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) - DIAMOND

Relypsa Inc0 sites878 target enrollmentJanuary 22, 2021

Overview

No summary available.

Registry

who.int

Start Date

January 22, 2021

End Date

September 2, 2021

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Subject provides written informed consent prior to study participation
•2\. Age at least 18 years or greater
•3\. History of New York Heart Association (NYHA) Class II–IV HF
•4\. Left ventricular ejection fraction \<40%, measured by any echocardiographic, radionuclide, or computerized tomography method in the last 12 months
•without subsequent measured ejection fraction \=40% during this interval)
•5\. Receiving any dose of a beta blocker (BB) for the treatment of HF or unable to tolerate BB (reason documented)
•6\.Estimated glomerular filtration rate (eGFR) \=30 mL/min/1\.73 m2 at Screening (based on a single local laboratory calculation using the Chronic Kidney
•Disease Epidemiology Collaboration (CKD\-EPI) equation; see Section 9\.2 of the protocol)
•7\. Hyperkalemia at Screening (defined by 2 local serum K\+ values of \>5\.0 mEq/L each obtained from a separate venipuncture, e.g., one in each arm)
•while receiving ACEi, ARB, ARNi, and/or MRA,

•1\.Current acute decompensated HF. Subjects with a discharge from a hospitalization for acute decompensation of HF at least 4 weeks before
•Screening may be included
•2\. Symptomatic hypotension or systolic blood pressure \<90 mmHg
•3\. Significant primary aortic or mitral valvular heart disease (except mitral regurgitation due to left ventricular dilatation)
•4\. Heart transplantation or planned heart transplantation (i.e., currently on a heart transplant list) during the study period
•5\. Diagnosis of peripartum or chemotherapy\-induced cardiomyopathy or acute myocarditis in the previous 12 months
•6\. Implantation of a cardiac resynchronization therapy device in the previous 4 weeks
•7\. Restrictive, constrictive, hypertrophic, or obstructive cardiomyopathy
•8\. Untreated ventricular arrhythmia with syncope in the previous 4 weeks
•9\. History of, or current diagnosis of, a severe swallowing disorder, moderate\-to\-severe gastroparesis, or major gastrointestinal (GI)