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

NCT ID: NCT03888066

Last Updated: 2023-02-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2021-09-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Hyperkalemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective Phase 3b multinational, multicenter, double-blind, placebo-controlled, randomized withdrawal, parallel group study that includes screening and 12 weeks Run-in Phase and a randomized withdrawal Blinded Treatment Phase.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1: Patiromer

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

Group Type EXPERIMENTAL

Patiromer

Intervention Type 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).

Group 2: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type 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).

Interventions

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Patiromer

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).

Intervention Type DRUG

Placebos

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).

Intervention Type DRUG

Other Intervention Names

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Veltassa

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Syneos Health

OTHER

Sponsor Role collaborator

Vifor Pharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Szecsödy, MD

Role: STUDY_DIRECTOR

Vifor Pharma

Locations

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Investigator Site 11-080

Alexander City, Alabama, United States

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Investigator Site 11-041

Huntsville, Alabama, United States

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Investigator Site 11-153

Phoenix, Arizona, United States

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Investigator Site 11-097

Tucson, Arizona, United States

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Bakersfield, California, United States

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Investigator Site 11-174

Fremont, California, United States

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Fresno, California, United States

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Investigator Site 11-102

Huntington Beach, California, United States

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La Jolla, California, United States

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La Mesa, California, United States

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Laguna Hills, California, United States

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Long Beach, California, United States

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Investigator Site 11-128

Northridge, California, United States

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Pasadena, California, United States

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Investigator Site 11-044

Sacramento, California, United States

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Investigator Site 11-135

San Diego, California, United States

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Investigator Site 11-086

San Diego, California, United States

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Santa Ana, California, United States

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Investigator Site 11-101

Stockton, California, United States

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Thousand Oaks, California, United States

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Investigator Site 11-057

Van Nuys, California, United States

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West Hills, California, United States

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Aurora, Colorado, United States

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Investigator Site 11-168

Altamonte Springs, Florida, United States

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Investigator Site 11-106

Boynton Beach, Florida, United States

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Brandon, Florida, United States

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Doral, Florida, United States

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Gainesville, Florida, United States

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Investigator Site 11-164

Greenacres City, Florida, United States

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Homestead, Florida, United States

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Investigator Site 11-004

Jacksonville, Florida, United States

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Investigator Site 11-179

Jacksonville, Florida, United States

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Medley, Florida, United States

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Miami, Florida, United States

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Investigator Site 11-125

Miami, Florida, United States

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Investigator Site 11-005

Miami, Florida, United States

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Research Site 11-001

Miami Lakes, Florida, United States

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Research Site 11-002

Miami Lakes, Florida, United States

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Investigator Site 11-032

North Miami Beach, Florida, United States

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Investigator Site 11-171

Orlando, Florida, United States

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Investigator Site 11-025

Orlando, Florida, United States

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Investigator Site 11-087

Orlando, Florida, United States

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Investigator Site 11-177

Pembroke Pines, Florida, United States

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Investigator Site 11-144

Pompano Beach, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Macon, Georgia, United States

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Arlington Heights, Illinois, United States

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Hazel Crest, Illinois, United States

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Peoria, Illinois, United States

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Peoria, Illinois, United States

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Merrillville, Indiana, United States

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Munster, Indiana, United States

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Richmond, Indiana, United States

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Owensboro, Kentucky, United States

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Opelousas, Louisiana, United States

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West Monroe, Louisiana, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Livonia, Michigan, United States

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Rochester, Michigan, United States

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Rochester, Michigan, United States

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Jackson, Mississippi, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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North Las Vegas, Nevada, United States

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Haddon Heights, New Jersey, United States

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Linden, New Jersey, United States

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New Brunswick, New Jersey, United States

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Newark, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Brooklyn, New York, United States

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Buffalo, New York, United States

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Manhasset, New York, United States

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Richmond Hill, New York, United States

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Staten Island, New York, United States

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Stony Brook, New York, United States

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The Bronx, New York, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Greenville, North Carolina, United States

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Lumberton, North Carolina, United States

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Columbus, Ohio, United States

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Lorain, Ohio, United States

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Marion, Ohio, United States

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Toledo, Ohio, United States

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Bartlesville, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Hillsboro, Oregon, United States

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Portland, Oregon, United States

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Erie, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Greenville, South Carolina, United States

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Greenwood, South Carolina, United States

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Lancaster, South Carolina, United States

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Rock Hill, South Carolina, United States

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Chattanooga, Tennessee, United States

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Jackson, Tennessee, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Tullahoma, Tennessee, United States

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Allen, Texas, United States

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Allen, Texas, United States

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Amarillo, Texas, United States

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Dallas, Texas, United States

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Denison, Texas, United States

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Fort Worth, Texas, United States

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Gonzales, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Katy, Texas, United States

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Lampasas, Texas, United States

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McKinney, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Webster, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Norfolk, Virginia, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

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Ciudadela, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Ramos Mejía, Buenos Aires, Argentina

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San Nicolás de los Arroyos, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Córdoba, Córdoba Province, Argentina

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Córdoba, Córdoba Province, Argentina

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Villa María, Córdoba Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Salta, , Argentina

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San Luis, , Argentina

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Santa Fe, , Argentina

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Mechelen, Antwerp, Belgium

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Ghent, Oost Vlaanderen, Belgium

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Aalst, , Belgium

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Brussels, , Belgium

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Genk, , Belgium

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Hasselt, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Roeselare, , Belgium

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Yvoir, , Belgium

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Fortaleza, Ceará, Brazil

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Fortaleza, Ceará, Brazil

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Vitória, Espírito Santo, Brazil

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Salvador, Estado de Bahia, Brazil

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Brasília, Federal District, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Uberlândia, Minas Gerais, Brazil

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Campina Grande do Sul, Paraná, Brazil

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Canoas, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Blumenau, Santa Catarina, Brazil

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Aracaju, Sergipe, Brazil

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Campinas, São Paulo, Brazil

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Ribeirão Preto, São Paulo, Brazil

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São José do Rio Preto, São Paulo, Brazil

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Rio de Janeiro, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Investigator Site 61-003

Burgas, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Investigator Site 12-005

Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Investigator Site 12-008

Cambridge, Ontario, Canada

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London, Ontario, Canada

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Newmarket, Ontario, Canada

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Toronto, Ontario, Canada

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Investigator Site 12-009

Greenfield Park, Quebec, Canada

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Investigator Site 12-006

Sherbrooke, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Investigator Site 62-004

Bílina, , Czechia

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Brno, , Czechia

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Havířov, , Czechia

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Havlíčkův Brod, , Czechia

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Liberec, , Czechia

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Litovel, , Czechia

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Mariánské Lázně, , Czechia

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Náchod, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Slaný, , Czechia

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Uherské Hradiště, , Czechia

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Bordeaux, , France

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La Tronche, , France

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Lille, , France

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Lyon, , France

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Montpellier, , France

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Nancy, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Pau, , France

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Poitiers, , France

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Reims, , France

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Rouen, , France

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Saint-Brieuc, , France

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Toulon, , France

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Toulouse, , France

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Tourcoing, , France

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Valenciennes, , France

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Valenciennes, , France

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Batumi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Coburg, Bavarian, Germany

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Greifswald, Mecklenburg-Vorpommern, Germany

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Homburg, Saarland, Germany

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Bad Oeynhausen, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Bremen, , Germany

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Erfurt, , Germany

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Essen, , Germany

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Frankfurt, , Germany

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Frankfurt, , Germany

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Giessen, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Heilbronn, , Germany

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Kiel, , Germany

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Leipzig, , Germany

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Leverkusen, , Germany

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Minden, , Germany

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Nuremberg, , Germany

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Würzburg, , Germany

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Kecskemét, , Hungary

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Kistarcsa, , Hungary

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Nyíregyháza, , Hungary

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Ashkelon, , Israel

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Be’er Ya‘aqov, , Israel

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Hadera, , Israel

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Haifa, , Israel

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Haifa, , Israel

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Holon, , Israel

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Jerusalem, , Israel

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Jerusalem, , Israel

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Jerusalem, , Israel

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Nahariya, , Israel

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Petah Tikva, , Israel

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Ramat Gan, , Israel

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Safed, , Israel

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Tiberias, , Israel

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Ancona, , Italy

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Bergamo, , Italy

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Brescia, , Italy

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Caserta, , Italy

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Cona, , Italy

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Foggia, , Italy

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Genova, , Italy

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Milan, , Italy

Site Status

Investigator Site 34-012

Piacenza, , Italy

Site Status

Investigator Site 34-003

Roma, , Italy

Site Status

Investigator Site 34-013

San Bonifacio, , Italy

Site Status

Investigator Site 23-012

Guadalajara, Jalisco, Mexico

Site Status

Investigator Site 23-004

Guadalajara, Jalisco, Mexico

Site Status

Investigator Site 23-007

Cuauhtémoc, Mexico City, Mexico

Site Status

Investigator Site 23-005

Gustavo Adolfo Madero, Mexico City, Mexico

Site Status

Investigator Site 23-010

San Pedro Garza García, Nuevo Léon, Mexico

Site Status

Investigator Site 23-011

Oaxaca City, Oaxaca, Mexico

Site Status

Investigator Site 23-001

Querétaro City, Querétaro, Mexico

Site Status

Investigator Site 23-002

Culiacán, Sinaloa, Mexico

Site Status

Investigator Site 23-006

Xalapa, Veracruz, Mexico

Site Status

Investigator Site 36-003

Rotterdam, South Holland, Netherlands

Site Status

Investigator Site 36-002

's-Hertogenbosch, , Netherlands

Site Status

Investigator Site 36-012

Amstelveen, , Netherlands

Site Status

Investigator Site 36-006

Blaricum, , Netherlands

Site Status

Investigator Site 36-009

Dirksland, , Netherlands

Site Status

Investigator Site 36-015

Dordrecht, , Netherlands

Site Status

Investigator Site 36-007

Ede, , Netherlands

Site Status

Investigator Site 36-001

Groningen, , Netherlands

Site Status

Investigator Site 36-013

Helmond, , Netherlands

Site Status

Investigator Site 36-014

Hoorn, , Netherlands

Site Status

Investigator Site 36-010

Schiedam, , Netherlands

Site Status

Investigator Site 36-004

Tilburg, , Netherlands

Site Status

Investigator Site 36-011

Utrecht, , Netherlands

Site Status

Investigator Site 65-007

Bialystok, , Poland

Site Status

Investigator Site 65-014

Katowice, , Poland

Site Status

Investigator Site 65-012

Kędzierzyn-Koźle, , Poland

Site Status

Investigator Site 65-001

Lodz, , Poland

Site Status

Investigator Site 65-018

Lodz, , Poland

Site Status

Investigator Site 65-019

Olsztyn, , Poland

Site Status

Investigator Site 65-015

Ostrowiec Świętokrzyski, , Poland

Site Status

Investigator Site 65-021

Pomorskie, , Poland

Site Status

Investigator Site 65-003

Poznan, , Poland

Site Status

Investigator Site 65-020

Poznan, , Poland

Site Status

Investigator Site 65-008

Rzeszów, , Poland

Site Status

Investigator Site 65-010

Wroclaw, , Poland

Site Status

Investigator Site 65-005

Wroclaw, , Poland

Site Status

Investigator Site 65-011

Zgierz, , Poland

Site Status

Investigator Site 66-014

Izhevsk, Udmurt Republic, Russia

Site Status

Investigator Site 66-008

Chelyabinsk, , Russia

Site Status

Investigator Site 66-016

Kazan', , Russia

Site Status

Investigator Site 66-010

Kemerovo, , Russia

Site Status

Investigator Site 66-015

Moscow, , Russia

Site Status

Investigator Site 66-004

Moscow, , Russia

Site Status

Investigator Site 66-011

Moscow, , Russia

Site Status

Investigator Site 66-017

Moscow, , Russia

Site Status

Investigator Site 66-002

Novosibirsk, , Russia

Site Status

Investigator Site 66-005

Penza, , Russia

Site Status

Investigator Site 66-007

Perm, , Russia

Site Status

Investigator Site 66-012

Petrozavodsk, , Russia

Site Status

Investigator Site 66-018

Ryazan, , Russia

Site Status

Investigator Site 66-013

Saint Petersburg, , Russia

Site Status

Investigator Site 66-003

Saint Petersburg, , Russia

Site Status

Investigator Site 66-009

Tver', , Russia

Site Status

Investigator Site 66-001

Yekaterinburg, , Russia

Site Status

Investigator Site 67-010

Belgrade, , Serbia

Site Status

Investigator Site 67-002

Belgrade, , Serbia

Site Status

Investigator Site 67-004

Belgrade, , Serbia

Site Status

Investigator Site 67-008

Belgrade, , Serbia

Site Status

Investigator Site 67-001

Kamenitz, , Serbia

Site Status

Investigator Site 67-005

Niš, , Serbia

Site Status

Investigator Site 67-007

Niška Banja, , Serbia

Site Status

Investigator Site 67-003

Šabac, , Serbia

Site Status

Investigator Site 37-014

Palma de Mallorca, Balearic Islands, Spain

Site Status

Investigator Site 37-010

Castellon, Castellon, Spain

Site Status

Investigator Site 37-003

Barcelona, Catalonia, Spain

Site Status

Investigator Site 37-005

Santiago de Compostela, La Coruña, Spain

Site Status

Investigator Site 37-011

Majadahonda, Madrid, Spain

Site Status

Investigator Site 37-024

Marbella, Malaga, Spain

Site Status

Investigator Site 37-016

San Cristóbal de La Laguna, Tenerife, Spain

Site Status

Investigator Site 37-001

Manises, Valencia, Spain

Site Status

Investigator Site 37-025

A Coruña, , Spain

Site Status

Investigator Site 37-012

Alicante, , Spain

Site Status

Investigator Site 37-015

Badalona, , Spain

Site Status

Investigator Site 37-007

Barcelona, , Spain

Site Status

Investigator Site 37-002

Barcelona, , Spain

Site Status

Investigator Site 37-018

Huelva, , Spain

Site Status

Investigator Site 37-023

Lleida, , Spain

Site Status

Investigator Site 37-004

Madrid, , Spain

Site Status

Investigator Site 37-006

Madrid, , Spain

Site Status

Investigator Site 37-021

Madrid, , Spain

Site Status

Investigator Site 37-020

Madrid, , Spain

Site Status

Investigator Site 37-026

Madrid, , Spain

Site Status

Investigator Site 37-017

Málaga, , Spain

Site Status

Investigator Site 37-022

Murcia, , Spain

Site Status

Investigator Site 37-013

Seville, , Spain

Site Status

Investigator Site 37-009

Valencia, , Spain

Site Status

Investigator Site 37-008

Valencia, , Spain

Site Status

Investigator Site 68-008

Kharkiv, Novobavarskiy, Ukraine

Site Status

Investigator Site 68-017

Dnipro, , Ukraine

Site Status

Investigator Site 68-009

Ivano-Frankivsk, , Ukraine

Site Status

Investigator Site 68-005

Ivano-Frankivsk, , Ukraine

Site Status

Investigator Site 68-001

Kharkiv, , Ukraine

Site Status

Investigator Site 68-011

Kharkiv, , Ukraine

Site Status

Investigator Site 68-010

Kharkiv, , Ukraine

Site Status

Investigator Site 68-002

Kharkiv, , Ukraine

Site Status

Investigator Site 68-012

Kyiv, , Ukraine

Site Status

Investigator Site 68-003

Kyiv, , Ukraine

Site Status

Investigator Site 68-015

Kyiv, , Ukraine

Site Status

Investigator Site 68-013

Kyiv, , Ukraine

Site Status

Investigator Site 68-007

Kyiv, , Ukraine

Site Status

Investigator Site 68-006

Lviv, , Ukraine

Site Status

Investigator Site 68-014

Vinnytsia, , Ukraine

Site Status

Investigator Site 68-016

Zaporizhzhya, , Ukraine

Site Status

Investigator Site 68-004

Zhytomyr, , Ukraine

Site Status

Investigator Site 39-012

Harlow, Essex, United Kingdom

Site Status

Investigator Site 39-003

Scunthorpe, North Lincolshire, United Kingdom

Site Status

Investigator Site 39-005

Dudley, West Midlands, United Kingdom

Site Status

Investigator Site 39-009

Barnsley, , United Kingdom

Site Status

Investigator Site 39-016

High Wycombe, , United Kingdom

Site Status

Investigator Site 39-008

Inverness, , United Kingdom

Site Status

Investigator Site 39-011

Leicester, , United Kingdom

Site Status

Investigator Site 39-013

Liverpool, , United Kingdom

Site Status

Investigator Site 39-015

London, , United Kingdom

Site Status

Investigator Site 39-010

North Shields, , United Kingdom

Site Status

Investigator Site 39-007

Swansea, , United Kingdom

Site Status

Investigator Site 39-004

York, , United Kingdom

Site Status

Countries

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United States Argentina Belgium Brazil Bulgaria Canada Czechia France Georgia Germany Hungary Israel Italy Mexico Netherlands Poland Russia Serbia Spain Ukraine United Kingdom

References

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Coats AJS, Anker SD, Lund LH, Filippatos G, Rossignol P, Pitt B, Weir MR, Kosiborod MN, Metra M, Bohm M, Ezekowitz JA, Bayes-Genis A, Mentz RJ, Ponikowski P, Senni M, Cleland JGF, Goudev A, Khintibidze I, Lindenfeld J, Merkely B, Waechter S, Budden J, Perrin A, Butler J. Patiromer for Heart Failure Medication Optimization in Patients With Current or Past Hyperkalemia: DIAMOND Subanalysis. JACC Heart Fail. 2024 Dec;12(12):2026-2037. doi: 10.1016/j.jchf.2024.08.003. Epub 2024 Sep 25.

Reference Type DERIVED
PMID: 39340493 (View on PubMed)

Butler J, Anker SD, Lund LH, Coats AJS, Filippatos G, Siddiqi TJ, Friede T, Fabien V, Kosiborod M, Metra M, Pina IL, Pinto F, Rossignol P, van der Meer P, Bahit C, Belohlavek J, Bohm M, Brugts JJ, Cleland JGF, Ezekowitz J, Bayes-Genis A, Gotsman I, Goudev A, Khintibidze I, Lindenfeld J, Mentz RJ, Merkely B, Montes EC, Mullens W, Nicolau JC, Parkhomenko A, Ponikowski P, Seferovic PM, Senni M, Shlyakhto E, Cohen-Solal A, Szecsody P, Jensen K, Dorigotti F, Weir MR, Pitt B. Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial. Eur Heart J. 2022 Nov 1;43(41):4362-4373. doi: 10.1093/eurheartj/ehac401.

Reference Type DERIVED
PMID: 35900838 (View on PubMed)

Bolanos JA, Seliger SL. Recurrent Hyperkalemia in Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) Treatment: Stuck between a Rock and a Hard Place. Clin J Am Soc Nephrol. 2021 Mar 8;16(3):345-347. doi: 10.2215/CJN.00950121. Epub 2021 Feb 19. No abstract available.

Reference Type DERIVED
PMID: 33608263 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2018-005030-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PAT-CR-302

Identifier Type: -

Identifier Source: org_study_id

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