Sympathetic Innervation of the Heart and Cardiac Resynchronization Therapy(CRT)

Chronic Heart Failure Clinical Trial

— PET-CRT  

Official title:

Identification of the Role of Sympathetic Innervation in Heart Failure Patients Treated With Cardiac Resynchronization Therapy. A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00567645
• Other study ID #: 16716
• Status: Withdrawn
• Phase: N/A
• First received: December 4, 2007
• Last updated: May 12, 2016
• Start date: July 2007

Study information

• Verified date: May 2016
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess whether baseline sympathetic innervation in patients with chronic heart failure (CHF) is predictive for response to cardiac resynchronization therapy (CRT). And to assess whether response to CRT coincides with restoration of regional sympathetic innervation.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Indication for CRT

• Stable optimal medication

• Non ischemic cardiomyopathy

Exclusion Criteria:

• Age less then 18 years

• Previous CRT

• Clinically relevant valvular heart disease or coronary artery disease

• Acute or chronic infection

• Untreated clinical hypo- or hyperthyroidism or < 3 months euthyroidism

• Uncontrolled hypertension, defined as a systolic blood pressure > 160 mm Hg and/or a diastolic blood pressure > 95 mm Hg

• A concurrent medical condition (i.e. alcohol or drug abuse or a severe progressive extra cardiac disease or M. Parkinson) or is unlikely to comply with the protocol

• Participation to a previous protocol involving radioactivity in the past year

• Pregnancy

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Sympathetic Innervation

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sympathetic innervation in patients with chronic heart failure (CHF)		6 months	No
Secondary	NYHA class Echocardiographic parameters: LVEDD, LVESD, LVEF, LVESV,IVMD, and septal to lateral delay Hospitalization for heart failure Maximal oxygen consumption NT pro-BNP changes		6 months	No