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The Darlington Retrospective Outpatient Study

Long Term Outcomes in Patients With Heart Failure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01013883
Acronym
DROPSY
Enrollment
509
Registered
2009-11-16
Start date
2010-01-31
Completion date
2011-08-31
Last updated
2014-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

systolic dysfunction, diastolic dysfunction, mortality, treatment, heart rate

Brief 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. 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. 1. Those who have impaired contraction (systolic) function of there Left ventricle (left side chamber of the heart) 2. 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. B) 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 1. Was heart failure treatment continued after discharge from the hospital clinic? 2. If medications continued then for how long? 3. If medications discontinued then why and by whom (Hospital/GP)? 4. Current medications and the doses 5. Admissions to the hospital if any? 6. Any other co morbidities developed since discharge for the HF clinic? 7. Outcome in terms of mortality 8. The cause of death as specified on the death certificate

Interventions

None listed

Sponsors

University of Durham
CollaboratorOTHER
County Durham and Darlington NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years and over attending heart failure clinic between 01/01/2002- 31/12/07

Exclusion criteria

* less than 18 years. Pregnant females

Design outcomes

Primary

MeasureTime frame
All Cause MortalityPatients would be followed up for average of 7 years

Secondary

MeasureTime frameDescription
Cardiovascular MortalityPatients would be followed up for average of 7years
Admission to Hospital for Any CauseDuring the follow up period of 7 yearsNumber of patients admitted to the hospital will be recorded

Countries

United Kingdom

Participant flow

Recruitment details

Patients referred to the one stop diagnostic heart failure clinic from Jan 2002 to Dec 2007, were followed up till Aug 2011.

Participants by arm

ArmCount
Systolic Dysfunction
patients having left ventricular systolic dysfunction on echocardiography
268
Distolic Heart Failure
patients with clinical heart failure and preserved LV systolic dysfunction
241
Total509

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up22

Baseline characteristics

CharacteristicDistolic Heart FailureSystolic DysfunctionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
220 Participants219 Participants439 Participants
Age, Categorical
Between 18 and 65 years
21 Participants49 Participants70 Participants
Age, Continuous78 years
STANDARD_DEVIATION 8
74 years
STANDARD_DEVIATION 10
76 years
STANDARD_DEVIATION 10
Region of Enrollment
United Kingdom
241 participants268 participants509 participants
Sex: Female, Male
Female
157 Participants104 Participants261 Participants
Sex: Female, Male
Male
84 Participants164 Participants248 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

All Cause Mortality

Time frame: Patients would be followed up for average of 7 years

ArmMeasureValue (NUMBER)
Systolic DysfunctionAll Cause Mortality163 participants
Distolic Heart FailureAll Cause Mortality118 participants
Secondary

Admission to Hospital for Any Cause

Number of patients admitted to the hospital will be recorded

Time frame: During the follow up period of 7 years

ArmMeasureValue (NUMBER)
Systolic DysfunctionAdmission to Hospital for Any Cause189 participants
Distolic Heart FailureAdmission to Hospital for Any Cause158 participants
Secondary

Cardiovascular Mortality

Time frame: Patients would be followed up for average of 7years

ArmMeasureValue (NUMBER)
Systolic DysfunctionCardiovascular Mortality113 participants
Distolic Heart FailureCardiovascular Mortality51 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026