Heart failure Circulatory System Heart failure
Conditions
Interventions
1. The study is conducted in three phases and the overall study experience constitutes a fourth
2. Patients who have had a recent hospitalisation for heart failure or who have heart failure but who ha
Sponsors
Philips Research Laboratories (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A clinical diagnosis of heart failure: 1.1. Cause of heart failure may be for any reason other than those that are rapidly reversible (see exclusion criteria) 1.2. May include patients with and without a low left ventricular ejection fraction or with valve disease 2. Requiring treatment with at least 40mg/day of furosemide or equivalent (1mg of bumetanide or 10mg of torasemide) 3. Evidence of advanced or unstable disease 4. Admission to hospital for or complicated by heart failure currently or within the previous 60 days. It is expected that most patients will be recruited by this criterion. 5.. Out-patients with persistent New York Heart Association (NYHA) III/IV symptoms 6. An elevated N-terminal pro-hormone of brain natriuretic peptide (NT-proBNP): 6.1. >1,000pg/ml if in sinus rhythm, including atrio-biventricular pacing 6.2. >2,000pg/ml if not in sinus rhythm
Exclusion criteria
Exclusion criteria: 1. Unwilling to comply with the protocol 2. Patients should be willing and able to make daily measurements at home throughout Protocol B 3. Rapidly reversible causes of heart failure such as severe anaemia (defined as the need for a blood transfusion), thyrotoxicosis, admission with rapid (>120bpm), atrial fibrillation with good ventricular function 4. Inability, in the investigators opinion, to operate or comply with the home telemonitoring system (HTM) system, even with available support from carers and health volunteers if available 5. Patients who are unable to communicate directly or indirectly in the local language (English in the UK, German in Germany and Spanish in Barcelona) cannot participate 6. People aged <18 years and vulnerable patient groups such as those with dementia, psychotic illness or educationally severely subnormal will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Protocol A: Observational Study of Therapy Optimisation. 1.1. Success will be measured as the proportion of patients reaching the target doses of each medication in their Care-Plan unless a specific contra-indication develops (such as bradycardia, hypotension, hyperkalaemia or renal dysfunction) to reaching target doses 1.2. The main aim of this part of the protocol is to provide a user-friendly tool that encourages and supports the health professional to optimise treatments that are known to alter prognosis 2. Protocol B ? Randomised, Open-label Diuretic Dose Minimisation and Optimisation: 2.1. Diuretic Minimisation Protocol: the primary outcome of this will be patient preference (see 7-point Likert scale which will be the evaluation tool in appendix) for down-titration or usual maintenance dose of diuretic. 2.2. Diuretic Optimisation Protocol: the primary outcome of this will be patient preference for up-titration rather than usual maintenance dose of diuretic. 3. Protocol C - Clinical Calibration Protocol: A Single (Investigator) -Blind Assessment Trial of Everyday Patient Events: Although ?interventions? occur at random, this study will be analysed principally as an observational study designed to assess the impact of the challenges of everyday life on monitored vital signs. 4. Protocol D Long-term Evaluation: This portion of the study focuses on the technical ability of the system to maintain the patients' vital monitoring signs within individually-tailored 'ideal' ranges and to gather information on medical events that were or were not predicted by the system | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed