NCT06679179

Brief Summary

The aim of this study is to assess the effect of treatment with flozin (dapagliflozin 10mg once a day) on haemodynamic parameters and myocardial and peripheral vascular remodeling in patients with NYHA class II-III heart failure.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

November 7, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

November 5, 2024

Last Update Submit

November 5, 2024

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Identify factors that predict remodeling and enhancement of left ventricular (LV) systolic and diastolic function within 12 months.

    This study aims to identify factors that predict the remodeling and enhancement of left ventricular (LV) systolic and diastolic functions over 12 months. Using both univariate and multivariate logistic regression analyses, it will focus on finding predictors at the 6-month mark, especially through advanced echocardiography parameters and vascular stiffness test.

    6 months

Secondary Outcomes (1)

  • Assessment of the combined outcome including deaths from cardiovascular causes, defibrillator discharges, hospitalizations or episodes of atrial fibrillation.

    Baseline ut to 12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients over 18 years of age of both sexes with diagnosed heart failure NYHA class II and III.

You may qualify if:

  • diagnosed heart failure NYHA class II and III
  • consent to participate in the study
  • patients should already be receiving treatment with an ACE inhibitor or sacubitril/valsartan or sartans, a beta-blocker, and an MRA, and should start on SGLT2i as part of therapy enhancement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Hospital in Poznań, 49 Przybyszewskiego Street, 60-355 Poznań

Poznan, Wielkopolska, 60-355, Poland

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Arkadiusz Niklas, PhD

    University Clinical Hospital in Poznań, 49 Przybyszewskiego Street, 60-355 Poznań

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arkadiusz Niklas, MD PhD

CONTACT

0048 61 854 90 90aniklas@ump.edu.pl

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Poznan University of Medical Sciences

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 7, 2024

Study Start

March 10, 2023

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

November 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)