Heart FailurePhase 4TOPHUNCT01662323
Study to Improve the Treatment of Patients With Heart Failure by General Practitioners
A Phase 4 study testing GP's treating HF according the dutch guidelines in people with Heart Failure, run by Julius Center.
Trial summary
The purpose of this study is to determine whether it is possible to improve the care of general practitioners for patients with heart failure. The investigators try to reach that goal by training the GP's for 90 minutes in uptitrating the recommended medication according the guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- GP's treating HF according the dutch guidelines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 683 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jun 2012
- Phase
- Phase 4
- 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
- Do have a general practitioners diagnosis heart failure mentioned twice in the electronical medical file.
Who cannot join
- Incapacitated patients with a life expectancy of less than 2 months
- Seniles
- Patients who do not speak the Dutch language
About this study
Official title: Therapy OPtimization Heart Failure Utrecht
The purpose of this study is to determine whether it is possible to improve the care of general practitioners for patients with heart failure. The investigators try to reach that goal by training the GP's for 90 minutes in uptitrating the recommended medication according the guidelines. After 6 month the investigators ask the patients to fill out a questionary. The investigators ask them about their quality of live.
- Conditions
- Heart Failure
- Being tested
- GP's treating HF according the dutch guidelines
- Keywords
- Heart failure, general practitioner, medical therapy, quality of live
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP's treating HF according the dutch guidelinesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Training of the GP's, intervention | Active comparator | General practitioners are trained to diagnose and treat heart failure according the recommendations of the NHG-standard. Receives: Behavioral: GP's treating HF according the dutch guidelines |
| Controle | Active comparator | General practitioners giving care as usual to their heart failure patients. Receives: Behavioral: GP's treating HF according the dutch guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion recommended medication for patients with heart failure
the proportion patient who got at the end of the study the tree medicaments which should be prescribed to a patient with heart failure.
Measured: up to 6 months
Secondary outcomes (1)
QoL
Measurement of quality of live six months after uptitration of the recommended medication.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startJun 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 683 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julius Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agis Zorgverzekeringen
- Responsible party
- Principal investigator, Drs. Mark M J Valk, Julius Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662323
- Sponsor's protocol ID
- TOPHU01
- Acronym
- TOPHU
- Status last verified
- Nov 2012
- First submitted
- 2 Aug 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Valk MJ, Hoes AW, Mosterd A, Landman MA, Broekhuizen BD, Rutten FH. Rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study: a cluster randomised controlled trial. BMC Fam Pract. 2015 Oct 7;16:130. doi: 10.1186/s12875-015-0347-1.
PubMed 26446696Valk MJ, Broekhuizen BD, Mosterd A, Zuithoff NP, Hoes AW, Rutten FH. COPD in patients with stable heart failure in the primary care setting. Int J Chron Obstruct Pulmon Dis. 2015 Jun 26;10:1219-24. doi: 10.2147/COPD.S77085. eCollection 2015.
PubMed 26170650
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy OPtimization Heart Failure Utrecht
- ClinicalTrials.gov ID
- NCT01662323
- Acronym / sponsor ID
- TOPHU / TOPHU01
- Conditions
- Heart Failure
- Keywords
- Heart failure, general practitioner, medical therapy, quality of live
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 683 participants (actual)
- Lead sponsor
- Julius CenterUniversity, hospital or other
- Collaborators
- Agis Zorgverzekeringen
- Study start
- Jun 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Aug 2012 (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 this study is to determine whether it is possible to improve the care of general practitioners for patients with heart failure. The investigators try to reach that goal by training the GP's for 90 minutes in uptitrating the recommended medication according the guidelines. After 6 month the investigators ask the patients to fill out a questionary. The investigators ask them about their quality of live.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training of the GP's, intervention | Active comparator | Behavioral: GP's treating HF according the dutch guidelinesGeneral practitioners are trained to diagnose and treat heart failure according the recommendations of the NHG-standard. |
| Controle | Active comparator | Behavioral: GP's treating HF according the dutch guidelinesGeneral practitioners giving care as usual to their heart failure patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Do have a general practitioners diagnosis heart failure mentioned twice in the electronical medical file.
Key exclusion criteria (3 listed)
- Incapacitated patients with a life expectancy of less than 2 months
- Seniles
- Patients who do not speak the Dutch language
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 |
|---|---|---|
| GP's treating HF according the dutch guidelines | Behavioural | Controle, Training of the GP's, intervention |
Primary outcome
proportion recommended medication for patients with heart failure
Time frame: up to 6 months
the proportion patient who got at the end of the study the tree medicaments which should be prescribed to a patient with heart failure.
1 secondary outcome
QoL
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
- Derived from this study: PubMed 26446696Valk MJ, Hoes AW, Mosterd A, Landman MA, Broekhuizen BD, Rutten FH. Rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study: a cluster randomised controlled trial. BMC Fam Pract. 2015 Oct 7;16:130. doi: 10.1186/s12875-015-0347-1.
- Derived from this study: PubMed 26170650Valk MJ, Broekhuizen BD, Mosterd A, Zuithoff NP, Hoes AW, Rutten FH. COPD in patients with stable heart failure in the primary care setting. Int J Chron Obstruct Pulmon Dis. 2015 Jun 26;10:1219-24. doi: 10.2147/COPD.S77085. eCollection 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GP's treating HF according the dutch guidelines in people with Heart Failure, run by Julius Center.
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 1 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: finished, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
proportion recommended medication for patients with heart failure (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01662323, which also lists 2 linked publications.
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 14 Nov 2012.