Document Detail


Extended follow-up in an HF clinic did not reduce death or hospital admission in stable systolic HF.
MedLine Citation:
PMID:  23247958     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
QUESTION In adults with stable systolic heart failure (HF) treated with optimal medical therapy, does extended follow-up in an HF clinic reduce death or cardiovascular (CV) hospitalizations? METHODS DESIGN Randomized controlled trial (RCT) (NorthStar). Centerwatch.com 173491. ALLOCATION {Concealed}*.† BLINDING Blinded† (vital status and hospitalization assessors). FOLLOW-UP PERIOD Median 2.5 years. SETTING 18 public HF clinics in Denmark. PATIENTS 921 adults ≥ 18 years of age (mean age 69 y, 75% men) who had clinically stable systolic HF with left ventricular ejection fraction ≤ 45% and were educated in HF and self-management. Unless contraindicated, they were treated with angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin II-receptor blockers (ARBs), β-blockers (BBs) at recommended or maximum tolerated doses, aldosterone-receptor antagonists (ARAs), and implantable cardiac defibrillators and/or cardiac resynchronization therapy if indicated. Exclusion criteria included plasma creatinine levels > 200 µmol/L; waiting for a heart transplant; valvular or ischemic heart disease with planned surgery or percutaneous intervention; cancer with life expectancy < 5 years; dementia; or withdrawal of ACEIs/ARBs, BBs, or ARAs due to a reversible cause of cardiomyopathy. INTERVENTION Extended follow-up in HF clinics (n = 461) or usual care with general practitioners (GPs) (n = 460). Extended follow-up included visits at 1- to 3-month intervals, with repeated education if adherence to medical treatment was reduced; monitoring symptoms, weight, blood pressure, and electrolytes; adjusting diuretics if HF progressed; managing comorbid conditions; and access to free daily telephone consultations with a cardiologist-supervised HF nurse. OUTCOMES A composite of all-cause mortality or CV hospitalization. Secondary outcomes included individual components of the composite outcome. PATIENT FOLLOW-UP 100% (intention-to-treat analysis). MAIN RESULTS Groups did not differ for the primary composite outcome or its individual components (Table). In planned subgroup comparisons, the primary outcome did not differ by amino-terminal-pro-brain-natriuretic-peptide (NT-proBNP) level (P = 0.72 for interaction) (Table). CONCLUSION In adults with stable systolic heart failure treated with optimal medical therapy, extended follow-up in a heart failure clinic did not reduce death or cardiovascular hospitalizations.Extended follow-up in a heart failure (HF) clinic vs usual care in stable systolic HF treated with optimal medical therapy‡OutcomesSubgroupHF clinicUsual careAt a median 2.5 yRRI (95% CI)NNHPrimary outcome§All38%35%13% (-4 to 33)NSNT-proBNP ≥ 1000 pg/mL41%38%8% (-16 to 35)NSNT-proBNP < 1000 pg/mL36%32%17% (-8 to 46)NSMortalityAll13%14%4.6% (-25 to 45)||NSCV hospitalizationAll31%27%15% (-6 to 39)NS‡CV = cardiovascular; NS = not significant; NT-proBNP = amino-terminal-pro-brain-natriuretic-peptide; other abbreviations defined in Glossary. RRI, NNH, and CI calculated from control event rates and hazard ratios in article.§All-cause mortality or CV hospitalization.||Although fewer patients died in the HF clinic group than in the usual care group, differences in follow-up time result in an RRI, rather than an RRR, for mortality.
Authors:
Darren A Dewalt
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Annals of internal medicine     Volume:  157     ISSN:  1539-3704     ISO Abbreviation:  Ann. Intern. Med.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372351     Medline TA:  Ann Intern Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  JC6-9     Citation Subset:  AIM; IM    
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