Heart FailureDROPSYNCT01013883
The Darlington Retrospective Outpatient Study
An observational study of Heart Failure, run by County Durham and Darlington NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Having heart failure means the heart is unable to pump blood around the body effectively. This reduces life expectancy and hinders normal daily activities. Heart failure affects about one million people in the UK; it is a major cause of death but it is often undetected and under-treated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 509 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Aug 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Secondary care one stop diagnostic heart failure clinic
Who may be able to join
- 18 years and over attending heart failure clinic between 01/01/2002- 31/12/07
Who cannot join
- less than 18 years.
- Pregnant females
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Darlington Memorial Hospital
Darlington, Durham, DL3 6HX
About this study
Official title: Long Term Outcomes in Patients With Heart Failure
Having heart failure means the heart is unable to pump blood around the body effectively. This reduces life expectancy and hinders normal daily activities. Heart failure affects about one million people in the UK; it is a major cause of death but it is often undetected and under-treated. If diagnosed and treated properly, the symptoms of heart failure can be well controlled and the length and quality of life can be improved.
Two drugs (called ACE-inhibitors and beta-blockers) help patients to live longer and suffer fewer consequences of heart failure. These drugs should be offered to all patients although this does not happen consistently for a variety of reasons. Doctors specialising in heart failure may help patients make better informed decisions about treatments and other aspects of care.
The purpose of this research is to explore the diagnosis, management and outcome of patients with heart failure who are referred to the one stop diagnostic heart failure clinic between Jan 2002 and Dec 2007. This study will provide vital information about diagnosis, initiation and titration of evidence based medication in the hospital, their follow in the primary care and subsequent patient outcome in terms of mortality.
Read the detailed description
Case notes of all the patients who were referred to the one stop diagnostic heart failure clinic during the period (Jan 2002- Dec 2007) will be reviewed and subjects who were found to have signs and symptoms of the Heart failure will be identified.
This cohort of patients will be further analysed and divided on the basis of Echocardiography (special scan of the heart that looks at the contraction, relaxation, and the flow of blood in the heart chambers) results into two groups.
- Those who have impaired contraction (systolic) function of there Left ventricle (left side chamber of the heart)
- Those who have normal contraction (systolic) function of the left ventricle.
Case notes of these patients will then be studied in detail with regards to their initial presentation, clinical examination, Electrocardiogram (electrical tracing of the heart) and chest X ray (picture of the heart and lungs) report.
These will be co-related with the findings and report of the Echocardiogram.
Once the diagnosis is established, uptake of evidence based medications (beta blockers, ACE inhibitors, spironolactone) and their titration up to the target dose at subsequent follow up visits in the heart failure clinic will be examined.
- Phase 2 (General practice/ surgery phase)
This part of the study will be conducted at the GP surgery of the identified patient. This will involve accessing the data held at the GP practice with regards to
- Was heart failure treatment continued after discharge from the hospital clinic?
- If medications continued then for how long?
- If medications discontinued then why and by whom (Hospital/GP)?
- Current medications and the doses
- Admissions to the hospital if any?
- Any other co morbidities developed since discharge for the HF clinic?
- Outcome in terms of mortality
- The cause of death as specified on the death certificate
- Conditions
- Heart Failure
- Keywords
- systolic dysfunction, diastolic dysfunction, mortality, treatment, heart rate
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| systolic dysfunction | patients having left ventricular systolic dysfunction on echocardiography | |
| distolic heart failure | patients with clinical heart failure and preserved LV systolic dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cause Mortality
Measured: Patients would be followed up for average of 7 years
Secondary outcomes (2)
Cardiovascular Mortality
Measured: Patients would be followed up for average of 7years
Admission to Hospital for Any Cause
Number of patients admitted to the hospital will be recorded
Measured: During the follow up period of 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- County Durham and Darlington NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Durham
- Responsible party
- Principal investigator, Rajender Singh, County Durham and Darlington NHS Foundation Trust
- Investigators
- Rajender Singh, MD, Principal investigator, county durham and darlington NHS trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013883
- Sponsor's protocol ID
- RajPh.D2066
- Acronym
- DROPSY
- Status last verified
- Jan 2014
- First submitted
- 13 Nov 2009
- Last updated
- 14 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcomes in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01013883
- Acronym / sponsor ID
- DROPSY / RajPh.D2066
- Conditions
- Heart Failure
- Keywords
- systolic dysfunction, diastolic dysfunction, mortality, treatment, heart rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- County Durham and Darlington NHS Foundation TrustOther government
- Collaborators
- University of Durham
- Study start
- Jan 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 16 Nov 2009 (estimated)
- Results
- Posted 14 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Having heart failure means the heart is unable to pump blood around the body effectively. This reduces life expectancy and hinders normal daily activities. Heart failure affects about one million people in the UK; it is a major cause of death but it is often undetected and under-treated. If diagnosed and treated properly, the symptoms of heart failure can be well controlled and the length and quality of life can be improved.
Two drugs (called ACE-inhibitors and beta-blockers) help patients to live longer and suffer fewer consequences of heart failure. These drugs should be offered to all patients although this does not happen consistently for a variety of reasons. Doctors specialising in heart failure may help patients make better informed decisions about treatments and other aspects of care.
The purpose of this research is to explore the diagnosis, management and outcome of patients with heart failure who are referred to the one stop diagnostic heart failure clinic between Jan 2002 and Dec 2007. This study will provide vital information about diagnosis, initiation and titration of evidence based medication in the hospital, their follow in the primary care and subsequent patient outcome in terms of mortality.
Detailed description
Case notes of all the patients who were referred to the one stop diagnostic heart failure clinic during the period (Jan 2002- Dec 2007) will be reviewed and subjects who were found to have signs and symptoms of the Heart failure will be identified.
This cohort of patients will be further analysed and divided on the basis of Echocardiography (special scan of the heart that looks at the contraction, relaxation, and the flow of blood in the heart chambers) results into two groups.
- Those who have impaired contraction (systolic) function of there Left ventricle (left side chamber of the heart)
- Those who have normal contraction (systolic) function of the left ventricle.
Case notes of these patients will then be studied in detail with regards to their initial presentation, clinical examination, Electrocardiogram (electrical tracing of the heart) and chest X ray (picture of the heart and lungs) report.
These will be co-related with the findings and report of the Echocardiogram.
Once the diagnosis is established, uptake of evidence based medications (beta blockers, ACE inhibitors, spironolactone) and their titration up to the target dose at subsequent follow up visits in the heart failure clinic will be examined.
- Phase 2 (General practice/ surgery phase)
This part of the study will be conducted at the GP surgery of the identified patient. This will involve accessing the data held at the GP practice with regards to
- Was heart failure treatment continued after discharge from the hospital clinic?
- If medications continued then for how long?
- If medications discontinued then why and by whom (Hospital/GP)?
- Current medications and the doses
- Admissions to the hospital if any?
- Any other co morbidities developed since discharge for the HF clinic?
- Outcome in terms of mortality
- The cause of death as specified on the death certificate
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| systolic dysfunction | – | –patients having left ventricular systolic dysfunction on echocardiography |
| distolic heart failure | – | –patients with clinical heart failure and preserved LV systolic dysfunction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary care one stop diagnostic heart failure clinic
Key inclusion criteria (1 listed)
- 18 years and over attending heart failure clinic between 01/01/2002- 31/12/07
Key exclusion criteria (2 listed)
- less than 18 years.
- Pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All Cause Mortality
Time frame: Patients would be followed up for average of 7 years
2 secondary outcomes
Cardiovascular Mortality
Time frame: Patients would be followed up for average of 7years
Admission to Hospital for Any Cause
Time frame: During the follow up period of 7 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Rajender Singh, MD principal investigator
county durham and darlington NHS trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by County Durham and Darlington NHS Foundation Trust at 1 site in United Kingdom.
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 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 14 Mar 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 14 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
All Cause Mortality (time frame: Patients would be followed up for average of 7 years). 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 14 Mar 2014.