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:
“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).
For more information, please visit viforpharma.com.
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.
References:
1 Desai AS, et al. J Am Coll Cardiol 2007;50:1959–66.
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