- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01013883
The Darlington Retrospective Outpatient Study (DROPSY)
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
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
- 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
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Durham
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Darlington, Durham, Storbritannia, DL3 6HX
- Darlington Memorial Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
systolic dysfunction
patients having left ventricular systolic dysfunction on echocardiography
|
distolic heart failure
patients with clinical heart failure and preserved LV systolic dysfunction
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
All Cause Mortality
Tidsramme: Patients would be followed up for average of 7 years
|
Patients would be followed up for average of 7 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Cardiovascular Mortality
Tidsramme: Patients would be followed up for average of 7years
|
Patients would be followed up for average of 7years
|
|
Admission to Hospital for Any Cause
Tidsramme: During the follow up period of 7 years
|
Number of patients admitted to the hospital will be recorded
|
During the follow up period of 7 years
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Rajender Singh, MD, county durham and darlington NHS trust
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RajPh.D2066
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