NCT05727423

Brief Summary

prospectively evaluation the safety and efficacy of the Sodium-glucose Cotransporter-2 (SGLT2) inhibitor dapagliflozin in non-diabetic patients with heart failure and a reduced ejection fraction

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

September 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

2.4 years

First QC Date

February 5, 2023

Last Update Submit

January 25, 2024

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • left ventricular ejection fraction

    Assessment of Echo parameters of LV-systolic function as EF

    6 months

Secondary Outcomes (2)

  • left ventricular end-systolic volume, left ventricular end-diastolic volume

    6 months

  • E/e', LAVI, septal e'

    6 months

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In the cardiology department at Ain Shams university hospitals, stable heart failure patients with reduced ejection fraction should fulfill the inclusion and exclusion criteria mentioned above.

You may qualify if:

  • patients age \> 18 years
  • Diagnosis of heart failure NYHA class II- IV
  • LVEF ≤ 40% on echocardiography

You may not qualify if:

  • Estimated glomerular filtration rate \<30 ml/min/1.73m2
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

cardiology department at Ain Shams university hospitals

Cairo, Egypt

Location

Related Publications (4)

  • Coronel R, de Groot JR, van Lieshout JJ. Defining heart failure. Cardiovasc Res. 2001 Jun;50(3):419-22. doi: 10.1016/s0008-6363(01)00284-x. No abstract available.

    PMID: 11376615BACKGROUND

  • Lam CSP, Gamble GD, Ling LH, Sim D, Leong KTG, Yeo PSD, Ong HY, Jaufeerally F, Ng TP, Cameron VA, Poppe K, Lund M, Devlin G, Troughton R, Richards AM, Doughty RN. Mortality associated with heart failure with preserved vs. reduced ejection fraction in a prospective international multi-ethnic cohort study. Eur Heart J. 2018 May 21;39(20):1770-1780. doi: 10.1093/eurheartj/ehy005.

    PMID: 29390051BACKGROUND

  • McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.

    PMID: 31535829BACKGROUND

  • Rahmoune H, Thompson PW, Ward JM, Smith CD, Hong G, Brown J. Glucose transporters in human renal proximal tubular cells isolated from the urine of patients with non-insulin-dependent diabetes. Diabetes. 2005 Dec;54(12):3427-34. doi: 10.2337/diabetes.54.12.3427.

    PMID: 16306358BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

February 5, 2023

First Posted

February 14, 2023

Study Start

September 1, 2021

Primary Completion

January 28, 2024

Study Completion

February 1, 2024

Last Updated

January 29, 2024

Record last verified: 2024-01

Locations

EG(1)