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.

Study Overview

• Status: Completed
• Conditions: Heart Failure

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

• Study Type: Observational
• Enrollment (Actual): 509

Contacts and Locations

Study Locations

• United Kingdom
  • Durham
    • Darlington, Durham, United Kingdom, DL3 6HX
      • Darlington Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Secondary care one stop diagnostic heart failure clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All Cause Mortality	Patients would be followed up for average of 7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Mortality		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	During the follow up period of 7 years

Collaborators and Investigators

• Sponsor: County Durham and Darlington NHS Foundation Trust
• Collaborators: University of Durham
• Investigators: Principal Investigator: Rajender Singh, MD, county durham and darlington NHS trust

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: November 13, 2009
• First Submitted That Met QC Criteria: November 13, 2009
• First Posted (Estimate): November 16, 2009

Study Record Updates

• Last Update Posted (Estimate): March 14, 2014
• Last Update Submitted That Met QC Criteria: January 28, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: treatment; mortality; diastolic dysfunction; heart rate; systolic dysfunction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: RajPh.D2066