Trial Outcomes & Findings for Oxidative Stress Markers and Cardiac Resynchronization Therapy (CRT) Outcomes (NCT NCT01151553)

NCT ID: NCT01151553

Last Updated: 2013-09-19

Results Overview

Patient has a weak heart and scheduled to have CRT placed in the next month. The study is to evaluate blood markers which may predict which patients who receive CRT will improve

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: One year
• Results posted on: 2013-09-19

Participant Flow

Participant milestones

Measure	Patients With CHF With CRT Therapy Patients with CHF with CRT Therapy CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oxidative Stress Markers and Cardiac Resynchronization Therapy (CRT) Outcomes

Baseline characteristics by cohort

Measure	Patients With CHF With CRT Therapy n=5 Participants Patients with CHF with CRT Therapy CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	62.8 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: Early termination leading to small numbers of subjects; lost funding and staff, no data collected/processed.

Patient has a weak heart and scheduled to have CRT placed in the next month. The study is to evaluate blood markers which may predict which patients who receive CRT will improve

Outcome measures

Outcome data not reported

Adverse Events

Patients With CHF With CRT Therapy

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. Heather Bloom

Emory University

Phone: 404-321-6111

Email: heather.bloom@emory.edu

Results disclosure agreements

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