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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00567645
First Posted: December 5, 2007
Last Update Posted: May 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
I.C. Van Gelder, University Medical Center Groningen
  Purpose
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
Sympathetic Innervation Chronic Heart Failure

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by I.C. Van Gelder, University Medical Center Groningen:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: July 2007
  Eligibility

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
Criteria

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
  Contacts and Locations
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


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

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 Submitted: December 4, 2007
First Posted: December 5, 2007
Last Update Posted: May 13, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases