Heart FailureZOPANNCT00953810
Educational Intervention in Heart Failure Patients
A study testing Educational training regarding heart failure in people with Heart Failure, run by National Institute of Cardiology, Warsaw, Poland at 10 sites in Poland.
Trial summary
The main aim of this randomized study was to evaluate the effect of educational intervention on patients with heart failure and their care-giver with regard to patients' prognosis. 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?
- Educational training regarding heart failure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 822 participants
- Where
- 10 sitesPoland
- Study dates
- Apr 2004to Jan 2008
- 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
- Symptoms of heart failure
- EF < 45% (during past 2 years) or abnormal ECG and chest x-ray when echo unavailable
- Age > 18 years
- Signed informed consent
Who cannot join
- Severe COPD
- Serious comorbidities, influencing life expectancy or quality of life
- Alcohol and drug addict
- Post MI less than 6 months
- Dementia
- Living in home nursing facilities
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Poland10 sites
Oddział Kardiologiczny Szpital Wojewódzki
Ciechanów
- Klinika Chorób Wewnętrznych I Rehabilitacji Kardiologicznej
Gdansk
Oddział Wewnętrzny Szpital Rejonowy
Grójec
Oddział Kardiologii Szpital Wojewódzki
Koszalin
- KATEDRA CHORÓB WEWNĘTRZNYCH i GERONTOLOGII
Krakow
Oddział Kardiologiczno-Internistyczny Miejski Szpital Zespolony
Olsztyn
Ii Klinika Kardiologii A.M
Poznan
Oddział Kardiologiczny Radomski Szpital Specjalistyczny
Radom
Oddział Kardiologiczny Samodzielny Specjalistyczny Szpital Wojewódzki
Siedlce
Heart Failure and Transplantology Department Institute of Cardiology
Warsaw, Alpejska 42, 04-628
About this study
Official title: RandomiZed AmbulatOry Interventional ProgrAm in Heart Failure PatieNts (ZOPAN)
The main aim of this randomized study was to evaluate the effect of educational intervention on patients with heart failure and their care-giver with regard to patients' prognosis.
Read the detailed description
Part I: This is a multicenter study on the effect of educational intervention on heart failure patients and their caregivers with respect to patients' prognosis, social support and quality of life. Subsequent patients with heart failure (based on the inclusion criteria) coming to selected, ambulatory physician, were randomized to either a control or intervention group. Both groups underwent questionnaire evaluation regarding clinical assessment and evaluation of familiarity with aspects of heart failure along with social support and quality of life. Clinical assessment included information on demography, social status, medical history, pharmacotherapy, diagnostic procedures, and utilization of health system resources. After recruitment, patients from intervention group and their caregivers underwent one educational training, during which they received materials on the management of heart failure. Before the meeting, data on familiarity with heart failure were acquired from patients' relatives. During further follow up all participants stayed under regular care from their ambulatory physicians. After 6 months patients underwent short term evaluation based on designated questionnaires, with special attention paid to hospitalization and ambulatory visits due to heart failure. Also data on heart failure knowledge, social support and quality of life was collected. Without any further intervention, follow up was continued. Next long term assessment was undertaken after approximately 3 years from the recruitment. As previously patients fulfilled questionnaires regarding information on their familiarity with heart failure management and social support as well as quality of life. Primary end points of the study were: death, hospitalization (including cardiovascular hospitalizations) and ambulatory visits. Secondary end points included social support and quality of life.
Sub-study: genetic polymorphism - blood specimens collected during one of the visits and stored for further evaluation in future. Study population - all main study participants who gave their informed consent to this part of protocol. Aims: to describe the potential of selected genes candidates polymorphism on the heart failure prognosis and survival in patients NYHA class II-IV.
- Conditions
- Heart Failure
- Being tested
- Educational training regarding heart failure
- Keywords
- heart failure, education, non-pharmacological management, prognosis
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational training regarding heart failureOther
Also called education
Like control plus one education training regarding heart failure aspects and management
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | General heart failure population staying under regular care of their primary care physician |
| Intervention | Active comparator | Like control plus one education training regarding heart failure aspects and management Receives: Other: Educational training regarding heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary end points of the study were: death, hospitalization (including cardiovascular hospitalisation)and ambulatory visits.
Measured: 6 months and 3 years
Secondary outcomes (1)
Secondary end points included social support and quality of life.
Measured: 6 months and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startApr 2004
- Primary completionNov 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 822 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Investigators
- Tomasz M Rywik, MD, Study director, Heart Failure and Transplantology Department Institute of CardiologyJerzy Korewicki, Md, Ph.D, Principal investigator, Heart Failure and Transplantology DepartmentWojciech Drygas, MD, Ph.D, Principal investigator, Department of Cardiovascular Epidemiology and Prevention Institute of CardiologyGrażyna Broda, MD, Ph.D, Principal investigator, Department of Cardiovascular Epidemiology and Prevention Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953810
- Sponsor's protocol ID
- 7/115/2003/101/1304
- Acronym
- ZOPAN
- Status last verified
- Aug 2009
- First submitted
- 5 Aug 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Rywik TM, Kolodziej P, Targonski R, Fedyk-Lukasik M, Nowicka A, Zinka E, Zbyszynski B, Achremczyk P, Gorski J, Muder A, Sadowski J, Leszek P, Kurjata P, Broda G, Korewicki J. Characteristics of the heart failure population in Poland: ZOPAN, a multicentre national programme. Kardiol Pol. 2011;69(1):24-31.
PubMed 21267960
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RandomiZed AmbulatOry Interventional ProgrAm in Heart Failure PatieNts (ZOPAN)
- ClinicalTrials.gov ID
- NCT00953810
- Acronym / sponsor ID
- ZOPAN / 7/115/2003/101/1304
- Conditions
- Heart Failure
- Keywords
- heart failure, education, non-pharmacological management, prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 822 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 6 Aug 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 main aim of this randomized study was to evaluate the effect of educational intervention on patients with heart failure and their care-giver with regard to patients' prognosis.
Detailed description
Part I: This is a multicenter study on the effect of educational intervention on heart failure patients and their caregivers with respect to patients' prognosis, social support and quality of life. Subsequent patients with heart failure (based on the inclusion criteria) coming to selected, ambulatory physician, were randomized to either a control or intervention group. Both groups underwent questionnaire evaluation regarding clinical assessment and evaluation of familiarity with aspects of heart failure along with social support and quality of life. Clinical assessment included information on demography, social status, medical history, pharmacotherapy, diagnostic procedures, and utilization of health system resources. After recruitment, patients from intervention group and their caregivers underwent one educational training, during which they received materials on the management of heart failure. Before the meeting, data on familiarity with heart failure were acquired from patients' relatives. During further follow up all participants stayed under regular care from their ambulatory physicians. After 6 months patients underwent short term evaluation based on designated questionnaires, with special attention paid to hospitalization and ambulatory visits due to heart failure. Also data on heart failure knowledge, social support and quality of life was collected. Without any further intervention, follow up was continued. Next long term assessment was undertaken after approximately 3 years from the recruitment. As previously patients fulfilled questionnaires regarding information on their familiarity with heart failure management and social support as well as quality of life. Primary end points of the study were: death, hospitalization (including cardiovascular hospitalizations) and ambulatory visits. Secondary end points included social support and quality of life.
Sub-study: genetic polymorphism - blood specimens collected during one of the visits and stored for further evaluation in future. Study population - all main study participants who gave their informed consent to this part of protocol. Aims: to describe the potential of selected genes candidates polymorphism on the heart failure prognosis and survival in patients NYHA class II-IV.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –General heart failure population staying under regular care of their primary care physician |
| Intervention | Active comparator | Other: Educational training regarding heart failureLike control plus one education training regarding heart failure aspects and management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptoms of heart failure
- EF < 45% (during past 2 years) or abnormal ECG and chest x-ray when echo unavailable
- Age > 18 years
- Signed informed consent
Key exclusion criteria (6 listed)
- Severe COPD
- Serious comorbidities, influencing life expectancy or quality of life
- Alcohol and drug addict
- Post MI less than 6 months
- Dementia
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 |
|---|---|---|
| Educational training regarding heart failureAlso: educationLike control plus one education training regarding heart failure aspects and management | Other | Intervention |
Primary outcome
Primary end points of the study were: death, hospitalization (including cardiovascular hospitalisation)and ambulatory visits.
Time frame: 6 months and 3 years
1 secondary outcome
Secondary end points included social support and quality of life.
Time frame: 6 months and 3 years
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 6 Aug 2009.
- Derived from this study: PubMed 21267960Rywik TM, Kolodziej P, Targonski R, Fedyk-Lukasik M, Nowicka A, Zinka E, Zbyszynski B, Achremczyk P, Gorski J, Muder A, Sadowski J, Leszek P, Kurjata P, Broda G, Korewicki J. Characteristics of the heart failure population in Poland: ZOPAN, a multicentre national programme. Kardiol Pol. 2011;69(1):24-31.
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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.
Tomasz M Rywik, MD study director
Heart Failure and Transplantology Department Institute of Cardiology
Jerzy Korewicki, Md, Ph.D principal investigator
Heart Failure and Transplantology Department
Wojciech Drygas, MD, Ph.D principal investigator
Department of Cardiovascular Epidemiology and Prevention Institute of Cardiology
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational training regarding heart failure in people with Heart Failure, run by National Institute of Cardiology, Warsaw, Poland at 10 sites in Poland.
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 4 inclusion and 6 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 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Poland. 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 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?
Primary end points of the study were: death, hospitalization (including cardiovascular hospitalisation)and ambulatory visits. (time frame: 6 months and 3 years). 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 NCT00953810, which also lists 1 linked publication.
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 6 Aug 2009.