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. 2023 Apr 26;5(7):537–544. doi: 10.1016/j.cjco.2023.04.004

Table 1.

Exclusion criteria

  • 1.

    Participation in a clinical trial of an investigational drug, concurrently, or within the last 30 days prior to enrollment

  • 2.

    Planned cardiac surgery (eg, severe tricuspid regurgitation with planned tricuspid valve replacement or repair)

  • 3.

    Previous cardiac transplantation, or on heart transplant wait list

  • 4.

    Myocardial infarction, stroke, or open-heart surgery in the previous 4 weeks

  • 5.

    New York Heart Association functional class I or IV symptoms

  • 6.

    Symptomatic hypotension (fainting, dizziness, lightheadedness, blurred vision, weakness, fatigue, nausea, palpitations, and headache) with a systolic blood pressure < 100 mm Hg at screening, or asymptomatic with pressure < 90 mm Hg at screening

  • 7.

    eGFR < 30 mL/min per 1.73 m2

  • 8.

    Reduction in eGFR > 35% from screening to randomization

  • 9.

    Potassium > 5.2 mmol/L at screening or > 5.4 mmol/L at randomization

  • 10.

    Known history of angioedema related to previous ACEi or ARB therapy or patients with a history of hereditary or idiopathic angioedema

  • 11.

    Patients who require concomitant treatment with an ACEi or an ARB or a renin inhibitor for an indication other than heart failure

  • 12.

    Evidence of hepatic disease as determined by any one of the following: SGOT (AST) or SGPT (ALT) values exceeding 3x the upper limit of normal, bilirubin > 1.5 mg/dL at screening.

  • 13.

    Unacceptable side effects with ACEis or ARBs

  • 14.

    Patient with known bilateral renal artery stenosis

  • 15.

    Cyanosis; substantial left-to-right shunting (Qp/Qs > 1.5); severe mitral, aortic, or pulmonary regurgitation; systemic or pulmonary inflow obstruction with a peak velocity > 1.5 m/s by transthoracic echocardiography; and severe outflow tract obstruction with a peak systolic gradient > 80 mm Hg.

  • 16.

    Inability to provide informed consent

  • 17.

    Unable to exercice

  • 18.

    Pregnant or planned pregnancy during the study

  • 19.

    Breastfeeding

  • 20.

    Severe pulmonary hypertension defined as pulmonary pressure equal or superior to systemic pressure

ACEi, angiotensin-converting enzyme inhibitor; ALT, alanine aminotransferase; ARB, angiotensin receptor blocker; AST, aspartate aminotransferase; eGFR, estimated glomerular filtration rate; Qp/Qs, ratio of pulmonary blood flow to systemic blood flow; SGOT, serum glutamic-oxaloacetic transaminase; SGPT, serum glutamic pyruvic transferase.