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”

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

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

Intervention(s) in this Clinical Trial

• Other: Strategy for assisted uptitration
  • Active specialist support (mail, phone) and educational material provided to assist primary care physicians in drug uptitration
• Other: Usual care
  • Usual communication strategy from cardiologist to primary care physician: uptitration advised but no active support nor educational material provided

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Assisted uptitration
  • Uptitration of recommended drugs by primary care physician with specialist support
• Active Comparator: Usual care
  • Usual communication strategy from cardiologist to primary care physician

Primary Measures

• 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
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• achievement of ≥ 50% of the target dose of both beta-blockers and ACE-inhibitors or angiotensin-receptor blockers
  • Time Frame: 12 weeks
    Safety Issue?: No
• 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
  • Time Frame: 12 weeks
    Safety Issue?: No
• all cause death, hospital admissions, emergency room visits; changes in quality of life by SF12, a generic questionnaire
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• value of DRG reimbursement for hospital admissions and specialist visits
  • Time Frame: 12 weeks
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Niguarda Hospital Other

Overall Clinical Trial Officials and Contacts

Andrea Di Lenarda, MD Study Chair Cardiovascular Center ASS 1 Triestina, Trieste Italy  

Overall Contact: Renata De Maria, MD +39 02 66101344 renata_de_maria@hotmail.com

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01023438

Study ID Number: SMART SC

ClinicalTrials.gov Identifier: NCT01023438

Health Authority: Italy: Ethics Committee

official website of the Study Sponsor Italian Association of Hospital Cardiologists