Trial · NCT06619600
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Extracellular volume (ECV, %) | 6 months | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the extracellular volume (ECV) of the remote myocardium between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔECV dapagliflozin group versus ΔECV placebo group; \[ΔECV = ECV 6-month - ECV baseline\]). |
| Secondary | Serum levels of C-terminal propeptide of type I procollagen (PICP) | 6 months | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of C-terminal propeptide of type I procollagen (PICP) between the 6-month and baseline follow- up (ΔPICP dapagliflozin group versus ΔPICP placebo group; \[ΔPICP = PICP 6-month - PICP baseline\]). |
| Secondary | N-terminal propeptide of type III (PIIINP) | 6 months | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of N-terminal propeptide of type III (PIIINP) between the 6-month and baseline follow- up (ΔPIIINP dapagliflozin group versus ΔPIIINP placebo group; \[ΔPIIINP = PIIINP 6-month - PIIINP baseline\]). |
| Secondary | Galectin-3 procollagen (Gal-3) | 6 months | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of galectin-3 procollagen (Gal-3) between the 6-month and baseline follow- up (ΔGal-3 dapagliflozin group versus ΔGal-3 placebo group; \[ΔGal-3 = Gal-3 6-month - Gal-3 baseline\]). |
| Secondary | High-Sensitivity cardiac Troponin I (hs-cTnI) | 6 months | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of High-Sensitivity cardiac Troponin I (hs-cTnI) between the 6-month and baseline follow- up (hs-cTnI dapagliflozin group versus hs-cTnI placebo group; \[Δhs-cTnI = hs-cTnI 6-month - hs-cTnI baseline\]). |
| Other | N-terminal pro-brain natriuretic peptide (NT-proBNP) | 6 months | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) between the 6-month and baseline follow- up (NT-proBNP dapagliflozin group versus NT-proBNP placebo group; \[ΔNT-proBNP = NT-proBNP 6-month - NT-proBNP baseline\]). |
| Other | Soluble suppression of tumorigenicity 2 (sST2) | 6 months | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of Soluble suppression of tumorigenicity 2 (sST2) between the 6-month and baseline follow- up (sST2 dapagliflozin group versus sST2 placebo group; \[ΔsST2 = sST2 6-month - sST2 baseline\]). |
| Other | Indexed ventricular mass of the left ventricle (LVMI, g/m^2) | 6 months | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the Indexed ventricular mass of the left ventricle (LVMI) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔLVMI dapagliflozin group versus ΔLVMI placebo group; \[ΔLVMI = LVMI 6-month - LVMI baseline\]). |
| Other | Indexed End-diastolic volume of the left ventricle (LVEDVI, mL/m^2) | 6 months | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the Indexed End-diastolic volume of the left ventricle (LVEDVI) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔLVEDVI dapagliflozin group versus ΔLVEDVI placebo group; \[ΔLVEDVI = LVEDVI 6-month - LVEDVI baseline\]). |
| Other | Indexed End-systolic volume of the left ventricle (LVESVI, mL/m^2) | 6 months | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the Indexed End-systolic volume of the left ventricle (LVESVI) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔLVESVI dapagliflozin group versus ΔLVESVI placebo group; \[ΔLVESVI = LVESVI 6-month - LVESVI baseline\]). |
| Other | Left ventricular ejection fraction (LVEF, %) | 6 months | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the Left ventricular ejection fraction (LVEF) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔLVEF dapagliflozin group versus ΔLVEF placebo group; \[ΔLVEF = LVEF 6-month - LVEF baseline\]). |
| Other | Body weight (BW, Kgs) | 6 months | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the Body weight (BW) between the 6-month and baseline follow- up, (ΔBW dapagliflozin group versus ΔBW placebo group; \[ΔBW = BW 6-month - BW baseline\]). |
| Other | Major Adverse Cardiovascular Events (MACE) | 6 months | Difference in the incidence of Major Adverse Cardiovascular Events (MACE), defined as a composite of death, non-fatal myocardial infarction, and non-fatal stroke, between the dapagliflozin and placebo groups. |
| Other | Hospitalizations for Heart Failure (HHF) | 6 months | Difference in the incidence of Hospitalizations for Heart Failure (HHF) between the dapagliflozin and placebo groups. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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