This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Strategies to Improve Prescribing in Heart Failure Patients

This study has suspended participant recruitment.
(Up to sponsor decision)
National Centre for Disease Prevention and Control
Associazione Nazionale Medici Cardiologi Ospedalieri
Information provided by (Responsible Party):
Niguarda Hospital Identifier:
First received: November 30, 2009
Last updated: April 7, 2017
Last verified: April 2017
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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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 ]
  • 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 ]
  • all cause death, hospital admissions, emergency room visits; changes in quality of life by SF12, a generic questionnaire [ Time Frame: 12 weeks ]
  • value of DRG reimbursement for hospital admissions and specialist visits [ Time Frame: 12 weeks ]

Estimated Enrollment: 122
Actual Study Start Date: January 2010
Estimated Study Completion Date: December 2017
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01023438

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
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:
Responsible Party: Niguarda Hospital Identifier: NCT01023438     History of Changes
Other Study ID Numbers: SMART SC
Study First Received: November 30, 2009
Last Updated: April 7, 2017

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on September 21, 2017