Trial Outcomes & Findings for Heart Failure Study: The Atlanta Cardiomyopathy Consortium (NCT NCT00599014)

Results Overview

Recruitment status

COMPLETED

Target enrollment

335 participants

Primary outcome timeframe

5 years

Results posted on

2015-11-02

Participant Flow

All participants were stable patients with heart failure. They were recruited during one of their visits to heart failure clinics. The recruitment period started in November 2007 until December 2010. This was an observational study with no interventions.

All patients willing to participate to the study were enrolled. Because this was an observational study, no patients with heart failure (ischemic and non-ischemic) were excluded from participation. Only patients with congenital and infiltrated etiologies were not eligible for the study.

Participant milestones

Participant milestones
Measure	Patients With Heart Failure All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
Overall Study STARTED	335
Overall Study COMPLETED	335
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Heart Failure Study: The Atlanta Cardiomyopathy Consortium

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Heart Failure n=335 Participants All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	300 Participants n=5 Participants
Age, Categorical >=65 years	35 Participants n=5 Participants
Age, Continuous	57.3 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	134 Participants n=5 Participants
Sex: Female, Male Male	201 Participants n=5 Participants
Region of Enrollment United States	335 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Patients With Heart Failure n=335 Participants All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
Death, Heart Transplant, Left Ventricular Assist Device Implantation	35 participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Patients With Heart Failure n=335 Participants All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
Hospitalization	84 participants

Adverse Events

Patients With 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. Javed Butler

Emory University

Phone: 404-778-5136

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place