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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyperkalemia

In brief

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

Key facts

Study ID

NCT03888066

Run by

Vifor Pharma, Inc.

People needed

1195

Starts

2019-04-24

Expected to finish

2021-09-02

Last updated by the study team

2023-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Investigator Site 11-041 — Huntsville, Alabama, United States
• Investigator Site 11-153 — Phoenix, Arizona, United States
• Investigator Site 11-097 — Tucson, Arizona, United States
• Investigator Site 11-052 — Bakersfield, California, United States
• Investigator Site 11-174 — Fremont, California, United States
• Investigator Site 11-136 — Fresno, California, United States
• Investigator Site 11-102 — Huntington Beach, California, United States
• Investigator Site 11-162 — La Jolla, California, United States
• Investigator Site 11-048 — La Mesa, California, United States
• Investigator Site 11-111 — Laguna Hills, California, United States
• Investigator Site 11-017 — Long Beach, California, United States
• Investigator Site 11-128 — Northridge, California, United States
• Investigator Site 11-035 — Pasadena, California, United States
• Investigator Site 11-044 — Sacramento, California, United States
• Investigator Site 11-135 — San Diego, California, United States
• Investigator Site 11-086 — San Diego, California, United States
• Investigator Site 11-112 — Santa Ana, California, United States
• Investigator Site 11-101 — Stockton, California, United States
• Investigator Site 11-047 — Thousand Oaks, California, United States
• Investigator Site 11-057 — Van Nuys, California, United States
• Investigator Site 11-058 — West Hills, California, United States
• Investigator Site 11-095 — Aurora, Colorado, United States
• Investigator Site 11-168 — Altamonte Springs, Florida, United States
• Investigator Site 11-106 — Boynton Beach, Florida, United States
• Investigator Site 11-080 — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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