Win Ratio DIAMOND Clinical Trial 2022 Results

Win Ratio Diamond Clinical Trial – Overview

The patiromer for managing hyperkalemia in subjects receiving RAASi medications for the treatment of heart failure (DIAMOND) clinical trial is sponsored by Vifor Pharma, Inc. in collaboration with Syneos Health, LLC.

Aim of DIAMOND Trial

This study aims to evaluate the effects of patiromer compared to placebo on serum K+ in HF patients. This study is a multi-national, multi-center, randomized withdrawal, double-blind, placebo-controlled, parallel-group study. It includes screening and around 12 weeks of the Run-in Phase. Subjects have patiromer-initiated and RAASi medications and a randomized withdrawal Blinded Treatment Phase.

The study participants include subjects suffering from heart failure (HF) with reduced ejection fraction (HFrEF) who are also hyperkalemia (serum potassium K+) while receiving treatment with renin angiotensin aldosterone system inhibitor (RAASi) medications.

However, the study also evaluated participants who are normokalemic but have experienced hyperkalemia prior to the screening, with significant continuation or reduction for a RAASi medication.

Every participant is subjected to a Run-in Phase of a maximum of 12 weeks followed by the Treatment Phase, which varies for every participant. Therefore, every participant’s study duration also varies, depending on their individual enrolment date.

Study Design

Study type – Interventional (clinical trial)

Actual enrolment – 878 participants

Allocation – Randomized

Interventional model – Parallel Assignment

Masking – Quadruple (Participant, Investigator, Care Provider, Outcomes Assessor)

Primary aim – Intervention

Outcome Measures

Win Ratio DIAMOND Clinical Trial – Outcome Measures

The primary outcome measure was the mean change from baseline in serum K+ levels. The secondary outcome measures involved time to the first event of hyperkalemia with a serum K+ value >5.5 mEq/L.

The durable enablement was allowed to stay on the MRA target dose of 50 mg daily and the time to the event of reduction of the MRA dose was below target. The investigator reported adverse events of hyperkalemia. The hyperkalemia-related hard outcome endpoints were analyzed using the Win Ratio approach with the following hierarchical elements:

Time to CV (cardiovascular) death
Number of CV hospitalizations overall
Total number of hyperkalemia toxicity events with serum K+ >6.5 mEq/L
Total number of hyperkalemia events with serum K+ >6.0 – 6.5 mEq/L
Total number of hyperkalemia events with serum K+ >5.0 mEq/L

The RAASi use score was determined by analyzing the Win Ratio approach for each pair of participants with the following additional components:

All-cause of death
Occurrence of a CV hospitalization
HF medications use and dose for an ACEi/ARB/ARNi, and MRA along with a beta-blocker

Every participant in each comparison is to have 0 to 8 points, and all participants are compared using this score at the right follow-up point in time.

Eligibility Criteria

The eligibility criteria for this clinical study require participants to be:

At least 18 years or more of age
Receive a dose of beta-blocker for treating HF
Symptomatic low ejection fraction heart failure (weak heart muscle)
Kidney function not more than moderate or mildly impaired
High blood potassium (>5.0 mEq/L) patients currently getting medications for heart failure
Hospitalization for heart failure or treatment in an outpatient setting with intravenous medications within at least 12 months before screening
Current acute decompensated HF, within four weeks before screening
Subjects with a discharge letter from hospitalization for acute de-compensation of HF lasting for over four weeks before screening
Noticeable primary mitral valvular or aortic heart disease
Heart transplantation or planned heart transplantation

Conclusion

This study was conducted at around 415 locations across the United States. This study aims to study an FDA-approved drug product and agrees to share study findings if they receive a research proposal approved by an independent review panel and the study sponsor and researchers agree to sign a data-sharing agreement.

To find more details about Win Ratio Diamond clinical trial, you can access the official entry at https://www.clinicaltrials.gov/ct2/show/NCT03888066.

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