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

NCT ID: NCT06679179

Last Updated: 2024-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-10

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Arkadiusz Niklas

Poznan University of Medical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arkadiusz Niklas, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Poznan, Wielkopolska, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Arkadiusz Niklas, MD PhD

Role: CONTACT

0048 61 854 90 90

Facility Contacts

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Arkadiusz Niklas, MD PhD

Role: primary

Other Identifiers

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199/23

Identifier Type: -

Identifier Source: org_study_id

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