Thursday, April 29, 2021

First patient enrolled in CARE-HK in HF to evaluate role of Veltassa® (patiromer) in enabling RAASi treatment

 ST. GALLEN, Switzerland -Wednesday 28 April 2021 [ AETOS Wire ]

  • CARE-HK in heart failure (HF) is the first global registry of around 5,000 patients with chronic HF who have or are at high risk for hyperkalemia (HK), in Europe and the US
  • CARE-HK in HF is designed to evaluate the use of Veltassa® in enabling patients to remain on RAASi therapy in HF patients with or at high risk for HK
  • Topline results are anticipated in 2024

(BUSINESS WIRE)-- Regulatory News:

Vifor Pharma today announced that the first patient has been enrolled in the large scale registry CARE-HK in HF (cardiovascular and renal treatment in HF patients with or at high risk for HK). This non-interventional clinical study aims to better understand renin-angiotensin-aldosterone system inhibitors (RAASi) treatment decisions in clinical practice, potential barriers to achieving optimal guideline-directed care in HF patients with or at high risk for HK, and to assess how Veltassa® may be used in the management of this patient population.

“One of the most pressing issues in management of chronic heart failure is that therapies that have proven to reduce the risk of death and hospitalizations, and are thus strongly recommended by the guidelines, are not optimally used in clinical practice. This is certainly the case with RAASi, which are under-used in many patients, especially those with or at high risk of hyperkalemia,” said Dr. Mikhail Kosiborod, cardiologist at Saint Luke’s Mid America Heart Institute, Vice President of Research at Saint Luke’s Health System and Professor of Medicine at University of Missouri-Kansas City. “CARE-HK in HF will investigate the patterns of RAASi use, and barriers to treatment optimization, and examine whether adherence to guidelines is associated with improved real-world outcomes. This data from a large, international, prospective registry – the first of its kind to focus on this vulnerable patient group – will be very useful in future efforts to optimize the quality of care.”

Dr. Stefan Anker, Professor at Charité Universitätsmedizin, Berlin, Germany, added: “Hyperkalemia is frequent in HF patients and when a patient experienced it for the first time, there is a high likelihood to experience it again. Hyperkalemia is too rarely managed effectively. Taking care of hyperkalemia chronically may be the key to increase our ability to treat more patients with guideline recommended therapies such as RAASi and MRAs to meet the therapeutic goals. By learning from the CARE-HK in HF registry about the RAASi treatment patterns and the management of hyperkalemia, we may improve the current clinical practice for our HF patients with or at high risk of HK.”

Dr. Klaus Henning Jensen, Chief Medical Officer Vifor Pharma commented: “I am very pleased about the enrollment of the first patient in the CARE-HK in HF registry, which to date is the most important commitment in real-world evidence to evaluate RAASi therapy in combination with the use of Veltassa®. CARE-HK in HF will help the medical community to better understand the potential value of Veltassa® in treating hyperkalemia. We are looking forward to quickly ramping up enrollment to meet interest from participating hospitals and physicians.”

About CARE-HK in HF
This non-interventional, international, multi-center registry includes approximately 5,000 patients in 11 countries and 185 sites in Europe and the US. As a primary objective, CARE-HK in HF sets out to describe RAASi treatment patterns, specifically in the context of HK management, and to evaluate the potential role of Veltassa® in HF patients using RAASi therapy in clinical practice by comparing patients treated and not treated with Veltassa®. Patients with chronic heart failure diagnosed at least three months prior to enrollment and with or at greater risk of HK are eligible. They will be receiving renin-angiotensin-aldosterone system inhibitors and either receiving, or be candidates for, mineralocorticoid receptor antagonist (MRA) treatment per a relevant treatment guideline. Data will be collected two years retrospectively or from the onset of HF, and each patient will follow routine clinical care prospectively for two to four years. First results on the baseline data and retrospective analyses are expected in 2022, with topline results anticipated for 2024.

About Vifor Pharma Group
Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

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About Veltassa®
Veltassa® is a sodium-free potassium binder approved for the treatment of hyperkalaemia. Veltassa® should not replace emergency treatment for life-threatening hyperkalaemia. Made in powder form consisting of smooth, spherical beads, Veltassa® is mixed with water and taken once a day with food. Veltassa® is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.

About hyperkalemia
HK can cause life-threatening abnormal heart rhythm and even sudden death1. There are often no warning symptoms, meaning patients can unknowingly experience recurring spikes in potassium levels and be at risk of cardiac events.


1 Desai AS, et al. J Am Coll Cardiol 2007;50:1959–66.

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