Estudio Internacional, Multicéntrico, de Grupos Paralelos... | EligiMed

Estudio Internacional, Multicéntrico, de Grupos Paralelos, Aleatorizado, Doble Ciego, Controlado con Placebo de Fase III para Evaluar el Efecto de Dapagliflozin sobre la Capacidad de Ejercicio en Pacientes con Insuficiencia Cardíaca con Fracción de Eyección Preservada

CompletadoFase 3ClinicalTrials.gov

ID: NCT03877224Tipo: INTERVENTIONALInicio: 4 de abr de 2019Fin estimado: 9 de jul de 2020

Resumen

Estudio internacional, multicéntrico, de grupos paralelos, aleatorizado, doble ciego y controlado con placebo de Fase III para evaluar el efecto de dapagliflozin sobre la capacidad de ejercicio en pacientes con insuficiencia cardíaca con fracción de eyección preservada (ICFEp).

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 150 YearsSexo: ALL

Criterios de inclusión

Provision of signed informed consent prior to any study specific procedures
Male or female, aged ≥40 years
Established documented diagnosis of symptomatic HFpEF (NYHA functional class II-IV), which has been present for at least 8 weeks
LVEF\>40% and evidence of structural heart disease
Elevated NT-proBNP levels
Patients should receive background standard of care as described below: All patients will be treated according to locally recognised guidelines on standard of care treatment for patients with HFpEF. Therapy should have been individually optimised and stable for ≥4 weeks (this does not apply to diuretics) and include (unless contraindicated or not tolerated) treatment of co morbidities (including high blood pressure, ischaemic heart disease, atrial fibrillation/flutter).
MWD≥100 metres and ≤425 metres at enrolment and randomization

Criterios de exclusión

Presence of any condition that precludes exercise testing
Participation in a structured exercise training programme in the 1 month prior to screening or planned to start during the trial
Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
Type 1 diabetes mellitus
eGFR \<25 mL/min/1.73 m2 (CKD-EPI formula) at enrolment, unstable or rapidly progressing renal disease at time of randomisation
Systolic BP \<95 mmHg on 2 consecutive measurements
Systolic BP ≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements
Current acute decompensated HF or hospitalisation due to decompensated HF \<4 weeks prior to enrolment
MI, unstable angina, coronary revascularization ablation of atrial fibrillation/flutter, valve repair/replacement, implantation of a cardiac resynchronization therapy device within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization.
Stroke or transient ischemic attack within 12 weeks prior to enrolment.
Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD.
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
HF due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular disease

Intervenciones

drug

Dapagliflozin

Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks.

other

Placebo

Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks.

Ubicaciones

Research Site

CABA, Argentina

Research Site

Ciudad Autonoma de Buenos Aire, Argentina

Research Site

Ciudad Autonomade Buenos Aires, Argentina

Patrocinadores

PrincipalAstraZeneca

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