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

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087670
• Other study ID #: GrupoRS0002
• Status: Completed
• Phase: N/A
• First received: March 12, 2014
• Last updated: February 9, 2016
• Start date: March 2005
• Est. completion date: January 2008

Study information

• Verified date: February 2016
• Source: Grupo Rehabilitacion en Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Other:
• controlled, supervised exercise protocol
exercise program within a cardiac rehabilitation program
• exercise protocol no supervised
Exercise program at the community

Locations

Country	Name	City	State
Colombia	Universidad de Antioquia	Medellín	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
Grupo Rehabilitacion en Salud	Clinica Las Americas

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natriuretic Brain Pro-peptid		8 weeks	Yes
Secondary	Oxygen Consumption		8 weeks	Yes