Strategies to Improve Prescribing in Heart Failure Patients

Condition(s) targeted: Chronic Heart Failure

Intervention: Strategy for assisted uptitration (Other); Usual care (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Niguarda Hospital

Official(s) and/or principal investigator(s):
Andrea Di Lenarda, MD, Study Chair, Affiliation: Cardiovascular Center ASS 1 Triestina, Trieste Italy
Fabrizio Oliva, MD, Study Chair, Affiliation: Heart Failure Heart Transplant Program, Cardiovascular Department, Niguarda Hospital, Milan, Italy

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

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

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: 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

Secondary outcome:

achievement of ≥ 50% of the target dose of both beta-blockers and ACE-inhibitors or angiotensin-receptor blockers

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

all cause death, hospital admissions, emergency room visits; changes in quality of life by SF12, a generic questionnaire

value of DRG reimbursement for hospital admissions and specialist visits

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Renata De Maria, MD, Phone: +39 02 66101344, Email: renata_de_maria@hotmail.com

Azienda Opsedaliera Ospedale Niguarda Ca' Granda, Milano, MI 20162, Italy; Recruiting
Fabrizio Oliva, MD, Phone: +39 02 6444 2563, Email: fabrizio.oliva@ospedaleniguarda.it
Fabrizio Oliva, MD, Principal Investigator

official website of the Study Sponsor Italian Association of Hospital Cardiologists

Starting date: January 2010
Last updated: July 21, 2011