None listed
Conditions
Brief summary
The aim of this study is to determine whether sequential physiologic assessment using B-type Natriuretic Peptile (BNP), 3-dimensional and strain rate echocardiography can guide the management of Congestive Heart Failure. The efficacy of this strategy will be established by assessment of functional capacity using measurement of oxygen uptake with exercise (VO2), 6-minute walk (6MW), hospital admissions and quality of life. The study will also assess whether a the use of a combination of nitrate (isosorbide mononitrate) and hydralazine in addition to the contemporary medical regimen (including beta blockers and ACE Inhibitors) leads to improved outcomes in symptomatic patients with systolic heart failure. Hypotheses: #1 – Short-term (3 month) reduction of end-systolic volume on medical therapy, BNP and cardiac imaging are predictors of improved functional capacity, BNP and Quality Of Life (QOL) at 12 months. This will be addressed by an observational trial. #2 - Use of physiologic testing to guide intensity of a Heart Failure Managment Program (HFMP) (including the combination of isosorbide mononitrate and hydralazine to the contemporary medical regimen) leads to better outcomes over 2 years follow-up.
Interventions
Lifestyle intervention: intensive heart failure education over 12 weeks by study nurses to encourage a life-time low salt diet, fluid monitoring and regular daily exercise as tolerated, as well as awareness of symptoms of exacerbation of heart failure and knowledge of disease process. Two weekly phone calls for 2 years after randomisation by study nurse to monitor health status and provide encouragement. Titration of medications by a cardiologist at monthly visits, guided by echocardiography.
Lifestyle intervention: intensive heart failure education over 12 weeks by study nurses to encourage a life-time low salt diet, fluid monitoring and regular daily exercise as tolerated, as well as awareness of symptoms of exacerbation of heart failure and knowledge of disease process. Two weekly phone calls for 2 years after randomisation by study nurse to monitor health status and provide encouragement. Titration of medications by a cardiologist at monthly visits, guided by echocardiography. Functional status as measured by oxygen uptake and exercise stress test and 6 minute walk test prior to randomisation and at one and two years, blood testing to monitor renal & liver function and B-type natriuretic peptile (BNP) level during titration of medication, at randomisation and at one and two years
Sponsors
National Health and Medical Research Council
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age >=40 years Diagnosis of Heart Failure Not suitable for cardiac resynchronisation therapy Not suitable for revascularisation
Exclusion criteria
Suitable for revascularisation Suitable for cardiac resynchronisation therapy No diagnosis of heart failure
Outcome results
None listed