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Strategies to Improve Prescribing in Heart Failure Patients

Primary Purpose

Chronic Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Strategy for assisted uptitration
Usual care
Sponsored by
Niguarda Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Azienda Opsedaliera Ospedale Niguarda Ca' Granda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Assisted uptitration

Usual care

Arm Description

Uptitration of recommended drugs by primary care physician with specialist support

Usual communication strategy from cardiologist to primary care physician

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
November 30, 2009
Last Updated
June 26, 2018
Sponsor
Niguarda Hospital
Collaborators
National Centre for Disease Prevention and Control, Associazione Nazionale Medici Cardiologi Ospedalieri
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1. Study Identification

Unique Protocol Identification Number
NCT01023438
Brief Title
Strategies to Improve Prescribing in Heart Failure Patients
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 Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Up to sponsor decision
Study Start Date
January 2010 (Actual)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Niguarda Hospital
Collaborators
National Centre for Disease Prevention and Control, Associazione Nazionale Medici Cardiologi Ospedalieri

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assisted uptitration
Arm Type
Experimental
Arm Description
Uptitration of recommended drugs by primary care physician with specialist support
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual communication strategy from cardiologist to primary care physician
Intervention Type
Other
Intervention Name(s)
Strategy for assisted uptitration
Intervention Description
Active specialist support (mail, phone) and educational material provided to assist primary care physicians in drug uptitration
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual communication strategy from cardiologist to primary care physician: uptitration advised but no active support nor educational material provided
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
achievement of ≥ 50% of the target dose of both beta-blockers and ACE-inhibitors or angiotensin-receptor blockers
Time Frame
12 weeks
Title
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
Title
all cause death, hospital admissions, emergency room visits; changes in quality of life by SF12, a generic questionnaire
Time Frame
12 weeks
Title
value of DRG reimbursement for hospital admissions and specialist visits
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Di Lenarda, MD
Organizational Affiliation
Cardiovascular Center ASS 1 Triestina, Trieste Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fabrizio Oliva, MD
Organizational Affiliation
Heart Failure Heart Transplant Program, Cardiovascular Department, Niguarda Hospital, Milan, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Azienda Opsedaliera Ospedale Niguarda Ca' Granda
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy

12. IPD Sharing Statement

Links:
URL
http://www.anmco.it
Description
official website of the Study Sponsor Italian Association of Hospital Cardiologists

Learn more about this trial

Strategies to Improve Prescribing in Heart Failure Patients

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