Darren A. DeWalt, MD, MPH
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?
Randomized controlled trial (RCT) (NorthStar). Centerwatch.com 173491.
Blinded† (vital status and hospitalization assessors).
Median 2.5 years.
18 public HF clinics in Denmark.
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.
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.
A composite of all-cause mortality or CV hospitalization. Secondary outcomes included individual components of the composite outcome.
100% (intention-to-treat analysis).
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).
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‡
‡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.
DeWalt DA. Extended follow-up in an HF clinic did not reduce death or hospital admission in stable systolic HF. Ann Intern Med. ;157:JC6–9. doi: 10.7326/0003-4819-157-12-201212180-02009
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Published: Ann Intern Med. 2012;157(12):JC6-9.
Cardiology, Heart Failure, Hospital Medicine.
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