NCT06706791

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for phase_4

Timeline
6mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

November 22, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

November 22, 2024

Last Update Submit

March 19, 2025

Conditions

Chronic Heart Failure

Keywords

CHF DM type II

Outcome Measures

Primary Outcomes (1)

  • improvement in Kansas city cardiomyopathy questionnaire scoring

    Primary outcome measure will be the improvement in quality of life indicating by change in Kansas City cardiomyopathy questionnaire (KCCQ) scoring. higher value indicates better results.

    18 months

Secondary Outcomes (1)

  • assessment of NT-pro-BNP levels.

    18 months

Study Arms (2)

experimental arm, Palcebo controlled group

EXPERIMENTAL

Experimental arm, taking empagliflozin 10mg once daily along with standard treatment.

Drug: Empagliflozin 10 MG

Palcebo controlled group

PLACEBO COMPARATOR

Palcebo controlled group patient receiving placebo to compare with empagliflozin along with standard treatment.

Drug: Empagliflozin 10 MG

Interventions

Empagliflozin 10 MGDRUG

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.

Also known as: Horizon,
Palcebo controlled groupexperimental arm, Palcebo controlled group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fazaia Ruth Pfau Hospital

Karachi, Sindh, 75120, Pakistan

RECRUITING

Related Publications (8)

  • 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.

    PMID: 34447992BACKGROUND

  • 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: 28492288BACKGROUND

  • 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: 34556318BACKGROUND

  • 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: 31466618BACKGROUND

  • 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: 26378978RESULT

  • 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.

    PMID: 35379503RESULT

  • 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.

    PMID: 32865377RESULT

  • 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.

    PMID: 34555929RESULT

Related Links

MeSH Terms

Interventions

empagliflozin

Study Officials

  • Tooba Riaz, MBBS

    Fazaia Ruth Pfau Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tooba Riaz, MBBS

CONTACT

03333231665drtoobariaz@outlook.com

DR Asghar Mehdi, MBBS Phd

CONTACT

03008228284drasgharmehdi@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The study will employ a double blind masking approach to ensure unbiased results and mainbtain the integrity of data participants masking; participants will be unaware of whether they are receiving Empagliflozin or placebo investigator masking; healthcare professionals and investigators administering the treatment will not know the treatment assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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 18 months Setting Will take place in Fazaia Ruth Pfau medical college and hospital and NICVD hospital Karachi.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical reseacher resident in FCPS Pharmacology

Study Record Dates

First Submitted

November 22, 2024

First Posted

November 27, 2024

Study Start

April 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

it will be shared if required by relevent authorities

Locations

PA(1)