. 2020 Apr 15;7(3):856–864. doi: 10.1002/ehf2.12694

Table 1.

Key eligibility criteria of the PARALLAX trial

Inclusion criteria
• Male or female aged ≥45 years • LVEF >40% and structural heart disease demonstrated by left atrial enlargement or left ventricular hypertrophy on echocardiography at screening or within 6 months prior to screening • Current symptom(s) of HF (NYHA class II–IV) at screening and requiring treatment with diuretics for at least 30 days prior to screening • NT‐proBNP >220 pg/mL for patients with no atrial fibrillation/flutter or >600 pg/mL for those with atrial fibrillation/flutter on electrocardiogram (ECG) at screening • Receiving evidence‐based therapy for relevant co‐morbidities with stable doses for the previous 4 weeks prior to randomization • KCCQ Clinical Summary Score <75 at screening • Patients on ACEi or ARB therapy must have a history of hypertension
Exclusion criteria
• Any prior echocardiographic measurement of LVEF ≤40%, under stable conditions • Acute decompensated HF within 30 days prior to screening, or acute coronary syndrome (including myocardial infarction), cardiac surgery, other major CV surgery, or urgent percutaneous coronary intervention within 3 months prior to screening • Any clinical event within the 6 months prior to screening that could have reduced the LVEF, unless an echo measurement was performed after the event confirming the LVEF to be >40% • Walk distance primarily limited by non‐cardiac conditions at screening • Probable alternate diagnosis of the HF symptoms • Prior history of any dilated cardiomyopathy, including peripartum cardiomyopathy, chemotherapy induced cardiomyopathy, or viral myocarditis • Patients with HbA1c > 7.5%, not treated for diabetes • SBP <110 mmHg or ≥ 180 mmHg at screening • SBP >150 to <180 mmHg at screening unless the patient is receiving three or more antihypertensive drugs • Serum potassium >5.2 mmol/L (or equivalent plasma potassium value) at screening • eGFR <30 mL/min/1.73m² at screening

Inclusion criteria

• Male or female aged ≥45 years

• LVEF >40% and structural heart disease demonstrated by left atrial enlargement or left ventricular hypertrophy on echocardiography at screening or within 6 months prior to screening

• Current symptom(s) of HF (NYHA class II–IV) at screening and requiring treatment with diuretics for at least 30 days prior to screening

• NT‐proBNP >220 pg/mL for patients with no atrial fibrillation/flutter or >600 pg/mL for those with atrial fibrillation/flutter on electrocardiogram (ECG) at screening

• Receiving evidence‐based therapy for relevant co‐morbidities with stable doses for the previous 4 weeks prior to randomization

• KCCQ Clinical Summary Score <75 at screening

• Patients on ACEi or ARB therapy must have a history of hypertension

Exclusion criteria

• Any prior echocardiographic measurement of LVEF ≤40%, under stable conditions

• Acute decompensated HF within 30 days prior to screening, or acute coronary syndrome (including myocardial infarction), cardiac surgery, other major CV surgery, or urgent percutaneous coronary intervention within 3 months prior to screening

• Any clinical event within the 6 months prior to screening that could have reduced the LVEF, unless an echo measurement was performed after the event confirming the LVEF to be >40%

• Walk distance primarily limited by non‐cardiac conditions at screening

• Probable alternate diagnosis of the HF symptoms

• Prior history of any dilated cardiomyopathy, including peripartum cardiomyopathy, chemotherapy induced cardiomyopathy, or viral myocarditis

• Patients with HbA1c > 7.5%, not treated for diabetes

• SBP <110 mmHg or ≥ 180 mmHg at screening

• SBP >150 to <180 mmHg at screening unless the patient is receiving three or more antihypertensive drugs

• Serum potassium >5.2 mmol/L (or equivalent plasma potassium value) at screening

• eGFR <30 mL/min/1.73m² at screening

ACEi, angiotensin‐converting enzyme inhibitor; ARB, angiotensin II receptor blocker; CV, cardiovascular; ECG electrocardiogram; eGFR, estimated glomerular filtration rate; HbA1c, glycated haemoglobin; HF, heart failure; KCCQ, Kansas City Cardiomyopathy Questionnaire; LVEF, left ventricular ejection fraction; NT‐proBNP, N‐terminal pro BNP; NYHA, New York Heart Association; SBP, systolic blood pressure