Proof-of-concept study of Empagliflozin in patients with pulmonary arterial hypertension (EmPAH)

Conditions

Pulmonary arterial hypertension

Brief summary

Difference in the S´/RAAi ratio (measured by echocardiography) from baseline to week 4.

Detailed description

• Echocardiography (RA Area, TAPSE/PASP, pericardial effusion, S´/RAAi) • cMRI (RV EF, SVI, RVESVI, PA flow for impedance calculation, RV and LV EDV, RV and LV ESV, RV and LS SV, RV and LV EF, RV and LV CO, RV and LV CO, RV and LV Myocardial Mass, LVEDVI, LVESVI, LVMI, RV and LV GLS, RV and LV T1, RV and LV T2, RV and LV GLE, PA Flow and Aortic Flow) • pulmonary hemodynamics via Swan-Ganz catheterization (mPAP, dPAP, sPAP, PAWP, cardiac output by Fick (direct or indirect), PVR, SvO2, CVP/RAP, Ca, • body plethysmography • FEV1, FEV1%pred, FVC, FVCpred, TLC%pred, DLCO%pred, FVC obs.v., FEV1 obs.v., TLC obs. V., TLC%pred, RV obs. V., VC obs. V., DLCO, sRaw effektiv, • Blood gas analysis: Capillary pO2, Capillary pCO2, • Six minutes walking distance (6MWD) • BNP • CPET (VO2 and VE/VCO2 slope, as well as WHO FC), • Patient-reported outcome measures (PAH-Sympact, MLC questionnaire, EQ-5D-5L Mobility Score), • Adverse event (AE), Serious (S) AE assessment

Related papers

No related papers found yet.

Interventions

DRUGEmpagliflozin

DRUGPlacebo (HPMC) capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Difference in the S´/RAAi ratio (measured by echocardiography) from baseline to week 4.	—

Secondary

Measure	Time frame
• Echocardiography (RA Area, TAPSE/PASP, pericardial effusion, S´/RAAi) • cMRI (RV EF, SVI, RVESVI, PA flow for impedance calculation, RV and LV EDV, RV and LV ESV, RV and LS SV, RV and LV EF, RV and LV CO, RV and LV CO, RV and LV Myocardial Mass, LVEDVI, LVESVI, LVMI, RV and LV GLS, RV and LV T1, RV and LV T2, RV and LV GLE, PA Flow and Aortic Flow) • pulmonary hemodynamics via Swan-Ganz catheterization (mPAP, dPAP, sPAP, PAWP, cardiac output by Fick (direct or indirect), PVR, SvO2, CVP/RAP, Ca, • body plethysmography • FEV1, FEV1%pred, FVC, FVCpred, TLC%pred, DLCO%pred, FVC obs.v., FEV1 obs.v., TLC obs. V., TLC%pred, RV obs. V., VC obs. V., DLCO, sRaw effektiv, • Blood gas analysis: Capillary pO2, Capillary pCO2, • Six minutes walking distance (6MWD) • BNP • CPET (VO2 and VE/VCO2 slope, as well as WHO FC), • Patient-reported outcome measures (PAH-Sympact, MLC questionnaire, EQ-5D-5L Mobility Score), • Adverse event (AE), Serious (S) AE assessment	—

Measure

Time frame

• Echocardiography (RA Area, TAPSE/PASP, pericardial effusion, S´/RAAi) • cMRI (RV EF, SVI, RVESVI, PA flow for impedance calculation, RV and LV EDV, RV and LV ESV, RV and LS SV, RV and LV EF, RV and LV CO, RV and LV CO, RV and LV Myocardial Mass, LVEDVI, LVESVI, LVMI, RV and LV GLS, RV and LV T1, RV and LV T2, RV and LV GLE, PA Flow and Aortic Flow) • pulmonary hemodynamics via Swan-Ganz catheterization (mPAP, dPAP, sPAP, PAWP, cardiac output by Fick (direct or indirect), PVR, SvO2, CVP/RAP, Ca, • body plethysmography • FEV1, FEV1%pred, FVC, FVCpred, TLC%pred, DLCO%pred, FVC obs.v., FEV1 obs.v., TLC obs. V., TLC%pred, RV obs. V., VC obs. V., DLCO, sRaw effektiv, • Blood gas analysis: Capillary pO2, Capillary pCO2, • Six minutes walking distance (6MWD) • BNP • CPET (VO2 and VE/VCO2 slope, as well as WHO FC), • Patient-reported outcome measures (PAH-Sympact, MLC questionnaire, EQ-5D-5L Mobility Score), • Adverse event (AE), Serious (S) AE assessment

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Countries

Germany

Outcome results

None listed