Phase 3
Completed N=1,195
Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
Source: ClinicalTrials.gov NCT03888066 ↗Enrolled (actual)
1,195
Serious AEs
12.8%
Results posted
Feb 2023
Primary outcomePrimary: Changes in Serum K+ Levels From Baseline — 0.029; 0.127 Milliequivalents Per Liter (mEq/l) — p=< 0.001
◆ Published Evidence
Highly cited
223citations · ~56 / year
Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial.
Summary
The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.
Linked Publications (4)
-
Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial.
-
Patiromer for Heart Failure Medication Optimization in Patients With Current or Past Hyperkalemia: DIAMOND Subanalysis.
-
Patiromer-Facilitated Renin-Angiotensin-Aldosterone System Inhibitor Utilization in Patients with Heart Failure with or without Comorbid Chronic Kidney Disease: Subgroup Analysis of DIAMOND Randomized Trial.
-
Recurrent Hyperkalemia in Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) Treatment: Stuck between a Rock and a Hard Place.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Serum K+ Levels From Baseline |
0.029; 0.127 | < 0.001 sig |
| SECONDARY CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time |
0.02; 0.04; 0.04; 0.08; 0.05; 0.10 | = 0.006 sig |
| SECONDARY CIF Estimates of the Reduction of the MRA Dose Below Target Dose Over Time |
0.02; 0.04; 0.03; 0.08; 0.06; 0.12 | = 0.006 sig |
| SECONDARY Investigator-reported Events of Hyperkalemia |
82.38; 114.65 | < 0.001 sig |
| SECONDARY Hyperkalemia-related Hard Outcomes Endpoints |
3491; 4609; 4539; 4178; 419; 401 | <0.001 sig |
| SECONDARY RAASi Use Score |
62073; 49733; 80915; 192721 | = 0.048 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03888066) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.