Use of Physiological Techniques in Heart Failure Management

Category Primary study
Registry of TrialsANZCTR
Year 2009
INTERVENTION: 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 CONDITION: Heart failure PRIMARY OUTCOME: The primary (composite) end‐point of this study is event‐free survival from death or unplanned readmission assessed from patient medical notes SECONDARY OUTCOME: each component of the composite endpoint: ; a. all‐cause mortality ; b. Congestive heart failure related non‐fatal hospital admissions ; c. Congestive heart failure fatal events ; ‐ assessed from hospital medical records functional status assessed by oxygen and exercise stress testing, 6 minute walk test and questionnaires Quality of Life assessed by questionnaires The secondary endpoint will be improvement of Left Ventricular (LV) volumes and functional capacity in the monitored group as assessed by echocardiography, VO2 (oxygen uptake during exercise) testing exercise stress testing, 6 minute walk test, self care and knowledge questionnaires use of appropriate medical therapy for comorbidity assessed by physician monitoring INCLUSION CRITERIA: Age >=40 years Diagnosis of Heart Failure Not suitable for cardiac resynchronisation therapy Not suitable for revascularisation
Epistemonikos ID: b6a7dc4109f894aad354e0970fa1c9a31c4624b6
First added on: Aug 22, 2024