Strategies to Improve Prescribing in Heart Failure Patients
This study has suspended participant recruitment.
(Up to sponsor decision)
Sponsor:
Niguarda Hospital
Collaborators:
National Centre for Disease Prevention and Control
Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO)
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
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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
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 (ANMCO)
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 May 21, 2013