Strategies to Improve Prescribing in Heart Failure Patients

This study has suspended participant recruitment.
(Up to sponsor decision)
Sponsor:
Collaborators:
National Centre for Disease Prevention and Control
Associazione Nazionale Medici Cardiologi Ospedalieri
Information provided by (Responsible Party):
Niguarda Hospital
ClinicalTrials.gov Identifier:
NCT01023438
First received: November 30, 2009
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention
Chronic Heart Failure
Other: Strategy for assisted uptitration
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Niguarda Hospital:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • achievement of ≥ 50% of the target dose of both beta-blockers and ACE-inhibitors or angiotensin-receptor blockers [ Time Frame: 12 weeks ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
  • value of DRG reimbursement for hospital admissions and specialist visits [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 122
Study Start Date: January 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Assisted uptitration
Uptitration of recommended drugs by primary care physician with specialist support
Other: Strategy for assisted uptitration
Active specialist support (mail, phone) and educational material provided to assist primary care physicians in drug uptitration
Active Comparator: Usual care
Usual communication strategy from cardiologist to primary care physician
Other: Usual care
Usual communication strategy from cardiologist to primary care physician: uptitration advised but no active support nor educational material 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01023438

Locations
Italy
Azienda Opsedaliera Ospedale Niguarda Ca' Granda
Milano, MI, Italy, 20162
Sponsors and Collaborators
Niguarda Hospital
National Centre for Disease Prevention and Control
Associazione Nazionale Medici Cardiologi Ospedalieri
Investigators
Study Chair: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Niguarda Hospital
ClinicalTrials.gov Identifier: NCT01023438     History of Changes
Other Study ID Numbers: SMART SC
Study First Received: November 30, 2009
Last Updated: February 20, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014