STRONG-HF: the biomarker-led post-acute heart failure treatment strategy you might have been waiting for¹

The STRONG-HF study was a multinational, open-label, randomised clinical trial, designed to assess the safety and efficacy of rapid up-titration of treatments, biomarker-led (including NT-pro-BNP), after acute heart failure, as compared to usual care.¹

87 hospitals¹, 14 countries¹

After enrolling more than 1000 patients, the data and safety monitoring board of the study recommended early termination of the study because of greater than expected between-group differences, implying that intensive follow-up with rapid up-titration of GDMT are clinically significant after admission to hospital for acute heart failure¹.

Heart failure affects more than 64 million people. A prevalence that is almost two thirds that of all cancers combined.² The mortality rate for chronic heart failure is ~50% at 5 years post-diagnosis,³ with survival rates worse than major cancers, such as, bowel, breast and prostate cancer.⁴

It is the leading cause of hospitalisation around the world;⁵ and despite considerable advancements in cardiac care, the readmission rates for heart failure have not improved since the 1980s.^6,7

In the 60–90 days after hospital discharge, 30% of patients with heart failure are readmitted and 15% die.⁹ Approximately half of all patients are readmitted within 6 months of first hospitalisation.⁸ Therefore, when it comes to GDMT optimisation for patients following acute heart failure, time is of the essence.^1,10

Hospital discharge and post-discharge care often deviate from best-practice recommendations.¹¹ Indeed, many patients with heart failure never receive target doses of GDMT.^6,12

The STRONG-HF biomarker-led therapeutic strategy offers guidance on rapid initiation and optimisation of GDMT during the vulnerable period after heart failure; thereby supporting you in providing optimal, life-saving treatment when it is needed the most.¹

Inclusion criteria:

• Hospital admission within the 72 hours prior to screening for acute heart failure with dyspnoea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as oedema and/or positive rales on auscultation
• All measures within 24 hours prior to randomisation of systolic blood pressure ≥100 mmHg and of heart rate ≥60 bpm
• All measures within 24 hours prior to randomisation of serum potassium ≤5.0 mEq/L (mmol/L)
• Biomarker criteria for persistent congestion:
  • At screening, NT-proBNP >2,500 pg/mL
  • At the time of randomisation (within 2 days prior to discharge), NT-proBNP >1,500 pg/mL (to ensure the persistence of congestion) that has decreased by more than 10% compared to screening (to ensure the acuity of the index episode)
• At 1 week prior to admission, at screening and at Visit 2 (just prior to randomisation) either
  • ≤ ½ the optimal dose of ACEi/ARB/ARNi prescribed, no beta blocker prescribed and ≤½ the optimal dose of MRA prescribed or
  • No ACEi/ARB/ARNi prescribed, ≤½ the optimal dose of beta blocker prescribed and ≤ ½ the optimal dose of MRA prescribed
• Written informed consent to participate in the study

Exclusion criteria:

• Age <18 or >85 years
• Clearly documented intolerance to high doses of beta blockers
• Clearly documented intolerance to high doses of RAS blockers (both ACEi and ARB)
• Mechanical ventilation (not including CPAP/BiPAP) in the 24 hours prior to screening
• Significant pulmonary disease contributing substantially to the patient’s dyspnoea such as FEV1 <1 L or need for chronic systemic or non-systemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism
• Myocardial infarction, unstable angina or cardiac surgery within 3 months, or CRT device implantation within 3 months, or PCI within 1 month prior to screening
• Index event (admission for AHF) triggered primarily by a correctable aetiology such as significant arrhythmia (e.g. sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response >130 bpm, or bradycardia with sustained ventricular arrhythmia <45 bpm), infection, severe anaemia, acute coronary syndrome, pulmonary embolism, exacerbation of COPD, planned admission for device implantation or severe non-adherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not an exclusion
• Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy
• History of heart transplant or on a transplant list, or using or plan to be implanted with a ventricular assist device
• Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated
• Presence at screening of any haemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation, or the presence of any haemodynamically significant obstructive lesion of the left ventricular outflow tract
• Active infection at any time during the AHF hospitalisation prior to randomisation based on abnormal temperature and elevated WBC count need for intravenous antibiotics
• Stroke or TIA within the 3 months prior to screening 
• Primary liver disease considered to be life threatening
• Renal disease or eGFR <30 mL/min/1.73 m2 (as estimated by the simplified MDRD formula) at screening or history of dialysis
• Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy <6 months
• Prior (defined as <30 days from screening) or current enrolment in a CHF trial or participation in an investigational drug or device study within the 30 days prior to screening
• Discharge for the AHF hospitalisation anticipated to be >14 days from admission, or to a long-term care facility. Randomisation must occur within 12 days following admission and within 2 days prior to anticipated discharge
• Inability to comply with all study requirements due to major comorbidities, social or financial issues, or a history of non-compliance with medical regimens, that might compromise the patient’s ability to understand and/or comply with the protocol instructions or follow-up procedures
• Pregnant or nursing (lactating) women

You can now implement the STRONG-HF biomarker-led therapeutic strategy in your own practice and drive the same positive results for your patients with acute heart failure.¹