Trial Outcomes & Findings for Natriuretic Brain Pro-peptid Changes in Patients With Chronic Heart Failure Within a Cardiac Rehabilitation Program (NCT NCT02087670)

NCT ID: NCT02087670

Last Updated: 2016-03-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2016-03-10

Participant Flow

Outpatient with heart failure were recruited since March 2005 to January 2008.

Participant milestones

Measure	Controlled, Supervised Exercise Protocol controlled, supervised exercise protocol within a cardiac rehabilitation program controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program	Community Based Exercise educational program and not supervises exercise program
Overall Study STARTED	20	22
Overall Study COMPLETED	17	20
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Controlled, Supervised Exercise Protocol controlled, supervised exercise protocol within a cardiac rehabilitation program controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program	Community Based Exercise educational program and not supervises exercise program
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Natriuretic Brain Pro-peptid Changes in Patients With Chronic Heart Failure Within a Cardiac Rehabilitation Program

Baseline characteristics by cohort

Measure	Controlled, Supervised Exercise Protocol n=20 Participants controlled, supervised exercise protocol within a cardiac rehabilitation program controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program	Community Based Exercise n=22 Participants educational program and not supervises exercise program	Total n=42 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	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 14 • n=5 Participants	55 years STANDARD_DEVIATION 13 • n=7 Participants	55 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment Colombia	20 participants n=5 Participants	22 participants n=7 Participants	42 participants n=5 Participants
Natriuretic Brain pro-peptide	429 pg/ml n=5 Participants	278 pg/ml n=7 Participants	386 pg/ml n=5 Participants
Oxygen Consumption	832 ml/min STANDARD_DEVIATION 228 • n=5 Participants	811 ml/min STANDARD_DEVIATION 229 • n=7 Participants	821 ml/min STANDARD_DEVIATION 226 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Measure	Controlled, Supervised Exercise Protocol n=19 Participants controlled, supervised exercise protocol within a cardiac rehabilitation program controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program	Community Based Exercise n=22 Participants educational program and not supervises exercise program
Natriuretic Brain Pro-peptid	312 pg/ml Interval 24.0 to 2312.0	200 pg/ml Interval 14.0 to 3481.0

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Measure	Controlled, Supervised Exercise Protocol n=17 Participants controlled, supervised exercise protocol within a cardiac rehabilitation program controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program	Community Based Exercise n=20 Participants educational program and not supervises exercise program
Oxygen Consumption	831 ml/min Standard Deviation 250	919 ml/min Standard Deviation 298

Adverse Events

Controlled, Supervised Exercise Protocol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Community Based Exercise

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

Jesus Alberto Plata Contreras

Universidad de Antioquia

Phone: 5742196478

Email: rehabilitacionsalud@siu.udea.edu.co

Results disclosure agreements

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