NCT02524574

Brief Summary

In patients with heart failure, the drive to the effort has demonstrated its safety and its interest. Patients with heart failure, endothelium-dependent peripheral vasodilatation is impaired by decreased activity of endothelial NO synthase. The rehabilitation training significantly improves peripheral endothelial function, and this improvement is correlated to the increase in exercise capacity. The impact on coronary endothelial function remains poorly documented, especially in non-ischemic dilated heart disease. The main objective of this study is to investigate the effectiveness of cardiac rehabilitation on the restoration of coronary endothelial function in cardiac failure patient evaluated with Tomography Positron Emission 15O-H2O.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

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

September 1, 2010

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

5.2 years

First QC Date

August 6, 2015

Last Update Submit

March 7, 2016

Conditions

Cardiac Failure

Outcome Measures

Primary Outcomes (1)

  • Rate of myocardial blood flow during the cold test

    change over baseline and after 3 month

Study Arms (1)

cardiac Rehabilitation

EXPERIMENTAL
Procedure: cardiac RehabilitationOther: Tomography Positron Emission

Interventions

cardiac RehabilitationPROCEDURE
cardiac Rehabilitation
Tomography Positron EmissionOTHER
cardiac Rehabilitation

Eligibility Criteria

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

You may qualify if:

  • Patients with heart failure with nonischemic dilated cardiomyopathy
  • Class II-III NYHA (New York Heart Association)
  • Having no contra-indication to the effort
  • Fraction Ejection ≤ 40%
  • patient who will have cardiac rehabilitation
  • Age over 18 years
  • informed consent signed
  • patient with a social security scheme

You may not qualify if:

  • Hypertension\> 160/90 mmHg
  • High cholesterol level \> 6.0 mmol / l
  • Diabetes known and treated
  • Active smoking
  • Valvular heart disease, congenital or ischemic
  • Pregnant or breastfeeding women
  • Age \<18 years
  • Major Adult guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Cardiologie

Caen, 14000, France

Location

Related Publications (2)

  • Legallois D, Belin A, Nesterov SV, Milliez P, Parienti JJ, Knuuti J, Abbas A, Tirel O, Agostini D, Manrique A. Cardiac rehabilitation improves coronary endothelial function in patients with heart failure due to dilated cardiomyopathy: A positron emission tomography study. Eur J Prev Cardiol. 2016 Jan;23(2):129-36. doi: 10.1177/2047487314565739. Epub 2014 Dec 18.

    PMID: 25525058RESULT

  • Tuffier S, Legallois D, Belin A, Joubert M, Bailliez A, Redonnet M, Agostini D, Manrique A. Assessment of endothelial function and myocardial flow reserve using (15)O-water PET without attenuation correction. Eur J Nucl Med Mol Imaging. 2016 Feb;43(2):288-295. doi: 10.1007/s00259-015-3163-x. Epub 2015 Aug 18.

    PMID: 26280980RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac RehabilitationMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 17, 2015

Study Start

September 1, 2010

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

FR(1)