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Up to sponsor decision
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| Name | Class |
|---|---|
| National Centre for Disease Prevention and Control | UNKNOWN |
| Associazione Nazionale Medici Cardiologi Ospedalieri | OTHER |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assisted uptitration | Experimental | Uptitration of recommended drugs by primary care physician with specialist support |
|
| Usual care | Active Comparator | Usual communication strategy from cardiologist to primary care physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strategy for assisted uptitration | Other | Active specialist support (mail, phone) and educational material provided to assist primary care physicians in drug uptitration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Opsedaliera Ospedale Niguarda Ca' Granda | Milan | MI | 20162 | Italy |
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| Label | URL |
|---|---|
| official website of the Study Sponsor Italian Association of Hospital Cardiologists | View source |
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| Usual care | Other | Usual communication strategy from cardiologist to primary care physician: uptitration advised but no active support nor educational material provided |
|
| 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 |