Chronic Heart FailureNCT01023438
Strategies to Improve Prescribing in Heart Failure Patients
A study testing Strategy for assisted uptitration in people with Chronic Heart Failure, run by Niguarda Hospital at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Strategy for assisted uptitration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Chronic Heart Failure
- Being tested
- Strategy for assisted uptitration, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategy for assisted uptitrationOther
Active specialist support (mail, phone) and educational material provided to assist primary care physicians in drug uptitration
Usual careOther
Usual communication strategy from cardiologist to primary care physician: uptitration advised but no active support nor educational material provided
| Study group | Role | What they receive |
|---|---|---|
| Assisted uptitration | Experimental | Uptitration of recommended drugs by primary care physician with specialist support Receives: Other: Strategy for assisted uptitration |
| Usual care | Active comparator | Usual communication strategy from cardiologist to primary care physician Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (4)
achievement of ≥ 50% of the target dose of both beta-blockers and ACE-inhibitors or angiotensin-receptor blockers
Measured: 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
Measured: 12 weeks
all cause death, hospital admissions, emergency room visits; changes in quality of life by SF12, a generic questionnaire
Measured: 12 weeks
value of DRG reimbursement for hospital admissions and specialist visits
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2017
Why it stopped: Up to sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Centre for Disease Prevention and Control, Associazione Nazionale Medici Cardiologi Ospedalieri
- Responsible party
- Sponsor
- Investigators
- Andrea Di Lenarda, MD, Study chair, Cardiovascular Center ASS 1 Triestina, Trieste ItalyFabrizio Oliva, MD, Study chair, Heart Failure Heart Transplant Program, Cardiovascular Department, Niguarda Hospital, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023438
- Sponsor's protocol ID
- SMART SC
- Status last verified
- Jun 2018
- First submitted
- 30 Nov 2009
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01023438
- Acronym / sponsor ID
- SMART SC
- Conditions
- Chronic Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Up to sponsor decision
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Collaborators
- National Centre for Disease Prevention and Control, Associazione Nazionale Medici Cardiologi Ospedalieri
- Study start
- Jan 2010 (actual)
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assisted uptitration | Experimental | Other: Strategy for assisted uptitrationUptitration of recommended drugs by primary care physician with specialist support |
| Usual care | Active comparator | Other: Usual careUsual communication strategy from cardiologist to primary care physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strategy for assisted uptitrationActive specialist support (mail, phone) and educational material provided to assist primary care physicians in drug uptitration | Other | Assisted uptitration |
| Usual careUsual communication strategy from cardiologist to primary care physician: uptitration advised but no active support nor educational material provided | Other | Usual care |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Up to sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- official website of the Study Sponsor Italian Association of Hospital CardiologistsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Di Lenarda, MD study chair
Cardiovascular Center ASS 1 Triestina, Trieste Italy
Fabrizio Oliva, MD study chair
Heart Failure Heart Transplant Program, Cardiovascular Department, Niguarda Hospital, Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategy for assisted uptitration in people with Chronic Heart Failure, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Up to sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.