NCT01939795

Brief Summary

The investigators hypothesis that exercise training would potentiate the effects of cardiac resynchronization therapy in heart failure patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

5.7 years

First QC Date

March 27, 2013

Last Update Submit

October 24, 2016

Conditions

Heart Failure

Keywords

cardiac resynchronization therapy (CRT)

Outcome Measures

Primary Outcomes (1)

  • Sympathetic nerve activity

    Sympathetic nerve activity will be assessed by microneurography

    4 months

Secondary Outcomes (5)

  • Peak oxygen consumption

    4 months

  • Quality of life

    4 months

  • Blood inflammatory markers

    4 months

  • skeletal muscle strength

    4 months

  • Muscle Blood Flow

    4 months

Study Arms (3)

Healthy People

NO INTERVENTION

Control group

Untrained CRT

EXPERIMENTAL

Untrained CRT patients

Other: exercise training and/or CRT

Exercise trained + CRT

EXPERIMENTAL

Exercise-trained CRT patients

Other: exercise training and/or CRT

Interventions

exercise training and/or CRTOTHER

Three 40-minute exercise sessions per week on a treadmill for four months

Also known as: Untrained CRT patients, Exercise-trained CRT patients
Exercise trained + CRTUntrained CRT

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • QRS\> 150 ms or 120-150ms associated dyssynchrony
  • The etiology can be idiopathic, ischemic, hypertensive and Chagas' disease
  • Ejection fraction \<35%

You may not qualify if:

  • Patients with pulmonary diseases, neurological diseases, renal, skeletal muscle diseases
  • Patients with contraindications to implant a cardiac pacemaker
  • Pregnancy
  • New York Heart Association functional class IV
  • Atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thais Simoes Nobre Pires Santos

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Carlos E Negrao, Phd

    InCor, HCFMUSP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd student

Study Record Dates

First Submitted

March 27, 2013

First Posted

September 11, 2013

Study Start

January 1, 2009

Primary Completion

September 1, 2014

Study Completion

March 1, 2015

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations

BR(1)