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

Vifor

Status and phase: Completed; Phase 3

Conditions: Hyperkalemia

Treatments: Drug: Placebos; Drug: Patiromer

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03888066

2018-005030-38 (EudraCT Number)

PAT-CR-302

Details and patient eligibility

About

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

Full description

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

The study population includes subjects with heart failure (HF) 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 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 (variable per subject). Study duration for individual subjects will vary, depending on their individual enrollment date. Subjects who prematurely discontinue patiromer/placebo will remain in the study for the collection of clinical events data and will receive usual care.

Enrollment: 1,195 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age at least 18 years or greater
• Symptomatic low ejection fraction heart failure (weak heart muscle)
• Receiving any dose of a beta blocker for the treatment of HF (unless not able to tolerate)
• Kidney function not more than mild or moderately impaired
• High blood potassium (>5.0 mEq/L) currently while receiving medications for heart failure OR normal blood potassium currently but previously had high potassium in the12 months prior to screening which caused a permanent reduction or discontinuation of heart failure medications
• Hospitalization for heart failure or treatment in an out patient setting with intravenous medications within the last 12 months before screening.

Exclusion criteria

• Current acute decompensated HF, within 4 weeks before screening. Subjects with a discharge from a hospitalization for acute decompensation of HF longer than 4 weeks before screening may be included
• Significant primary aortic or mitral valvular heart disease (except secondary mitral regurgitation due to left ventricular dilatation)
• Heart transplantation or planned heart transplantation (i.e., currently on a heart transplant waiting list) during the study period

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,195 participants in 2 patient groups, including a placebo group

Group 1: Patiromer

Experimental group

Description:

Subjects will be randomized to receive a daily dose of patiromer with possible dose adjustments based on subsequent local serum potassium levels.

Treatment:

Drug: Patiromer

Group 2: Placebo

Placebo Comparator group

Description:

Subjects will be randomized to receive a daily dose of placebo with possible dose adjustments based on subsequent local serum potassium levels.

Treatment:

Drug: Placebos