Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)

Conditions

• Hyperkalemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Patiromer — DRUG
  The starting dose of patiromer will be 1 packet/day and may be taken either with food or without food. Based upon the patiromer treatment algorithm patiromer may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, patiromer may be decreased to a minimum of 0 packets/day. Doses of patiromer will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).
• Placebos — DRUG
  The starting dose of placebo will be 1 packet/day and may be taken either with food or without food. Based upon the placebo treatment algorithm placebo may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, placebo may be decreased to a minimum of 0 packets/day. Doses of placebo will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).

Study Details

The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.

Key Dates

Start date

Apr 24, 2019

Status verified

Feb 2023

Primary completion

Sep 2, 2021

Completion

Sep 2, 2021

Study Design

Enrollment

1,195 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Group 1: Patiromer
  Subjects will be randomized to receive a daily dose of patiromer with possible dose adjustments based on subsequent local serum potassium levels.
• Placebo Comparator: Group 2: Placebo
  Subjects will be randomized to receive a daily dose of placebo with possible dose adjustments based on subsequent local serum potassium levels.

Primary Outcome Measure

Changes in Serum K+ Levels From Baseline [ Time Frame: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo ]

Locations (133)

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