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

Natriuretic Brain Pro-peptid (Pro-BNP)Changes in Patients With Chronic Heart Failure Enroled in a Controlled, Supervised Exercise Protocol Within a Cardiac Rehabilitation Program

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02087670

Enrollment

Registered

2014-03-14

Start date

2005-03-31

Completion date

2008-01-31

Last updated

2016-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Keywords

chronic heart failure, cardiac rehabilitation, exercise, Natriuretic Brain Pro-peptid

Brief summary

Evaluate pro-BNP levels, oxygen consumption, functional class, and quality of life in patients with chronic heart failure after participating in an exercise program and compare them baseline and 2 months, with another group who underwent an educational program.

Detailed description

Clinical controlled trial with a double blinded with a aleatory number sequence as the randomization method, patients will be assigned to one of two groups, intervention program (supervises exercise program) and control group (community based exercise)

Interventions

OTHERcontrolled, supervised exercise protocol

exercise program within a cardiac rehabilitation program

OTHERexercise protocol no supervised

Exercise program at the community

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients older than 18 years, diagnosed with heart failure (NYHA) II-IV for more than six months

Exclusion criteria

* patients with NYHA functional class I, who had attended a cardiac rehabilitation program previously, patients with decompensated diabetes mellitus, hypertension difficult to control, ischemic heart disease in the last month, prior pulmonary embolism, chronic obstructive pulmonary disease, restrictive lung disease , aortic stenosis, new episode of atrial fibrillation and musculoskeletal diseases that limit the performance of physical activity

Design outcomes

Primary

Measure	Time frame
Natriuretic Brain Pro-peptid	8 weeks

Secondary

Measure	Time frame
Oxygen Consumption	8 weeks

Countries

Colombia

Participant flow

Recruitment details

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

Participants by arm

Arm	Count
Controlled, Supervised Exercise Protocol controlled, supervised exercise protocol within a cardiac rehabilitation program controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program	20
Community Based Exercise educational program and not supervises exercise program	22
Total	42

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	3	2

Baseline characteristics

Characteristic	Controlled, Supervised Exercise Protocol	Community Based Exercise	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	20 Participants	22 Participants	42 Participants
Age, Continuous	57 years STANDARD_DEVIATION 14	55 years STANDARD_DEVIATION 13	55 years STANDARD_DEVIATION 11
Natriuretic Brain pro-peptide	429 pg/ml	278 pg/ml	386 pg/ml
Oxygen Consumption	832 ml/min STANDARD_DEVIATION 228	811 ml/min STANDARD_DEVIATION 229	821 ml/min STANDARD_DEVIATION 226
Region of Enrollment Colombia	20 participants	22 participants	42 participants
Sex: Female, Male Female	10 Participants	11 Participants	21 Participants
Sex: Female, Male Male	10 Participants	11 Participants	21 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 20	0 / 22
serious Total, serious adverse events	0 / 20	0 / 22

Outcome results

Primary