The Darlington Retrospective Outpatient Study (DROPSY)

This study has been completed.
Sponsor:
Collaborator:
University of Durham
Information provided by (Responsible Party):
Rajender Singh, County Durham and Darlington NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01013883
First received: November 13, 2009
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long Term Outcomes in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by County Durham and Darlington NHS Foundation Trust:

Primary Outcome Measures:
  • All Cause Mortality [ Time Frame: Patients would be followed up for average of 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular Mortality [ Time Frame: Patients would be followed up for average of 7years ] [ Designated as safety issue: No ]
  • Admission to Hospital for Any Cause [ Time Frame: During the follow up period of 7 years ] [ Designated as safety issue: No ]
    Number of patients admitted to the hospital will be recorded


Enrollment: 509
Study Start Date: January 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
systolic dysfunction
patients having left ventricular systolic dysfunction on echocardiography
distolic heart failure
patients with clinical heart failure and preserved LV systolic dysfunction

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Secondary care one stop diagnostic heart failure clinic

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013883

Locations
United Kingdom
Darlington Memorial Hospital
Darlington, Durham, United Kingdom, DL3 6HX
Sponsors and Collaborators
County Durham and Darlington NHS Foundation Trust
University of Durham
Investigators
Principal Investigator: Rajender Singh, MD county durham and darlington NHS trust
  More Information

No publications provided

Responsible Party: Rajender Singh, Research registrar, County Durham and Darlington NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01013883     History of Changes
Other Study ID Numbers: RajPh.D2066
Study First Received: November 13, 2009
Results First Received: August 23, 2013
Last Updated: January 28, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by County Durham and Darlington NHS Foundation Trust:
systolic dysfunction
diastolic dysfunction
mortality
treatment
heart rate

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014