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

This study is currently recruiting participants.
Verified June 2012 by University Medical Centre Groningen
Sponsor:
Information provided by (Responsible Party):
I.C. Van Gelder, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00567645
First received: December 4, 2007
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  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:

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

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • sympathetic innervation in patients with chronic heart failure (CHF) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: July 2007
Estimated Study Completion Date: December 2012
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567645

Contacts
Contact: Isabelle C Van Gelder, Prof 050-3612355 i.c.van.gelder@thorax.umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: I.C. van Gelder , Prof     050-3612355     i.c.van.Gelder@thorax.umcg.nl    
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Isabelle C. Van Gelder, Prof University Medical Center Groningen, departmen cardiology
  More Information

No publications provided

Responsible Party: I.C. Van Gelder, Prof.dr., University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT00567645     History of Changes
Other Study ID Numbers: 16716
Study First Received: December 4, 2007
Last Updated: June 18, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013