Strategies to Improve Prescribing in Heart Failure Patients

Not Applicable

Terminated

• Conditions: Chronic Heart Failure
• Interventions: Other: Usual care; Other: Strategy for assisted uptitration

• Registration Number: NCT01023438
• Lead Sponsor: Niguarda Hospital

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

Study Timeline

• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Study Start: 2010-01
• Primary Completion: 2010-04
• Study Completion: 2017-04
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	Usual communication strategy from cardiologist to primary care physician
Assisted uptitration	Strategy for assisted uptitration	Uptitration of recommended drugs by primary care physician with specialist support

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Azienda Opsedaliera Ospedale Niguarda Ca' Granda; 🇮🇹 Milano, MI, Italy