An interventional study of Usual Care and High Intensity Care in Heart Failure, sponsored by Heart Initiative. Status unknown at 78 sites in 12 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-02-12.
Sponsored by Heart Initiative · Not applicable, Interventional, and Treatment
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 within 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 180 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. Patients who were screened but did not meet eligibility criteria will be followed for 90-day outcome. Randomized patients will be contacted at 180 days to assess outcomes.
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 within 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 NT-ProBNP will foster, encourage and ensure the safety of the optimization of oral heart failure therapies. AHF patients who were screened but did not meet inclusion criteria, including low circulating NT-proBNP at visit 2, will be followed for 90-day outcome. Randomized patients will be contacted at 180 days to assess outcomes.
Exclusion Criteria:
Follow-up and management of heart failure medications provided by the patient's general physician and/or cardiologist according to local medical standards
Other: Usual Care
Follow-up and management of heart failure medications provided by specialists at participating institutions. Doses of oral heart failure medications optimized within 2 weeks, provided clinical assessments and laboratory measures indicate that it is safe to increase doses.
Other: High Intensity Care
Follow-up and management of heart failure medications provided by the patient's general physician and/or cardiologist according to local medical standards
Follow-up and management of heart failure medications provided by specialists at participating institutions. Doses of oral heart failure medications optimized within 2 weeks, provided clinical assessments and laboratory measures indicate that it is safe to increase doses.
180-day all-cause mortality or heart failure readmission
Cumulative risk of either readmission for heart failure or death at 180 days
Time frame: 180 days
Change in quality of life
Change from baseline to 90 days in quality of life as measured using the EQ-5D visual analogue scale (VAS) which ranges from 0 to 100 with a higher score representing a better outcome. "EQ-5D" is the official name of a quality of life instrument developed by EuroQol.
Time frame: 90 days
180-day all-cause mortality
Cumulative risk of death at 180 days
Time frame: 180 days
90-day all-cause mortality or heart failure readmission
Cumulative risk of either readmission for heart failure or death at 90 days
Time frame: 90 days
180-day cardiovascular death
Cumulative risk of death due to cardiovascular cause at 180 days
Time frame: 180 days
90-day cardiovascular death
Cumulative risk of death due to cardiovascular cause at 90 days
Time frame: 90 days
90-day all-cause mortality
Cumulative risk of death at 90 days
Time frame: 90 days
180-day heart failure readmission
Cumulative risk of readmission for heart failure at 180 days
Time frame: 180 days
90-day heart failure readmission
Cumulative risk of readmission for heart failure at 90 days
Time frame: 90 days
Finkelstein-Schoenfeld hierarchical composite
Hierarchical composite endpoint comprising death, heart failure readmissions, and EQ-VAS analyzed using Finkelstein-Schoenfeld methodology
Time frame: 90 days
Change in NT-proBNP
Change from baseline to 90 days in NT-proBNP on the log scale
Time frame: 90 days
Change in weight
Change from baseline to 90 days in weight in kg
Time frame: 90 days
Changes in signs and symptoms of congestion: NYHA class
Changes from baseline to 90 days in New York Heart Association (NYHA) class which ranges from 1 to 4 with a higher class representing a worse outcome
Time frame: 90 days
Changes in signs and symptoms of congestion: orthopnea
Changes from baseline to 90 days in orthopnea rated on a scale from 0 to 3 with a higher score representing a worse outcome
Time frame: 90 days
Changes in signs and symptoms of congestion: peripheral edema
Changes from baseline to 90 days in peripheral edema rated on a scale from 0 to 3 with a higher score representing a worse outcome
Time frame: 90 days
Changes in signs and symptoms of congestion: rales
Changes from baseline to 90 days in rales rated on a scale from 0 to 3 with a higher score representing a worse outcome
Time frame: 90 days
Changes in signs and symptoms of congestion: JVP
Changes from baseline to 90 days in jugular venous pulse (JVP) rated on a scale from 1 to 4 with a higher score representing a worse outcome
Time frame: 90 days
Plan to share: Undecided
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