Effect of moderate or intensive disease management program on outcome in patients with heart failure: Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH).

BACKGROUND: Heart failure (HF) disease management programs are widely implemented, but data about their effect on outcome have been inconsistent. METHODS: The Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH) was a multicenter, randomized, controlled trial in which 1023 patients were enrolled after hospitalization because of HF. Patients were assigned to 1 of 3 groups: a control group (follow-up by a cardiologist) and 2 intervention groups with additional basic or intensive support by a nurse specializing in management of patients with HF. Patients were studied for 18 months. Primary end points were time to death or rehospitalization because of HF and the number of days lost to death or hospitalization. RESULTS: Mean patient age was 71 years; 38% were women; and 50% of patients had mild HF and 50% had moderate to severe HF. During the study, 411 patients (40%) were readmitted because of HF or died from any cause: 42% in the control group, and 41% and 38% in the basic and intensive support groups, respectively (hazard ratio, 0.96 and 0.93, respectively; P = .73 and P = .52, respectively). The number of days lost to death or hospitalization was 39 960 in the control group, 33 731 days for the basic intervention group (P = .81), and 34 268 for the intensive support group (P = .49). All-cause mortality occurred in 29% of patients in the control group, and there was a trend toward lower mortality in the intervention groups combined (hazard ratio, 0.85; 95% confidence interval, 0.66-1.08; P = .18). There were slightly more hospitalizations in the 2 intervention groups (basic intervention group, P = .89; and intensive support group, P = .60). CONCLUSIONS: Neither moderate nor intensive disease management by a nurse specializing in management of patients with HF reduced the combined end points of death and hospitalization because of HF compared with standard follow-up. There was a nonsignificant, potentially relevant reduction in mortality, accompanied by a slight increase in the number of short hospitalizations in both intervention groups. Clinical Trial Registry http://trialregister.nl Identifier: NCT 98675639.

Anaemia and renal dysfunction are independently associated with BNP and NT-proBNP levels in patients with heart failure.

BACKGROUND: Anaemia may affect B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) levels, but this has not been well described in heart failure (HF) patients without the exclusion of patients with renal dysfunction. AIMS: To study the influence of both anaemia and renal function on BNP and NT-proBNP levels in a large group of hospitalised HF patients. METHODS AND RESULTS: We studied 541 patients hospitalised for HF (mean age 71+/-11 years, 62% male, and left ventricular ejection fraction 0.33+/-0.14). Of these patients, 30% (n=159) were anaemic (women: Hb<7.5 mmol/l, men: Hb<8.1 mmol/l). Of the 159 anaemic patients, 73% had renal dysfunction (eGFR<60 ml/min/1.73 m2) and of the non-anaemic patients, 57% had renal dysfunction. BNP and NT-proBNP levels were measured in all patients before discharge. In multivariable analyses both plasma haemoglobin and eGFR were independently related to the levels of BNP and NT-proBNP (standardised beta's of -0.16, -0.14 [BNP] and -0.19, -0.26 [NT-proBNP] respectively, P-values<0.01). CONCLUSION: Anaemia and renal dysfunction are related to increased BNP and NT-proBNP levels, independent of the severity of HF. These results indicate that both anaemia and renal dysfunction should be taken into consideration during the interpretation of BNP and NT-proBNP levels in HF patients.

Low prevalence of B-type natriuretic peptide levels < 100 pg/mL in patients with heart failure at hospital discharge.

BACKGROUND: In patients with acute heart failure (HF) presenting at the emergency department, a B-type natriuretic peptide (BNP) level < 100 pg/mL was found in only 10% of the patients. However, in a more stable outpatient HF population from another study, a BNP level < 100 pg/mL was found in as many as 21% of the patients. Therefore, we aimed to investigate the prevalence and characteristics of stabilized patients with BNP levels < 100 pg/mL before discharge after admission for decompensated heart failure HF. METHODS: We investigated 601 patients with HF who were part of a large-scale multicenter study in The Netherlands. All patients had been admitted for decompensated HF, and their BNP levels were measured before discharge when they had been clinically stabilized. Clinical characteristics of patients with BNP levels < 100 and > or = 100 pg/mL were compared. RESULTS: Patients were 70 +/- 12 years old, 61% were men, and mean left ventricular ejection fraction was 0.34 +/- 0.14. Of these patients, 10% had BNP levels < 100 pg/mL. Patients with a BNP level < 100 pg/mL were similar in age and sex but had higher left ventricular ejection fraction (0.41 +/- 0.14 vs 0.33 +/- 0.13, P < .001), body mass index, and hemoglobin and hematocrit concentrations compared with those with BNP levels > or = 100 pg/mL. CONCLUSIONS: In clinically stable patients with a recent admission for decompensated HF, only 10% had BNP levels > or = 100 pg/mL. These patients with low BNP levels seemed to have less severe HF and more frequently had preserved systolic function compared with patients with BNP levels > or = 100 pg/mL.

Correlates of B-type natriuretic peptide and 6-min walk in heart failure patients.

BACKGROUND: B-type natriuretic peptide (BNP) and 6-min walk test (6MWT) are both related to the severity and prognosis in chronic heart failure (CHF), but may reflect different aspects of CHF. We related BNP and 6MWT to left ventricular ejection fraction (LVEF), New York Heart Association functional class (NYHA), and two indices of quality of life (physical subscales): the Minnesota Living with Heart Failure Questionnaire (MLwHFQph) and the RAND-36ph. METHODS: Plasma BNP and 6MWT were measured at discharge in 229 patients who had been admitted for CHF. LVEF and NYHA were determined, and patients completed the MLwHFQ and RAND-36 questionnaires. RESULTS: BNP was weakly correlated to LVEF (r=-0.29, P<0.01) and NYHA (r=0.20, P<0.01), but not to MLwHFQph and RAND-36ph. On the other hand, 6MWT is related to MLwHFQph (r=-0.23, P<0.01), RAND-36ph (r=0.52, P<0.01), and NYHA (r=-0.46, P<0.01), but not to LVEF (r=-0.15, P=0.05). There is also no correlation between BNP and 6MWT (r=-0.01, P=0.87). CONCLUSIONS: The present data show that BNP and 6MWT represent different aspects of the clinical syndrome of CHF. The outcomes of this study suggest that BNP plasma levels are more related to cardiac function, while 6MWT reflects functional capacity and quality of life.

Influence of age on natriuretic peptides in patients with chronic heart failure: a comparison between ANP/NT-ANP and BNP/NT-proBNP.

BACKGROUND: Natriuretic peptides are currently used in the diagnosis and follow-up of patients with Chronic Heart Failure (CHF). However, it is unknown whether there are different influences of age on atrial natriuretic peptide (ANP)/N-terminal-ANP (NT-ANP) or B-type natriuretic peptide (BNP)/N-terminal-proBNP (NT-proBNP). AIMS: To compare the influence of age and gender on plasma levels of ANP/NT-ANP and BNP/NT-proBNP in CHF patients. METHODS AND RESULTS: Natriuretic peptides were measured in 311 CHF patients (68+/-8 years, 76% males, left ventricular ejection fraction (LVEF) 0.23+/-0.08). All natriuretic peptides were significantly related to age (p<0.05) on multivariate regression analysis, with partial correlation coefficients of 0.18, 0.29, 0.28 and 0.25 for ANP, NT-ANP, BNP and NT-proBNP, respectively. The relative increase of both BNP/NT-proBNP were more pronounced than of ANP/NT-ANP (p<0.01). Furthermore, the relative increase of BNP with age was markedly larger than of NT-proBNP (p<0.01). Levels of all natriuretic peptides were also significantly related to cardiothoracic ratio, renal function and LVEF. CONCLUSION: In patients with CHF, BNP/NT-proBNP were more related to age than ANP/NT-ANP, and BNP was more related to age than NT-proBNP. However, in these CHF patients the influence of age on the levels of all natriuretic peptides was modest, and comparable to several other factors.

Design and methodology of the COACH study: a multicenter randomised Coordinating study evaluating Outcomes of Advising and Counselling in Heart failure.

BACKGROUND: While there are data to support the use of comprehensive non-pharmacological intervention programs in patients with heart failure (HF), other studies have not confirmed these positive findings. Substantial differences in the type and intensity of disease management programs make it impossible to draw definitive conclusions about the effectiveness, optimal timing and frequency of interventions. AIMS: 1. To determine the effectiveness of two interventions (basic support vs. intensive support) compared to 'care as usual' in HF patients, on time to first major event (HF readmission or death), quality of life and costs. 2. To investigate the role of underlying mechanisms (knowledge, beliefs, self-care behaviour, compliance) on the effectiveness of the two interventions. METHODS: This is a randomised controlled trial in which 1050 patients with heart failure will be randomised into three treatment arms: care as usual, basic education and support or intensive education and support. Outcomes of this study are; time to first major event (HF hospitalisation or death), quality of life (Minnesota Living with HF Questionnaire, RAND36 and Ladder of Life) and costs. Data will be collected during initial admission and then 1, 6, 12, and 18 months after discharge. In addition, data on knowledge, beliefs, self-care behaviour and compliance will be collected. RESULTS: The study started in January 2002 and results are expected at the end of 2005. CONCLUSIONS: This study will help health care providers in future to make rational and informed choices about which components of a HF management program should be expanded and which components can possibly be deleted.