Efficacy of a Streamlined Heart Failure Optimization Protocol

Other illness

• Type 1 diabetes mellitus
• Cognitive impairment that in the opinion of the investigator may lead the patient to be unable to understand and/or comply with the study medications, procedures and/or follow-up
• Uncorrected primary valvular disease
• Active malignancy treatment at time of visit 1
• History of angioedema, or hereditary or idiopathic angioedema
• Severe hepatic impairment, biliary cirrhosis or cholestasis

Lab values

• Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2
• Patients who are receiving treatment with an aliskiren-containing product who have diabetes mellitus or renal impairment (eGFR \<60 ml/min/1.73 m2)
  • Highly effective methods of contraception include implants, injectables, combined oral contraceptives (the participant must have been on a stable dose for at least 3 months before entering the trial), intrauterine device, vasectomised partner, or true sexual abstinence (when this is the preferred and usual lifestyle of the patient and does not include periodic abstinence \[e.g. calendar, ovulation, symptothermal or post-ovulation methods\]). Use of such methods must be maintained throughout the trial and for 7 days after the end of the trial.

Other

• Systolic BP of less than 100 mmHg on 2 consecutive measurements
• Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is reliable in the judgement of the investigator\*
• Women who are pregnant or breastfeeding

• Ejection fraction of less than or equal to 40%
• Increased NT-proBNP level:
• ≥ 600 pg per milliliter or
• ≥400 pg per milliliter if they had been hospitalized for heart failure within the previous 12 months or
• patients with atrial fibrillation or atrial flutter on baseline electrocardiography were required to have an NT-pro BNP level of at least 900 pg per milliliter, regardless of their history of hospitalization for heart failure or
• recent heart failure admission or clinical diagnosis of heart failure.
• Patients who are either naïve to or taking no more than 25% target doses of Beta Blockers or ACEi or ARB before starting the trial.