Heart FailureTREENCT01148719
Triage of Reduced Exercise Tolerance in Frail Elderly
A study testing Index group in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Background of the study: Many elderly suffer from reduced exercise tolerance or exercise induced shortness of breath (dyspnoea) which causes decreased mobility and restrictions in physical, psychological and social functioning. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Index group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 841 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2010to Sep 2012
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients aged 65 years and older
- must have a minimum of three chronic or vitality threatening diseases and/or use five or more medical drugs chronically in the last year
- must have dyspnea and/or reduced exercise tolerance (scored by two short questionnaires)
Who cannot join
- patients with both confirmed COPD and heart failure (Spirometry performed < 1 year ago and heart failure confirmed by echocardiography)
- patients unable or unwilling to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Background of the study:
Many elderly suffer from reduced exercise tolerance or exercise induced shortness of breath (dyspnoea) which causes decreased mobility and restrictions in physical, psychological and social functioning. Patients commonly attribute this symptom to their age, and simply adjust their life style to it. Reduced exercise tolerance/dyspnoea is very common with prevalence rate of 20-60% of those aged 65 years and over. The main causus in the elderly are heart failure and chronic obstructive pulmonary disease (COPD). Both diseases have a high negative impact on the quality of life and are associated with frequent hospital admissions. Over-diagnosis, but more often under-diagnosis of heart failure and COPD is rather common in primary care. Establishing a diagnosis early in the course of the disease is useful because both diseases can be adequately and evidence-based treated. Therefore, an easy diagnostic triage-strategy followed bij direct treatment would be of great importance to asses and treat heart failure and COPD in elderly patient with shortness of breath.
Read more
Objective of the study:
Quantify how many frail elderly aged over 65 years with reduced exercise tolerance and/or exercise induced dyspnoea have previously unrecognised COPD and heart failure. Quantify the difference in prevalence of unrecognised COPD and heart failure between those who underwent the diagnostic triage compared to those who received care as usual. Quantify the effect of the diagnostic triage plus the additionally treatment changes on functionality and quality of life after 6 months compared to those who received care as usual. Quantify the cost-effectiveness of the diagnostic triage strategy compared to care as usual
Study design:
A clustered randomized diagnostic (follow-up) study
Study population:
First, pre-selection of patients aged over 65 years from 50 general practices is based on frailty. Frailty is based on the next criteria: use 5 or more different types of medical drugs chronically in the last year and/or have 3 or more chronic or vitality treating diseases (such as diabetes mellitus, COPD, heart failure, impaired vision). This will be done from the electronic medical files of the general practices. These elderly will receive the MRC questionnaire of dyspnoea and three additional questions related tot exercise intolerance. Those with any dyspnoea and/or reduced exercise tolerance will be invited to participate, except those with established heart failure and COPD.
Study parameters/outcome of the study:
Prevalence of latent heart failure and COPD. Difference in prevalence of latent heart failure and COPD between both groups.
Differences in functionality and quality of life after 6 months between both groups. Cost-effectiveness and experienced patient burden of the diagnostic triage strategy.
- Being tested
- Index group
- Keywords
- Heart Failure, Chronic Obstructive Pulmonary Disease, Dyspnea, Elderly, Diagnosis, Primary health care
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Dyspnea, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Index groupOther
Also called Diagnostic triage strategy
Diagnostic triage strategy includes; electrocardiography, echocardiography, spirometry and blood testing
| Study group | Role | What they receive |
|---|---|---|
| Index group | Active comparator | Patients in the index group receive the diagnostic triage instrument. This includes echocardiographic, electrocardiographic and spirometric measurements and blood testing. Receives: Other: Index group |
| Control | No intervention | Participants receive care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of latent heart failure and COPD.
Prevalence of latent heart failure and COPD. The prevalence in the index-group is calculated after all investigations are done. The prevalence in de control-group is derived from the electronical medical files of the general practitioner after a follow-up period of six months.
Measured: 6 months
Secondary outcomes (2)
Effectiveness of the diagnostic triage strategy
(Cost-)effectiveness of the diagnostic triage strategy.
Measured: 6 months
Difference in prevalence of latent heart failure and COPD between both groups
Difference in prevalence of latent heart failure and COPD between both groups. The prevalence in index-group is calculated after all investigations are done. The prevalence in de control-group is derived from the electronical medical files of the general practitioner after a follow-up period of six months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 841 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, F.H. Rutten, UMC Utrecht
- Investigators
- Frans H Rutten, Dr., Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148719
- Sponsor's protocol ID
- 311040302
- Other IDs
- NL30278.041.10, NTR2336
- Acronym
- TREE
- Status last verified
- Jul 2014
- First submitted
- 17 Jun 2010
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
PubMed 17132052Mulrow CD, Lucey CR, Farnett LE. Discriminating causes of dyspnea through clinical examination. J Gen Intern Med. 1993 Jul;8(7):383-92. doi: 10.1007/BF02600079. No abstract available.
PubMed 8410400Landahl S, Steen B, Svanborg A. Dyspnea in 70-year-old people. Acta Med Scand. 1980;207(3):225-30. doi: 10.1111/j.0954-6820.1980.tb09710.x.
PubMed 7368988Hogg K, Swedberg K, McMurray J. Heart failure with preserved left ventricular systolic function; epidemiology, clinical characteristics, and prognosis. J Am Coll Cardiol. 2004 Feb 4;43(3):317-27. doi: 10.1016/j.jacc.2003.07.046.
PubMed 15013109Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.
PubMed 17507545Rutten FH, Cramer MJ, Grobbee DE, Sachs AP, Kirkels JH, Lammers JW, Hoes AW. Unrecognized heart failure in elderly patients with stable chronic obstructive pulmonary disease. Eur Heart J. 2005 Sep;26(18):1887-94. doi: 10.1093/eurheartj/ehi291. Epub 2005 Apr 28.
PubMed 15860516Swedberg K, Cleland J, Dargie H, Drexler H, Follath F, Komajda M, Tavazzi L, Smiseth OA, Gavazzi A, Haverich A, Hoes A, Jaarsma T, Korewicki J, Levy S, Linde C, Lopez-Sendon JL, Nieminen MS, Pierard L, Remme WJ; Task Force for the Diagnosis and Treatment of Chronic Heart Failure of the European Society of Cardiology. Guidelines for the diagnosis and treatment of chronic heart failure: executive summary (update 2005): The Task Force for the Diagnosis and Treatment of Chronic Heart Failure of the European Society of Cardiology. Eur Heart J. 2005 Jun;26(11):1115-40. doi: 10.1093/eurheartj/ehi204. Epub 2005 May 18. No abstract available.
PubMed 15901669Rutten FH, Cramer MJ, Lammers JW, Grobbee DE, Hoes AW. Heart failure and chronic obstructive pulmonary disease: An ignored combination? Eur J Heart Fail. 2006 Nov;8(7):706-11. doi: 10.1016/j.ejheart.2006.01.010. Epub 2006 Mar 13.
PubMed 16531114Remes J, Miettinen H, Reunanen A, Pyorala K. Validity of clinical diagnosis of heart failure in primary health care. Eur Heart J. 1991 Mar;12(3):315-21. doi: 10.1093/oxfordjournals.eurheartj.a059896.
PubMed 2040313Bednarek M, Maciejewski J, Wozniak M, Kuca P, Zielinski J. Prevalence, severity and underdiagnosis of COPD in the primary care setting. Thorax. 2008 May;63(5):402-7. doi: 10.1136/thx.2007.085456. Epub 2008 Jan 30.
PubMed 18234906Wheeldon NM, MacDonald TM, Flucker CJ, McKendrick AD, McDevitt DG, Struthers AD. Echocardiography in chronic heart failure in the community. Q J Med. 1993 Jan;86(1):17-23.
PubMed 8438044Geijer RM, Sachs AP, Hoes AW, Salome PL, Lammers JW, Verheij TJ. Prevalence of undetected persistent airflow obstruction in male smokers 40-65 years old. Fam Pract. 2005 Oct;22(5):485-9. doi: 10.1093/fampra/cmi049. Epub 2005 Jun 17.
PubMed 15964866Rutten FH, Moons KG, Cramer MJ, Grobbee DE, Zuithoff NP, Lammers JW, Hoes AW. Recognising heart failure in elderly patients with stable chronic obstructive pulmonary disease in primary care: cross sectional diagnostic study. BMJ. 2005 Dec 10;331(7529):1379. doi: 10.1136/bmj.38664.661181.55. Epub 2005 Dec 1.
PubMed 16321994McHorney CA, Ware JE Jr, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993 Mar;31(3):247-63. doi: 10.1097/00005650-199303000-00006.
PubMed 8450681Aaronson NK, Muller M, Cohen PD, Essink-Bot ML, Fekkes M, Sanderman R, Sprangers MA, te Velde A, Verrips E. Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol. 1998 Nov;51(11):1055-68. doi: 10.1016/s0895-4356(98)00097-3.
PubMed 9817123
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triage of Reduced Exercise Tolerance in Frail Elderly
- ClinicalTrials.gov ID
- NCT01148719
- Acronym / sponsor ID
- TREE / 311040302
- Keywords
- Heart Failure, Chronic Obstructive Pulmonary Disease, Dyspnea, Elderly, Diagnosis, Primary health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 841 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Jun 2010 (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.
Background of the study:
Many elderly suffer from reduced exercise tolerance or exercise induced shortness of breath (dyspnoea) which causes decreased mobility and restrictions in physical, psychological and social functioning. Patients commonly attribute this symptom to their age, and simply adjust their life style to it. Reduced exercise tolerance/dyspnoea is very common with prevalence rate of 20-60% of those aged 65 years and over. The main causus in the elderly are heart failure and chronic obstructive pulmonary disease (COPD). Both diseases have a high negative impact on the quality of life and are associated with frequent hospital admissions. Over-diagnosis, but more often under-diagnosis of heart failure and COPD is rather common in primary care. Establishing a diagnosis early in the course of the disease is useful because both diseases can be adequately and evidence-based treated. Therefore, an easy diagnostic triage-strategy followed bij direct treatment would be of great importance to asses and treat heart failure and COPD in elderly patient with shortness of breath.
Objective of the study:
Quantify how many frail elderly aged over 65 years with reduced exercise tolerance and/or exercise induced dyspnoea have previously unrecognised COPD and heart failure. Quantify the difference in prevalence of unrecognised COPD and heart failure between those who underwent the diagnostic triage compared to those who received care as usual. Quantify the effect of the diagnostic triage plus the additionally treatment changes on functionality and quality of life after 6 months compared to those who received care as usual. Quantify the cost-effectiveness of the diagnostic triage strategy compared to care as usual
Study design:
A clustered randomized diagnostic (follow-up) study
Study population:
First, pre-selection of patients aged over 65 years from 50 general practices is based on frailty. Frailty is based on the next criteria: use 5 or more different types of medical drugs chronically in the last year and/or have 3 or more chronic or vitality treating diseases (such as diabetes mellitus, COPD, heart failure, impaired vision). This will be done from the electronic medical files of the general practices. These elderly will receive the MRC questionnaire of dyspnoea and three additional questions related tot exercise intolerance. Those with any dyspnoea and/or reduced exercise tolerance will be invited to participate, except those with established heart failure and COPD.
Study parameters/outcome of the study:
Prevalence of latent heart failure and COPD. Difference in prevalence of latent heart failure and COPD between both groups.
Differences in functionality and quality of life after 6 months between both groups. Cost-effectiveness and experienced patient burden of the diagnostic triage strategy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Index group | Active comparator | Other: Index groupPatients in the index group receive the diagnostic triage instrument. This includes echocardiographic, electrocardiographic and spirometric measurements and blood testing. |
| Control | No intervention | –Participants receive care as usual. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- patients aged 65 years and older
- must have a minimum of three chronic or vitality threatening diseases and/or use five or more medical drugs chronically in the last year
- must have dyspnea and/or reduced exercise tolerance (scored by two short questionnaires)
Key exclusion criteria (2 listed)
- patients with both confirmed COPD and heart failure (Spirometry performed < 1 year ago and heart failure confirmed by echocardiography)
- patients unable or unwilling to sign informed 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 |
|---|---|---|
| Index groupAlso: Diagnostic triage strategyDiagnostic triage strategy includes; electrocardiography, echocardiography, spirometry and blood testing | Other | Index group |
Primary outcome
Prevalence of latent heart failure and COPD.
Time frame: 6 months
Prevalence of latent heart failure and COPD. The prevalence in the index-group is calculated after all investigations are done. The prevalence in de control-group is derived from the electronical medical files of the general practitioner after a follow-up period of six months.
2 secondary outcomes
Effectiveness of the diagnostic triage strategy
Time frame: 6 months
Difference in prevalence of latent heart failure and COPD between both groups
Time frame: 6 months
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 8 Jul 2014.
- Background: PubMed 17132052Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
- Background: PubMed 8410400Mulrow CD, Lucey CR, Farnett LE. Discriminating causes of dyspnea through clinical examination. J Gen Intern Med. 1993 Jul;8(7):383-92. doi: 10.1007/BF02600079. No abstract available.
- Background: PubMed 7368988Landahl S, Steen B, Svanborg A. Dyspnea in 70-year-old people. Acta Med Scand. 1980;207(3):225-30. doi: 10.1111/j.0954-6820.1980.tb09710.x.
- Background: PubMed 15013109Hogg K, Swedberg K, McMurray J. Heart failure with preserved left ventricular systolic function; epidemiology, clinical characteristics, and prognosis. J Am Coll Cardiol. 2004 Feb 4;43(3):317-27. doi: 10.1016/j.jacc.2003.07.046.
- Background: PubMed 17507545Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.
- Background: PubMed 15860516Rutten FH, Cramer MJ, Grobbee DE, Sachs AP, Kirkels JH, Lammers JW, Hoes AW. Unrecognized heart failure in elderly patients with stable chronic obstructive pulmonary disease. Eur Heart J. 2005 Sep;26(18):1887-94. doi: 10.1093/eurheartj/ehi291. Epub 2005 Apr 28.
- Background: PubMed 15901669Swedberg K, Cleland J, Dargie H, Drexler H, Follath F, Komajda M, Tavazzi L, Smiseth OA, Gavazzi A, Haverich A, Hoes A, Jaarsma T, Korewicki J, Levy S, Linde C, Lopez-Sendon JL, Nieminen MS, Pierard L, Remme WJ; Task Force for the Diagnosis and Treatment of Chronic Heart Failure of the European Society of Cardiology. Guidelines for the diagnosis and treatment of chronic heart failure: executive summary (update 2005): The Task Force for the Diagnosis and Treatment of Chronic Heart Failure of the European Society of Cardiology. Eur Heart J. 2005 Jun;26(11):1115-40. doi: 10.1093/eurheartj/ehi204. Epub 2005 May 18. No abstract available.
- Background: PubMed 16531114Rutten FH, Cramer MJ, Lammers JW, Grobbee DE, Hoes AW. Heart failure and chronic obstructive pulmonary disease: An ignored combination? Eur J Heart Fail. 2006 Nov;8(7):706-11. doi: 10.1016/j.ejheart.2006.01.010. Epub 2006 Mar 13.
- Background: PubMed 2040313Remes J, Miettinen H, Reunanen A, Pyorala K. Validity of clinical diagnosis of heart failure in primary health care. Eur Heart J. 1991 Mar;12(3):315-21. doi: 10.1093/oxfordjournals.eurheartj.a059896.
- Background: PubMed 18234906Bednarek M, Maciejewski J, Wozniak M, Kuca P, Zielinski J. Prevalence, severity and underdiagnosis of COPD in the primary care setting. Thorax. 2008 May;63(5):402-7. doi: 10.1136/thx.2007.085456. Epub 2008 Jan 30.
- Background: PubMed 8438044Wheeldon NM, MacDonald TM, Flucker CJ, McKendrick AD, McDevitt DG, Struthers AD. Echocardiography in chronic heart failure in the community. Q J Med. 1993 Jan;86(1):17-23.
- Background: PubMed 15964866Geijer RM, Sachs AP, Hoes AW, Salome PL, Lammers JW, Verheij TJ. Prevalence of undetected persistent airflow obstruction in male smokers 40-65 years old. Fam Pract. 2005 Oct;22(5):485-9. doi: 10.1093/fampra/cmi049. Epub 2005 Jun 17.
- study protocolLink 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.
Frans H Rutten, Dr. principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Index group in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by UMC Utrecht at 1 site in Netherlands.
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 2 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 8 Jul 2014. 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 Netherlands. 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?
Prevalence of latent heart failure and COPD. (time frame: 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 NCT01148719, which also lists 24 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 8 Jul 2014.