Personalised Prospective Comparison of ARni With ArB in Patients With Natriuretic Peptide eLEvation (NCT04687111) | Clinical Trial Compass
UnknownPhase 2
Personalised Prospective Comparison of ARni With ArB in Patients With Natriuretic Peptide eLEvation
Ireland250 participantsStarted 2015-12-16
Plain-language summary
Sacubitril-valsartan, an Angiotensin Receptor Blocker-Neprilysin Inhibitor (ARNI), currently marketed for the management of heart failure, has been shown to reduce cardiovascular morbidity and mortality in stage C heart failure with reduced ejection fraction. In stage C HFpEF, sacubitril-valsartan has also been shown to reduce left atrial volume index measured using echocardiography over a 9 month timeframe. The PARABLE study investigates the hypothesis that sacubitril-valsartan can provide benefits in terms of left atrial structure and function as well as left ventricular structure and function in asymptomatic (stage A/B HFpEF) patients. This is a prospective, randomised, double-blind, double-dummy, phase II study design. The patient population will have hypertension and/or diabetes together with preserved ejection fraction, elevated natriuretic peptide (NP) and abnormal left atrial volume index (LAVI, \> 28 mL/m2).
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. Age \> 40yrs with cardiovascular risk factor(s) including at least one of:
✓. History of hypertension (medicated for greater than one month);
✓. History of diabetes;
✓. Elevated NP: Elevated NP: BNP between 20 and 280pg/ml or NT-proBNP values between 100 pg/ml and 1,000 pg/ml within 6 months prior to screening or at screening
✓. LAVI \> 28 mL/m2 obtained during Doppler Echocardiography within 6 months prior to screening or at screening
✓. Subjects must give written informed consent to participate in the study and before any study related assessments are performed.
Exclusion criteria
✕. A history of heart failure.
✕. Asymptomatic left ventricular systolic dysfunction defined as LVEF \<50% on most recent measurement.
✕. History of hypersensitivity, allergy or intolerance to LCZ696, ARB or neprilysin therapy or to any of the excipients or other contraindication to their use.
✕. Previous history of intolerance to recommended target doses for ARBs
✕. Subjects who require treatment with both an ACE inhibitor and an ARB
✕. Presence of haemodynamically significant mitral and /or aortic valve disease.