Strategies to Improve Prescribing in Heart Failure Patients

NCT01023438 | Terminated

• 1 other identifier: SMART SC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Assisted uptitration

EXPERIMENTAL

Uptitration of recommended drugs by primary care physician with specialist support

Other: Strategy for assisted uptitration

Usual care

ACTIVE COMPARATOR

Usual communication strategy from cardiologist to primary care physician

Other: Usual care

Interventions

Strategy for assisted uptitration OTHER

Active specialist support (mail, phone) and educational material provided to assist primary care physicians in drug uptitration

Assisted uptitration

Usual care OTHER

Usual communication strategy from cardiologist to primary care physician: uptitration advised but no active support nor educational material provided

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Niguarda Hospital: lead
• National Centre for Disease Prevention and Control: collaborator
• Associazione Nazionale Medici Cardiologi Ospedalieri: collaborator

Study Sites (1)

Azienda Opsedaliera Ospedale Niguarda Ca' Granda

Milan, MI, 20162, Italy

Location

Related Links

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

Study Officials

• Andrea Di Lenarda, MD

  Cardiovascular Center ASS 1 Triestina, Trieste Italy

  STUDY CHAIR

• Fabrizio Oliva, MD

  Heart Failure Heart Transplant Program, Cardiovascular Department, Niguarda Hospital, Milan, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: January 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2017
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

IT (1)