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Tomography Positron Emission Assessment of the Impact of Cardiac Rehabilitation on Coronary Endothelial Function in Cardiac Failure (TEP-READ)

Primary Purpose

Cardiac Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cardiac Rehabilitation
Tomography Positron Emission
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Service de Cardiologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cardiac Rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

Rate of myocardial blood flow during the cold test

Secondary Outcome Measures

Full Information

First Posted
August 6, 2015
Last Updated
March 7, 2016
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02524574
Brief Title
Tomography Positron Emission Assessment of the Impact of Cardiac Rehabilitation on Coronary Endothelial Function in Cardiac Failure
Acronym
TEP-READ
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cardiac Rehabilitation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
cardiac Rehabilitation
Intervention Type
Other
Intervention Name(s)
Tomography Positron Emission
Primary Outcome Measure Information:
Title
Rate of myocardial blood flow during the cold test
Time Frame
change over baseline and after 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Service de Cardiologie
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25525058
Citation
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.
Results Reference
result
PubMed Identifier
26280980
Citation
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.
Results Reference
result

Learn more about this trial

Tomography Positron Emission Assessment of the Impact of Cardiac Rehabilitation on Coronary Endothelial Function in Cardiac Failure

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