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Strategies to Improve Prescribing in Heart Failure Patients

N

Niguarda Hospital

Status

Terminated

Conditions

Chronic Heart Failure

Treatments

Other: Usual care
Other: Strategy for assisted uptitration

Study type

Interventional

Funder types

Other

Identifiers

NCT01023438
SMART SC

Details and patient eligibility

About

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

Full 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

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Assisted uptitration
Experimental group
Description:
Uptitration of recommended drugs by primary care physician with specialist support
Treatment:
Other: Strategy for assisted uptitration
Usual care
Active Comparator group
Description:
Usual communication strategy from cardiologist to primary care physician
Treatment:
Other: Usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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