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Completed

NCT Number: NCT03888066

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

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

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Key information

Conditions

Hyperkalemia Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Hypertension Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigator Site 21-006, Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patiromer

Drug

The starting dose of patiromer will be 1 packet/day and may be taken either with food or without food. Based upon the patiromer treatment algorithm patiromer may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, patiromer may be decreased to a minimum of 0 packets/day. Doses of patiromer will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).

Other names: Veltassa

Placebos

Drug

The starting dose of placebo will be 1 packet/day and may be taken either with food or without food. Based upon the placebo treatment algorithm placebo may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, placebo may be decreased to a minimum of 0 packets/day. Doses of placebo will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).

Primary outcomes

  1. Changes in Serum K+ Levels From Baseline

    Time frame: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo

    Adjusted mean changes in serum K+ from Baseline.

Secondary outcomes

  1. CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time

    Time frame: From Day 1/Baseline to week 90

    Cumulative incidence of the first event of hyperkalemia with a serum K+ value >5.5 mEq/l taking death as competing and calculated as CIF Estimates (95% CI) over time.

    Aalen-Johansen estimators of the cumulative incidence function with death as a competing event.

    CIF = cumulative incidence function; mEq/l = Milliequivalents Per Liter

  2. CIF Estimates of the Reduction of the MRA Dose Below Target Dose Over Time

    Time frame: From Day 1/Baseline to week 102

    Cumulative incidence of the reduction of the MRA dose below target dose calculated as CIF Estimates (95% CI) over time.

    Note: The reduction below the MRA target dose must last for at least 14 days (orless if at the end of study) to confirm this endpoint.

    CIF = cumulative incidence function; mEq/l = Milliequivalents Per Liter

  3. Investigator-reported Events of Hyperkalemia

    Time frame: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo

    Participant's follow-up is from the date of the first dose of randomized study medication up to the participant's end of study date or 24 Jun 2021, whichever comes first.

    Annualized event rate per 100 subject-years= The total number of events for all subjects in the treatment group divided by the total subject-years of follow-up in that treatment group multiplied by 100.

  4. Hyperkalemia-related Hard Outcomes Endpoints

    Time frame: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo

    Analyzed using Win Ratio approach with the following hierarchical components:

    • Time to CV death
    • Total number of CV hospitalizations
    • 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

    MHTE=More hyperkalemia toxicity events; MHE=More hyperkalemia events; CV=Cardiovascular

  5. RAASi Use Score

    Time frame: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo

    RAASi use score (0 to 8 points) analyzed using the Win Ratio approach for each pair of participants with the following additive components:

    • All-cause death
    • Occurrence of a CV hospitalization
    • HF medication use and dose for i) an ACEi/ARB/ARNi, ii) a MRA, and iii) a beta-blocker

    Each participant in each comparison can have 0-8 points and all participants are compared using this score at the respective appropriate follow-up time point.

    RAASi=renin-angiotensin-aldosterone system inhibitor; ACEi=angiotensin converting enzyme inhibitor; ARB=angiotensin receptor blocker; ARNi=angiotensin receptor/neprilysin inhibitor; MRA=mineralocorticoid receptor antagonist.

Sponsors and collaborators

Lead sponsor

Vifor Pharma, Inc.

Industry

Collaborators

  • Syneos Health

Registry information

Official study title

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin Angiotensin Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)

Acronym: DIAMOND

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 25, 2019
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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