Heart FailurePhase 2/3NCT00182182
Evaluation of a Primary Care Based Heart Failure Management Program
A Phase 2/3 study testing Primary care based disease management strategy in people with Heart Failure, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Evaluation of a primary care based (family physicians) HF management strategy in patients with heart failure in the community 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?
- Primary care based disease management strategy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2003to Oct 2006
- Phase
- Phase 2/3
- 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
- Men and women, age more or equal to 65 years AND
- Diagnosis of HF confirmed with the following criteria:
- Previous hospital admission for HF OR
- Definite HF confirmed with the Boston HF criteria OR
- Possible HF confirmed with the Boston HF criteria AND evidence of left ventricular systolic dysfunction (left ventricular ejection function <40%) on echocardiography, radionuclide angiography, or left ventricular angiogram documented in the patient's family physicians clinic chart.
Who cannot join
- Patients with terminal illness (e.g. cancer) with a life expectancy of less than one year.
- Patients in a long-term-care facility with nursing care.
- Patients awaiting cardiac surgery for correctable causes of HF (e.g., severe valvular disease or extensive ischemia) during the study period.
- Patients expected to be away from the country during the intervention period for a duration of >3 months.
- Patients unable or refusing to sign consent.
- Patients currently followed in the Hamilton Health Sciences HF clinic. These patients are excluded as they are currently enrolled in a HF disease management strategy.
- Patients currently enrolled in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Congestive Heart Failure Assessment and Management in Primary Care: CHAMP
Evaluation of a primary care based (family physicians) HF management strategy in patients with heart failure in the community
Read the detailed description
Cluster randomized clinical trial (family physician is cluster) evaluating a primary care based heart failure management strategy
- Conditions
- Heart Failure
- Being tested
- Primary care based disease management strategy
- Keywords
- Heart Failure, Family physicians, academic detailing, process of care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary care based disease management strategyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Process-of-care composite score assessed at baseline, at 6 months for effectiveness of the intervention, and at 12 months for sustainability of the effect. The score includes assessment of:
ACE-inhibitor use unless contraindicated,ACE-inhibitor dosage is at >50% of clinical trial target dose,Beta-blocker use unless contraindicated.
Each component of the score will be given one point.
Secondary outcomes (9)
Disease specific quality of life (QOL)with Minnessota Living with Heart Failure.
NYHA functional class.
Other outcomes
All-cause hospitalization defined as > 24-hour hospital stay including the time spent in the emergency room.
Hospitalizations for HF: > 24-hour hospital stay including the time spent in the emergency room with clinical evidence of HF including at least one of the following: increased dyspnea on exertion, orthopnea, nocturnal dyspnea, elevated jugular venous
Emergency room visits for deterioration of HF requiring IV or additional PO diuretics: <24-hour stay in hospital/emergency room with clinical evidence of HF.
Referral to Hamilton Health Sciences HF clinic or other institution.
Quality adjusted survival
Overall costs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2003
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Investigators
- Catherine Demers, MD, MSc, FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182182
- Sponsor's protocol ID
- HSF2004h00511
- Status last verified
- Sep 2006
- First submitted
- 12 Sep 2005
- Last updated
- 11 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congestive Heart Failure Assessment and Management in Primary Care: CHAMP
- ClinicalTrials.gov ID
- NCT00182182
- Acronym / sponsor ID
- HSF2004h00511
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Family physicians, academic detailing, process of care
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Jul 2003
- Study completion
- Oct 2006
- First posted
- 16 Sep 2005 (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.
Evaluation of a primary care based (family physicians) HF management strategy in patients with heart failure in the community
Detailed description
Cluster randomized clinical trial (family physician is cluster) evaluating a primary care based heart failure management strategy
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women, age more or equal to 65 years AND
- Diagnosis of HF confirmed with the following criteria:
Key exclusion criteria (7 listed)
- Patients with terminal illness (e.g. cancer) with a life expectancy of less than one year.
- Patients in a long-term-care facility with nursing care.
- Patients awaiting cardiac surgery for correctable causes of HF (e.g., severe valvular disease or extensive ischemia) during the study period.
- Patients expected to be away from the country during the intervention period for a duration of >3 months.
- Patients unable or refusing to sign consent.
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 |
|---|---|---|
| Primary care based disease management strategy | Behavioural | – |
Primary outcome
Process-of-care composite score assessed at baseline, at 6 months for effectiveness of the intervention, and at 12 months for sustainability of the effect. The score includes assessment of:
ACE-inhibitor use unless contraindicated,ACE-inhibitor dosage is at >50% of clinical trial target dose,Beta-blocker use unless contraindicated.
Each component of the score will be given one point.
9 secondary outcomes
Disease specific quality of life (QOL)with Minnessota Living with Heart Failure.
NYHA functional class.
Other outcomes
All-cause hospitalization defined as > 24-hour hospital stay including the time spent in the emergency room.
Hospitalizations for HF: > 24-hour hospital stay including the time spent in the emergency room with clinical evidence of HF including at least one of the following: increased dyspnea on exertion, orthopnea, nocturnal dyspnea, elevated jugular venous
Emergency room visits for deterioration of HF requiring IV or additional PO diuretics: <24-hour stay in hospital/emergency room with clinical evidence of HF.
Referral to Hamilton Health Sciences HF clinic or other institution.
Quality adjusted survival
Overall costs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2006.
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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.
Catherine Demers, MD, MSc, FRCPC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Primary care based disease management strategy in people with Heart Failure, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Sep 2006. 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 Canada. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Process-of-care composite score assessed at baseline, at 6 months for effectiveness of the intervention, and at 12 months for sustainability of the effect. The score includes assessment of:. The study lists 3 primary outcomes in all. 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 11 Sep 2006.