NCT01013883

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
509

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

March 14, 2014

Completed
Last Updated

March 14, 2014

Status Verified

January 1, 2014

Enrollment Period

1.6 years

First QC Date

November 13, 2009

Results QC Date

August 23, 2013

Last Update Submit

January 28, 2014

Conditions

Keywords

systolic dysfunctiondiastolic dysfunctionmortalitytreatmentheart rate

Outcome Measures

Primary Outcomes (1)

  • All Cause Mortality

    Patients would be followed up for average of 7 years

Secondary Outcomes (2)

  • Cardiovascular Mortality

    Patients would be followed up for average of 7years

  • Admission to Hospital for Any Cause

    During the follow up period of 7 years

Study Arms (2)

systolic dysfunction

patients having left ventricular systolic dysfunction on echocardiography

distolic heart failure

patients with clinical heart failure and preserved LV systolic dysfunction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Secondary care one stop diagnostic heart failure clinic

You may qualify if:

  • years and over attending heart failure clinic between 01/01/2002- 31/12/07

You may not qualify if:

  • less than 18 years.
  • Pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Darlington Memorial Hospital

Darlington, Durham, DL3 6HX, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr Rajender singh
Organization
Darlington Memorial Hospital

Study Officials

  • Rajender Singh, MD

    county durham and darlington NHS trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research registrar

Study Record Dates

First Submitted

November 13, 2009

First Posted

November 16, 2009

Study Start

January 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 14, 2014

Results First Posted

March 14, 2014

Record last verified: 2014-01

Locations