NCT05778084

Brief Summary

This study aims to evaluate the relationship between NT-proBNP and empagliflozin effects in patients with chronic heart failure with mildly reduced ejection fraction (HFmrEF 41-49%) and reduced ejection fraction (HFrEF ≤40%) whether diabetic or non-diabetic patients.

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
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2022

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

December 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

March 21, 2023

Status Verified

October 1, 2022

Enrollment Period

1.5 years

First QC Date

March 9, 2023

Last Update Submit

March 9, 2023

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

EmpagliflozinHeart failure with reduced ejection fractionNt-proBNP

Outcome Measures

Primary Outcomes (1)

  • NT-ProBNP

    Measuring of serum N-terminal Pro-B-type Natriuretic Peptide at baseline and after 6 months

    6 months

Secondary Outcomes (6)

  • Hemoglobin level g/dl

    6 months

  • Leukocytes count

    6 months

  • Sodium level mg/dl

    6 months

  • Potassium level mg/dl

    6 months

  • Serum Creatinine

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Heart failure patients with reduced and mildly reduced ejection fraction

OTHER

* One paired test group described as Heart Failure patients with reduced and mildly reduced ejection fraction are indicated for Empagliflozin. * Blood samples will be collected as a baseline before Empagliflozin administration to test for N-terminal Pro-B-type Natriuretic Peptide, * Followed by administration of empagliflozin for 6 months. * Then retest the N-terminal Pro-B-type Natriuretic Peptide after 6 months.

Drug: Empagliflozin 10 MG

Interventions

Empagliflozin 10 MGDRUG

Blood samples will be collected as a baseline to test for N-terminal Pro-B-type Natriuretic Peptide, followed by administration of empagliflozin for 6 months, and then another blood samples will be collected after 6 months.

Heart failure patients with reduced and mildly reduced ejection fraction

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic heart failure with mildly reduced ejection fraction (41-49%) and reduced ejection fraction (≤40%)
  • years
  • Not receiving empagliflozin or any SGLT2 inhibitor
  • Elevated plasma NT-proBNP (≥125 pg/ml)
  • eGFR ≥ 20 ml/min/1.73m2

You may not qualify if:

  • Acute Coronary Syndrome (ACS)
  • Pulmonary embolism
  • Myocarditis
  • Valvular heart disease
  • Hypertrophic or restrictive cardiomyopathy
  • Congenital heart disease
  • Pulmonary hypertension
  • Surgical procedures involving the heart
  • Heart contusion
  • Cardioversion, Implantable Cardioverter Defibrillator (ICD) shock
  • Patients receiving digoxin
  • Advanced age (\>70years)
  • Ischemic stroke
  • Chronic Obstructive Pulmonary Disease
  • Subarachnoid haemorrhage
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University

Alexandria, 21521, Egypt

RECRUITING

MeSH Terms

Interventions

empagliflozin

Central Study Contacts

Rabab Y Kosba, PharmD

CONTACT

01227609096gs-rabab.kosba@alexu.edu.eg

Noha A Hamdy, PHD

CONTACT

01005182151Noha.alaaeldine@alexu.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open labelled interventional study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 21, 2023

Study Start

December 15, 2022

Primary Completion

June 15, 2024

Study Completion

December 15, 2024

Last Updated

March 21, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)