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Home monitoring with integrated risk-stratified disease management support versus home monitoring alone in patients with heart failure

Home monitoring with integrated risk-stratified disease management support versus home monitoring alone in patients with heart failure: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN86212709
Enrollment
200
Registered
2014-09-05
Start date
2014-09-01
Completion date
Unknown
Last updated
2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cardiovascular disease

Interventions

Intervention: Collection of symptoms, physiological and system usage information from commercially available home monitoring devices and their integration with electronic health records (EHRs) for est

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the trial 2. Male or female, aged 18 years or above 3. Diagnosed with heart failure, defined as presence of typical symptoms (e.g. breathlessness, ankle swelling, and fatigue) and signs (e.g. elevated jugular venous pressure, pulmonary crackles, and displaced apex beat) resulting from an abnormality of cardiac structure or function 4. Potential to benefit from home monitoring and management defined as: 4.1. Self-assessed NYHA class II to IV; or 4.2. BNP >100 pg/L or NT-pro-BNP >360 pg/L in the last 30 days (excluding in-hospital measures) AND either 4.3. Not on optimal therapy (in view of the Investigator), or 4.4. Probability of death within one year >10% (MAGGIC integer score 20 or more) 4.5. At least one hospital admission related to heart failure in the previous 12 months

Exclusion criteria

Exclusion criteria: 1. No reliable 3G mobile or Wi-Fi network connectivity at home 2. Unable to read or speak English 3. Any other significant disease, including critical unstable or end-stage heart failure, which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant?s ability to participate in the trial

Design outcomes

Primary

MeasureTime frame
Optimal medical therapy is defined as treatment consistent with the NICE guidelines for management of patients with chronic heart failure and will be measured as a composite opportunity score

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026