Strategies to Improve Prescribing in Heart Failure Patients

Chronic Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01023438
• Other study ID #: SMART SC
• Status: Terminated
• Phase: N/A
• Start date: January 2010
• Est. completion date: April 2017

Study information

• Verified date: June 2018
• Source: Niguarda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: April 2017
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda Opsedaliera Ospedale Niguarda Ca' Granda	Milano	MI

Sponsors (3)

Lead Sponsor	Collaborator
Niguarda Hospital	Associazione Nazionale Medici Cardiologi Ospedalieri, National Centre for Disease Prevention and Control

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	achievement of = 50% of the target dose of both beta-blockers and ACE-inhibitors or angiotensin-receptor blockers		12 weeks
Secondary	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
Secondary	all cause death, hospital admissions, emergency room visits; changes in quality of life by SF12, a generic questionnaire		12 weeks
Secondary	value of DRG reimbursement for hospital admissions and specialist visits		12 weeks

External Links

•   official website of the Study Sponsor Italian Association of Hospital Cardiologists