The HeartCycle heart failure trials programme

Not Applicable

Completed

Conditions: Heart failure
Circulatory System

Registration Number: ISRCTN00926323

Lead Sponsor: Philips Research Laboratories (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 180

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

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