A randomised study of a Nurse-led Intervention for Less Chronic Heart Failure: The NIL-CHF Study

A randomised study of a Nurse-led Intervention in patients with cardiovascular disease states who are at high risk of developing heart failure comparing all-cause mortality during 5-year follow-up.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000022369

Acronym

The NIL-CHF Study

Enrollment

624

Registered

2008-01-16

Start date

2008-06-12

Completion date

2010-07-12

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The primary aim of this study is to develop a cost-effective health care program to prevent the development of Chronic Heart Failure (CHF). This unique and innovative study will examine the impact of a specialist nurse-led, multidisciplinary, home and clinic-based intervention for patients at high risk of developing CHF relative to usual post-discharge and community care. It will target patients aged > 50 years discharged from hospital with a broad range of cardiovascular disease states (including diabetes) in order to optimise their cardiovascular health. An appropriately powered randomised study will compare the composite primary end-point of incident CHF-related admission or all-cause mortality during 5-year follow-up.

Interventions

Specialist nurse-led multi-disciplinary, home and clinic based intervention involving comprehensive clinical assessment with application of gold-standard pharmacologic and non-pharmacologic therapy, promotion of self-care behaviours and enhanced surveillance & facilitated access to cardiac nurse in order to maximise patients' cardiac, renal and neurological function. The intervention follow-up period for participants will be 3.5 years in total.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

All elective and emergency patients admitted to the Alfred Hospital, Melbourne. Eligible for study if (i) discharged to home (ii) have a diagnosis of one of the common forms of cardiovascular disease or being actively treated for either of the 2 most common heart failure antecedents other than coronary heart disease (eg diabetes, metabolic syndrome or hypertension)

Exclusion criteria

Diagnosed with congenital condition, have surgically repairable or significant valvular disease, have a terminal malignancy, live beyond a 45km radius from the hospital or have an acute coronary event (eg acute myocardial infarction) within previous 30 days. Further exclusion of those randomised subjects who experience a HF-related hospitalisation prior to the 30-35 day advanced clinical assessment.

Outcome results