Heart failure arises when the heart’s ability to pump blood around the body is impaired. This deprives the body’s tissues of the oxygen and nutrients upon which their survival depends. It commonly occurs as a result of conditions such as ischaemic heart disease, diabetes and high blood pressure.
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Heart failure may be classified as being either acute or chronic. Acute heart failure is characterised by a sudden onset of symptoms, whereas in chronic heart failure typically develops and worsens over time.
Examples of the symptoms associated with heart failure include dyspnoea, fatigue, difficulty exercising, and oedema, particularly peripheral oedema. Symptoms may vary depending on which side or sides of the heart are affected.
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The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a Paediatric Use Marketing Authorisation (PUMA) for the medicinal product Aqumeldi, intended for the treatment of heart failure in children from birth to less than 18 years.
BioCardia, Inc. announced it has finalized external review of interim data and evaluated interim efficacy results for the ongoing Phase III pivotal trial of CardiAMP Cell Therapy for Heart Failure (CardiAMP HF, clinicaltrials.gov Identifier: NCT02438306), for which the FDA granted Breakthrough Designation for the treatment of heart failure of reduced ejection fraction (HFrEF)