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Recruiting NCT06706791

Effect of Empagliflozin on Quality of Life in Chronic Heart Failure Patients With Diabetes Mellitus Type II

Phase IV Interventional Chronic Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Empagliflozin 10 MG.
Who it may be relevant to
Registry conditions: Chronic Heart Failure. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Effect of Empagliflozin on Quality of Life in patient of Chronic Heart Failure with Diabetes Mellitus Type II. As per ESC Guidelines Empagliflozin is recommended as part of the first-line treatment for HFrEF, irrespective of diabetes status. 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.

Detailed description

Effect of Empagliflozin on Quality of Life in patient of Chronic Heart Failure with Diabetes Mellitus Type II. As per ESC Guidelines Empagliflozin is recommended as part of the first-line treatment for HFrEF, irrespective of diabetes status.

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.

Interventions

  • Drug 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.

Primary outcome measures

  • improvement in Kansas city cardiomyopathy questionnaire scoring [Time frame: 18 months]
Secondary outcome measures (1)
  • assessment of NT-pro-BNP levels. [Time frame: 18 months]

Eligibility criteria

Inclusion criteria

  • Age 40-70 years at time of screening.
  • Both Men and women are included in study.
  • Patients with chronic heart failure and currently categorized in class II-IV heart failure as per NHYA classification having ejection fraction less than 40%.
  • Patients having NT- proBNP levels greater than 25pg/ml.
  • Diabetic patient diagnosed (HbA1c > 6.5mg/dl) and currently taking antidiabetic medicine.

Exclusion criteria

  • Pregnant female.
  • Patient with end stage renal disease (ESRD).
  • Patient with acute decompensated heart failure.
  • Acute coronary syndrome patients.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Fazaia Ruth Pfau Hospital — Karachi

Publications

  • 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 Gro PMID 34447992
  • 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. PMID 28492288
  • 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. PMID 34556318
  • 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. PMID 31466618
  • 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. PMID 26378978
  • 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 PMID 35379503
  • 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 PMID 32865377
  • 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 Acut PMID 34555929

Identifiers

NCT: NCT06706791 · FRPMC-IRB-2024-64 · FMC,Air university

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗