Last updated on December 2019

Safety Tolerability and Efficacy of Rapid Optimization Helped by NT-proBNP and GDF-15 of Heart Failure Therapies


Brief description of study

STRONG-HF is a multicenter, randomized, parallel group study designed to evaluate the efficacy and safety of up-titration of standard oral heart failure medications during hospitalization for acute heart failure. Patients admitted for acute heart failure will be randomized 1-2 days before discharge to either usual care or intensification of treatment with a beta-blocker, a renin-angiotensin system blocker, and a mineralocorticoid receptor blocker ("high intensity care" arm). In the "high intensity care" arm, patients' clinical signs and symptoms of heart failure will be assessed, and routine laboratory measures and biomarkers will be measured, at frequent post-discharge visits. When these measures indicate that it is safe to do so, the doses of the oral heart failure medications will be increased to optimal levels. Patients will be followed through 90 days from randomization. Patients assigned to the usual care group will be followed by their general physician and/or cardiologist according to local medical standards. All patients, including those who were screened but did not meet eligibility criteria, will be followed for 90-day outcome.

Detailed Study Description

STRONG-HF is a multicenter, randomized, parallel group study designed to evaluate the efficacy and safety of up-titration of standard of care medical therapy including beta-blockers; angiotensin converting enzyme inhibitors (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor neprolysin inhibitor (ARNi); and mineralocorticoid receptor antagonist (MRAs), on morbidity and mortality when initiated and up-titrated early during hospitalization for acute heart failure (AHF). Optimal safety conditions will allow physicians to introduce and/or continue oral HF therapies during this "vulnerable phase" in AHF patients. Patients admitted for AHF with clinical signs of congestion and elevated circulating N-terminal pro-B-type natriuretic peptide (NT-proBNP) and who are not treated with optimal doses of oral heart failure (HF) therapies 1-2 days before hospital discharge for AHF and who are hemodynamically stable will be randomized in a 1:1 ratio to either usual care (named "usual care" arm) or intensification of treatment with beta-blockers, and ACEi (or ARB) or ARNi and a MRA (named "high intensity care" arm). In the latter arm, repeated assessments of clinical signs and symptoms of heart failure, routine clinical laboratory measures including potassium, sodium, and creatinine as well as biomarkers including NT-ProBNP and growth differentiation factor 15 (GDF-15) will foster, encourage and ensure the safety of the optimization of oral heart failure therapies. Patients will be followed through 90 days from randomization. AHF patients who were screened but did not meet inclusion criteria, including low circulating NT-proBNP at visit 2, will also be followed for 90-day outcome.

Clinical Study Identifier: NCT03412201

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