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Completed

NCT Number: NCT01013883

The Darlington Retrospective Outpatient Study

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Darlington Memorial Hospital

Darlington, Durham, DL3 6HX, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. All Cause Mortality

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

Secondary outcomes

  1. Cardiovascular Mortality

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

  2. Admission to Hospital for Any Cause

    Time frame: During the follow up period of 7 years

    Number of patients admitted to the hospital will be recorded

Sponsors and collaborators

Lead sponsor

County Durham and Darlington NHS Foundation Trust

Other Gov

Collaborators

  • University of Durham

Registry information

Official study title

Long Term Outcomes in Patients With Heart Failure

Acronym: DROPSY

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 16, 2009
Registry last updated
Mar 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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