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

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ClinicalTrials.gov Identifier: NCT00567645
Recruitment Status : Withdrawn
First Posted : December 5, 2007
Last Update Posted : May 13, 2016
Information provided by (Responsible Party):
I.C. Van Gelder, University Medical Center Groningen

Brief 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.

Condition or disease
Sympathetic Innervation Chronic Heart Failure

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Identification of the Role of Sympathetic Innervation in Heart Failure Patients Treated With Cardiac Resynchronization Therapy. A Pilot Study
Study Start Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Primary Outcome Measures :
  1. sympathetic innervation in patients with chronic heart failure (CHF) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
chronic heart failure patients with CRT

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567645

University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
Principal Investigator: Isabelle C. Van Gelder, Prof University Medical Center Groningen, departmen cardiology

Responsible Party: I.C. Van Gelder, Prof.dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT00567645     History of Changes
Other Study ID Numbers: 16716
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases