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Table 4 Primary and secondary study outcomes

From: The LIFT trial: study protocol for a double-blind, randomised, placebo-controlled trial of K+-binder Lokelma for maximisation of RAAS inhibition in CKD patients with heart failure

Objectives

Outcome measures

Timepoints of evaluation

Primary Objective:

To compare SZC vs placebo with respect to:

Enabling participants to achieve target RAASi dose while keeping serum potassium < 5.6 mmol/L.

Blood test for potassium and RAASi dose

Secondary Objectives:

To compare SZC vs placebo with respect to:

Achieving maximum dose of MRA and ACEi/ARB with serum potassium < 5.6 mmol/L

Achieving maximum dose of MRA and ACEi/ARB with serum potasssium < 6.0 mmol/L

Time since randomisation to first occurrence of hyperkalaemia (serum potassium ≥5.6 mmol/L)

Time since randomisation to severe hyperkalaemia (serum potassium ≥6.0 mmol/L)

Number of ACEi/ARB, MRA dose changes

Number and durationof hospital admissions during the study

Change in serum potassium at respective visits vs baseline

Blood test for potassium and RAASi dose ever two weeks. Other parameters checked at baseline and end of study.

Tertiary Objectives:

None

  1. Table 4—Primary and secondary study outcomes