Trial Outcomes & Findings for Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction (NCT NCT00755131)

Results Overview

High mobility group box-1 (HMGB1) is a ubiquitous nuclear protein, constitutively expressed in quiescent cells, where it is involved in several cellular functions, including determination of nucleosomal structure and stability, and binding of transcription factors to DNA sequences. HMGB1 has been recently recognized as a critical mediator of inflammatory processes: the passive release of this protein from necrotic or damaged cells represents an effective stimulus triggering the inflammatory response.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

baseline and 6-month follow-up

Results posted on

2010-02-02

Participant Flow

This study was a single-center, randomized, controlled study carried out from October 2008 to January 2009 at the Department of Clinical Medicine, Cardiovascular and Immunological Sciences, University of Naples "Federico II".

Participant milestones

Participant milestones
Measure	Exercise Training Group Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program	Control Group Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
Overall Study STARTED	37	38
Overall Study COMPLETED	37	38
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise Training Group n=37 Participants Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program	Control Group n=38 Participants Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.	Total n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age Continuous	60.8 years STANDARD_DEVIATION 7.0 • n=5 Participants	59.5 years STANDARD_DEVIATION 7.7 • n=7 Participants	60.4 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	32 Participants n=7 Participants	60 Participants n=5 Participants
Region of Enrollment Italy	37 participants n=5 Participants	38 participants n=7 Participants	75 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6-month follow-up

High mobility group box-1 (HMGB1) is a ubiquitous nuclear protein, constitutively expressed in quiescent cells, where it is involved in several cellular functions, including determination of nucleosomal structure and stability, and binding of transcription factors to DNA sequences. HMGB1 has been recently recognized as a critical mediator of inflammatory processes: the passive release of this protein from necrotic or damaged cells represents an effective stimulus triggering the inflammatory response.

Outcome measures

Outcome measures
Measure	Exercise Training Group n=37 Participants Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program	Control Group n=38 Participants Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months Baseline	27.6 ng/ml Standard Deviation 27.8	24.5 ng/ml Standard Deviation 18.6
High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months 6 months	11.7 ng/ml Standard Deviation 7.0	20.5 ng/ml Standard Deviation 15.6

SECONDARY outcome

Timeframe: Baseline and 6-month follow-up

Population: intention to treat (ITT) analysis

Oxygen consumption at peak exercise stress testing (VO2peak) was obtained breath-by-breath with use of a computerized metabolic cart. VO2peak was recorded as the mean value of VO2 during the last 20 s of the test and expressed in millilitres per kilogram per minute.

Outcome measures

Outcome measures
Measure	Exercise Training Group n=37 Participants Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program	Control Group n=38 Participants Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months baseline	16.4 ml/kg/min Standard Deviation 1.5	16.7 ml/kg/min Standard Deviation 2.2
Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months 6 months	21.0 ml/kg/min Standard Deviation 2.4	16.3 ml/kg/min Standard Deviation 1.8

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 6 month follow-up

The autonomic nervous system (ANS) is the part of the peripheral nervous system that acts as a control system functioning largely below the level of consciousness, and controls visceral functions. It is subdivided into two subsystems: the parasympathetic (vagal) and sympathetic nervous system. Sympatho-vagal imbalance is evaluated by post-exercise Heart Rate Recovery (HRR), defined as the fall in heart rate during the first minute after exercise (beats/min). HRR is a marker of vagal tone which is a powerful predictor of all-cause mortality in patients with coronary artery disease.

Outcome measures

Outcome measures
Measure	Exercise Training Group n=37 Participants Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program	Control Group n=38 Participants Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
Heart Rate Recovery at Baseline and 6 Months baseline	13.4 beats/min Standard Deviation 1.7	13.8 beats/min Standard Deviation 2.7
Heart Rate Recovery at Baseline and 6 Months 6 months	19.7 beats/min Standard Deviation 3.4	12.4 beats/min Standard Deviation 2.5

Adverse Events

Exercise Training Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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

Prof. Carlo Vigorito, Director Cardiac Rehabilitation Unit, Federico II University

University of Naples Federico II

Phone: +39081746

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place