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

Cardiac Failure Clinical Trial

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Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524574
• Other study ID #: 09-089
• Status: Completed
• Phase: N/A
• First received: August 6, 2015
• Last updated: March 7, 2016
• Start date: September 2010
• Est. completion date: November 2015

Study information

• Verified date: March 2016
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Failure
• Heart Failure

Intervention

Procedure:
• cardiac Rehabilitation

Other:
• Tomography Positron Emission

Locations

Country	Name	City	State
France	Service de Cardiologie	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of myocardial blood flow during the cold test		change over baseline and after 3 month	No