Trial Outcomes & Findings for The Darlington Retrospective Outpatient Study (NCT NCT01013883)

NCT ID: NCT01013883

Last Updated: 2014-03-14

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 509 participants
• Primary outcome timeframe: Patients would be followed up for average of 7 years
• Results posted on: 2014-03-14

Participant Flow

Patients referred to the one stop diagnostic heart failure clinic from Jan 2002 to Dec 2007, were followed up till Aug 2011.

Participant milestones

Measure	Systolic Dysfunction patients having left ventricular systolic dysfunction on echocardiography	Distolic Heart Failure patients with clinical heart failure and preserved LV systolic dysfunction
Overall Study STARTED	270	243
Overall Study COMPLETED	268	241
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Systolic Dysfunction patients having left ventricular systolic dysfunction on echocardiography	Distolic Heart Failure patients with clinical heart failure and preserved LV systolic dysfunction
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

The Darlington Retrospective Outpatient Study

Baseline characteristics by cohort

Measure	Systolic Dysfunction n=268 Participants patients having left ventricular systolic dysfunction on echocardiography	Distolic Heart Failure n=241 Participants patients with clinical heart failure and preserved LV systolic dysfunction	Total n=509 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=93 Participants	21 Participants n=4 Participants	70 Participants n=27 Participants
Age, Categorical >=65 years	219 Participants n=93 Participants	220 Participants n=4 Participants	439 Participants n=27 Participants
Age, Continuous	74 years STANDARD_DEVIATION 10 • n=93 Participants	78 years STANDARD_DEVIATION 8 • n=4 Participants	76 years STANDARD_DEVIATION 10 • n=27 Participants
Sex: Female, Male Female	104 Participants n=93 Participants	157 Participants n=4 Participants	261 Participants n=27 Participants
Sex: Female, Male Male	164 Participants n=93 Participants	84 Participants n=4 Participants	248 Participants n=27 Participants
Region of Enrollment United Kingdom	268 participants n=93 Participants	241 participants n=4 Participants	509 participants n=27 Participants

PRIMARY outcome

Timeframe: Patients would be followed up for average of 7 years

Outcome measures

Measure	Systolic Dysfunction n=268 Participants patients having left ventricular systolic dysfunction on echocardiography	Distolic Heart Failure n=241 Participants patients with clinical heart failure and preserved LV systolic dysfunction
All Cause Mortality	163 participants	118 participants

SECONDARY outcome

Timeframe: Patients would be followed up for average of 7years

Outcome measures

Measure	Systolic Dysfunction n=268 Participants patients having left ventricular systolic dysfunction on echocardiography	Distolic Heart Failure n=241 Participants patients with clinical heart failure and preserved LV systolic dysfunction
Cardiovascular Mortality	113 participants Interval 0.315 to 0.61	51 participants

SECONDARY outcome

Timeframe: During the follow up period of 7 years

Number of patients admitted to the hospital will be recorded

Outcome measures

Measure	Systolic Dysfunction n=268 Participants patients having left ventricular systolic dysfunction on echocardiography	Distolic Heart Failure n=241 Participants patients with clinical heart failure and preserved LV systolic dysfunction
Admission to Hospital for Any Cause	189 participants Interval 0.292 to 0.519	158 participants Interval 0.292 to 0.519

Adverse Events

Systolic Dysfunction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Distolic Heart Failure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Rajender singh

Darlington Memorial Hospital

Phone: 01325380100

Email: drrsdogra@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place