Last updated on March 2020

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

Brief description of study

The purpose of this study is to determine if patiromer treatment of subjects who developed hyperkalemia while receiving RAASi medications will result in continued use of RAASi medications in accordance with heart failure (HF) treatment guidelines and thereby decrease the occurrence of the combined endpoint of cardiovascular (CV) death and CV hospitalization events compared with placebo treatment.

Detailed Study Description

Phase 3b multinational, multicenter, double-blind, placebo-controlled, randomized withdrawal, parallel group study that includes screening and 12 weeks Run-in Phase (where RAASi medications, including mineralocorticoid receptor antagonist (MRA) will be optimized for all subjects) and a randomized withdrawal Blinded Treatment Phase.

Subjects with heart failure with reduced ejection fraction (HFrEF) who are hyperkalemic (serum potassium [K+] > 5.0 mEq/L) while receiving treatment with renin angiotensin aldosterone system inhibitor (RAASi) medications or who are normokalemic (serum K+ 4.0 - 5.0 mEq/L) but have a history of hyperkalemia in the 12 months prior to screening with subsequent reduction or discontinuation of a RAASi medication

Each subject's participation includes a Run-in Phase (maximum 12 weeks) followed by the Treatment Phase (anticipated to be at least 6 months per subject). The study will continue until the required number of composite endpoint events have occurred. Study duration for individual subjects will vary, depending on the rate of occurrence of composite endpoint events. Given the assumptions underlying the study design, accumulation of the requisite number of composite endpoint events is expected to occur over approximately 2.5 years. Subjects who prematurely discontinue patiromer/placebo will remain in the study for the collection of composite endpoint event data and will receive usual care.

Clinical Study Identifier: NCT03888066

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Investigator Site 11-020

Bradenton, FL United States
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