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INTEgRated Health CARE for Patients With Frailty and Heart Failure

RecruitingNAAges 18 Years - anyAllVestre Viken Hospital Trust
NCT06444321 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Frailty, an aging-related syndrome of physiological decline characterized by marked vulnerability to adverse health outcomes, has attracted increasing attention in cardiology due to the growing elderly population with heart failure. Frail patients are mainly excluded from large cardiovascular intervention studies, and clinical trials addressing frailty and showing an impact on treatment on symptom burden, quality of life and /or outcome has been requested in recent guidelines and consensus documents. The INTEgrRated health CARE for patients with severe frailty and Heart Failure (INTERCARE-HF) is a proof-of-concept study that aims to evaluate the effect of integrated healthcare services for heart failure patients with a severe level of frailty by establishing interdisciplinary and coordinated follow-up teams across the healthcare boundaries. These teams will assess the patient's needs, go

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age \>18 years old * Admitted to hospital with heart failure with symptoms of decompensation including dyspnoea in NYHA class ≥ II, pulmonary congestion on chest x-ray and/or other signs like oedema or positive rales on auscultation and elevated NT-proBNP concentrations at screening * Clinical Frailty Score ≥5 * Signed informed consent by patient and closest relatives\* and expected cooperation according to the protocol, ICH/GCP and national/local regulations * Although we preferably will recruit both patients and their relatives, participation from the next-of-kin will not be an exclusion criterium. Exclusion Criteria: * Inability to comply with all study requirements, due to major co-morbidities or psychosocial issues, or a history of noncompliance, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures. * Not being able to understand Norwegian. * Permanent nursing home and estimated to stay alive for less than 6 months
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What it tests

  • INTERCARE-HF
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Where

1 site
Drammen Hospital
Drammen, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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