None listed
Conditions
Brief summary
450 eligible patients admitted with ADHF will be enrolled and randomised to NP-guided or clinically-guided care. Baseline tests including NP levels will be measured at admission and then repeated on the day of discharge. Day of discharge will be determined by the attending physician and care will be transferred to the research team at point of discharge. Pre-discharge NP levels will only be available for patients randomised to the NP group. Off-label measurement of NP levels outside of guidelines approved indications, will be discouraged and prohibited by study design in both study groups. Patients randomised to usual care will be managed according to usual ADHF care. Patients in the BNP group will receive management guided by NP levels Management: Usual care group – patients will receive usual care for ADHF including in-hospital education about HF, weight self-monitoring, low salt diet, an exercise program, review in primary care and HF clinic within 2 weeks of discharge, coordinated input from district nursing and allied health at discretion of attending physician to ensure adequate support and housing, optimisation of medications according to HF guidelines. Further clinic follow-up will be guided by assessment at the 2-week visit. NP group - As for usual care but for patients with NTproBNP >1000pg/ml prior to discharge, delay of discharge for 24hrs will be considered to optimise diuretic and other HF therapy. After discharge, NP levels will be measured during HF nurse review at home within 2 days of discharge. Patients with NT-proBNP >1000pg/ml will receive alternate day telephone contact, weekly in-home HF nurse clinical review and 2-weekly HF clinic visits until NTproBNP <1000pg/ml. NTproBNP / estimated glomerular filtration rate (eGFR) testing will be performed at least weekly to guide up-titration of HF treatment – including increased diuretic dose if congestion or volume overload present, addition of spironolactone, alternate up-titration of ACE inhibitor and beta-blocker doses on a weekly basis.
Interventions
450 eligible patients admitted with Acute Decompensated Heart Failure (ADHF) will be enrolled and randomised to Natruiretic Peptide (NP)-guided group with treatment adjusted if NP levels are raised, or standard clinically-guided care. Baseline tests including NP levels will be measured by a blood tests at admission and then repeated on the day of discharge. Day of discharge will be determined by the attending physician and care will be transferred to the research team at point of discharge for t
450 eligible patients admitted with Acute Decompensated Heart Failure (ADHF) will be enrolled and randomised to Natruiretic Peptide (NP)-guided group with treatment adjusted if NP levels are raised, or standard clinically-guided care. Baseline tests including NP levels will be measured by a blood tests at admission and then repeated on the day of discharge. Day of discharge will be determined by the attending physician and care will be transferred to the research team at point of discharge for the NP group to manage follow up visits. Pre-discharge NP levels will only be available for patients randomised to the NP group. Off-label measurement of NP levels outside of guidelines approved indications, will be discouraged and prohibited by study design in both study groups. Patients randomised to usual care will be managed according to usual ADHF care. Patients in the NP group will receive management guided by NP levels. All study participants will be monitored for treatment adherence by phone or in person visits at 2 days, 2, 6 & 12 weeks and additional visits will be arranged as required. NP group - As for usual care but for patients with NTproBNP >1000pg/ml prior to discharge, delay of discharge for 24hrs will be considered to optimise diuretic and other HF therapy. After discharge, NP levels will be measured during HF nurse review at home within 2 days of discharge. Patients with NT-proBNP >1000pg/ml will receive alternate day telephone contact, weekly in-home HF nurse clinical review and 2-weekly HF clinic visits until NTproBNP <1000pg/ml. NTproBNP / estimated glomerular filtration rate (eGFR) testing will be performed at least weekly to guide up-titration of HF treatment – including increased diuretic dose if congestion or volume overload present, addition of spironolactone, alternate up-titration of ACE inhibitor and beta-blocker doses on a weekly basis. The overall duration of the intervention period is 12 weeks. Patients screened but not randomised to a treatment group will be included in a registry. Patients recorded in the registry but not randomised to a treatment arm will have no further interaction with the research team and care will continue as determined by their clinical team. Outcome data will be collected for registry patients to allow comparison with the study cohort.
Sponsors
Christchurch Heart Institute. University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients aged >18 year, living independently and able to provide informed consent, admitted with ADHF as evidenced by typical clinical features plus either radiological evidence of Heart Failure or an NTproBNP level >1000pg/ml.
Exclusion criteria
A primary diagnosis of acute coronary syndrome (ACS), myocarditis/pericarditis, pericardial constriction, a life expectancy due to non-cardiac disease of <6 months, concurrent severe hepatic or pulmonary disease ,severe renal impairment (plasma creatinine >250 micro mol/L), severe valvular disease requiring surgery, severe aortic stenosis (valve area <1cm^2), or HF due to mitral stenosis, or a patient under consideration for cardiac transplantation
Outcome results
None listed