Clinical trial NCT01023438: Strategies to Improve Prescribing in Heart Failure Patients
Official title: Strategies To Improve Appropriate Prescribing In Heart Failure Patients. Assessment of the Effectiveness of an Integrated Clinical Pathway Between Cardiology and Primary Care Physicians to Implement Pharmacological Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Heart Failure
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
Collaborators: name: National Centre for Disease Prevention and Control
name: Associazione Nazionale Medici Cardiologi Ospedalieri
First posted: 2009-12-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 12 weeks
Secondary outcomes:
measure: achievement of ≥ 50% of the target dose of both beta-blockers and ACE-inhibitors or angiotensin-receptor blockers
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: all cause death, hospital admissions, emergency room visits; changes in quality of life by SF12, a generic questionnaire
timeFrame: 12 weeks
measure: value of DRG reimbursement for hospital admissions and specialist visits
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Azienda Opsedaliera Ospedale Niguarda Ca' Granda
state: MI
Study officials:
affiliation: Cardiovascular Center ASS 1 Triestina, Trieste Italy
name: Andrea Di Lenarda, MD
role: STUDY_CHAIR
affiliation: Heart Failure Heart Transplant Program, Cardiovascular Department, Niguarda Hospital, Milan, Italy
name: Fabrizio Oliva, MD
role: STUDY_CHAIR
References: