Effect of Flozin (dapagliflozin) Administration on Myocardial and Peripheral Vascular Remodeling (DAPA-REMO)

November 5, 2024 updated by: Arkadiusz Niklas, Poznan University of Medical Sciences
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

In the available literature, there are reports of beneficial effects of flozins on improving myocardial systolic and diastolic function and isolated reports of effects on regression of organ damage (heart, vessels). These drugs significantly improve the prognosis of patients with heart failure, reduce total and cardiovascular mortality, reduce the number of exacerbations and the need for hospitalization, and have a beneficial effect on improving quality of life regardless of coexisting diabetes. New properties demonstrating the pleiotropic effect of the flozins are constantly being discovered. Drugs in this group are highly potent, selective and reversible inhibitors of the sodium ion-dependent glucose cotransporter 2 (SGLT2). The flozins have a low risk of side effects.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Arkadiusz Niklas, MD PhD
  • Phone Number: 0048 61 854 90 90
  • Email: aniklas@ump.edu.pl

Study Locations

  • Poland
    • Wielkopolska
      • Poznan, Wielkopolska, Poland, 60-355
        • Recruiting
        • University Clinical Hospital in Poznań, 49 Przybyszewskiego Street, 60-355 Poznań
        • Contact:
          • Arkadiusz Niklas, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify factors that predict remodeling and enhancement of left ventricular (LV) systolic and diastolic function within 12 months.
Time Frame: 6 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the combined outcome including deaths from cardiovascular causes, defibrillator discharges, hospitalizations or episodes of atrial fibrillation.
Time Frame: Baseline ut to 12 months
Over 12 months, the study will assess a combined outcome including cardiovascular-related deaths, defibrillator discharges, hospitalizations, or atrial fibrillation episodes. Predictors for these cardiovascular events will be analyzed using univariate and multivariate Cox analyses, with the model's quality evaluated by time-dependent ROC analysis.
Baseline ut to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poznan University of Medical Sciences

Investigators

  • Principal Investigator: Arkadiusz Niklas, PhD, University Clinical Hospital in Poznań, 49 Przybyszewskiego Street, 60-355 Poznań

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2023

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Estimated)

November 7, 2024

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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