Chronic Heart Failure
Conditions
Brief summary
The purpose of the study is to assess whether primary care physicians may uptitrate recommended drug therapies in stable heart failure patients if educational material and specialist support including phone or mail consultation are provided
Detailed description
Heart failure is highly prevalent, particularly in elderly subjects, and costly, mainly because of the high rate of recurrent hospital admissions. Although guideline-recommended treatments, such as beta-blockers and renin-angiotensin inhibitors, are effective on both mortality and morbidity, these drugs are very often underprescribed or used at lower doses than those shown to be beneficial in clinical trials, particularly in the primary care setting, for fear of adverse events. Although referral to specialist services may improve prescription of recommended drugs and doses achieved, frequent consultations may be unfeasible and costly.The study is designed to assess whether active specialist support and educational material improve the prescription process for heart failure patients in primary care
Interventions
OTHERStrategy for assisted uptitration
Active specialist support (mail, phone) and educational material provided to assist primary care physicians in drug uptitration
OTHERUsual care
Usual communication strategy from cardiologist to primary care physician: uptitration advised but no active support nor educational material provided
Sponsors
National Centre for Disease Prevention and Control
Associazione Nazionale Medici Cardiologi Ospedalieri
Niguarda Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* a confirmed diagnosis of heart failure wih depressed systolic function (left ventricular ejection fraction \<40% in the previous 6 months). * stable NYHA class II-III * a clinical indication to implement drug therapy with betablockers and/or renin-angiotensin system inhibitors and current dose \<50% of the target dose
Exclusion criteria
* NYHA class IV or clinically unstable * cardiac surgery or cardiac resynchronization therapy planned within the following 6 months * discharged to a rehabilitation unit refusal or impossibility to present to outpatient visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| achievement of ≥ 50% of the target dose either for beta-blockers (12.5mg b.i.d. for carvedilol, 5mg u.i.d for bisoprolol) or for ACE-inhibitors or angiotensin-receptor blockers in patients in whom beta-blockers are contraindicated | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| achievement of ≥ 50% of the target dose of both beta-blockers and ACE-inhibitors or angiotensin-receptor blockers | 12 weeks |
| proportion of patients who started drug uptitration by week 12 expressed as N° patients in whom therapy was uptitrated by their primary care physician/N° randomized patients | 12 weeks |
| all cause death, hospital admissions, emergency room visits; changes in quality of life by SF12, a generic questionnaire | 12 weeks |
| value of DRG reimbursement for hospital admissions and specialist visits | 12 weeks |
Countries
Italy
Outcome results
None listed