Self-Care Intervention in Patients With Acute Heart Failure Discharged From the Emergency Department. Circ Cardiovasc Qual Outcomes. 2021 Oct;14(10):e007956. doi: 10.1161/CIRCOUTCOMES.121.007956. Epub 2021 Sep 24.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FMC,Air university
Identifier Type: OTHER
Identifier Source: secondary_id
FRPMC-IRB-2024-64
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.