Clinical trial NCT01013883: The Darlington Retrospective Outpatient Study
Official title: Long Term Outcomes in Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: systolic dysfunction
diastolic dysfunction
mortality
treatment
heart rate
Lead sponsor: County Durham and Darlington NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Durham
First posted: 2009-11-16
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Secondary care one stop diagnostic heart failure clinic

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

Eligibility 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

Primary outcomes:
measure: All Cause Mortality
timeFrame: Patients would be followed up for average of 7 years
Secondary outcomes:
measure: Cardiovascular Mortality
timeFrame: Patients would be followed up for average of 7years
measure: Admission to Hospital for Any Cause
timeFrame: During the follow up period of 7 years
Other outcomes:
Locations:
city: Darlington
country: United Kingdom
facility: Darlington Memorial Hospital
state: Durham
Study officials:
affiliation: county durham and darlington NHS trust
name: Rajender Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: