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

May 12, 2016 updated by: I.C. Van Gelder, University Medical Center Groningen

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

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RB
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

chronic heart failure patients with CRT

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sympathetic innervation in patients with chronic heart failure (CHF)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Isabelle C. Van Gelder, Prof, University Medical Center Groningen, departmen cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

December 4, 2007

First Posted (Estimate)

December 5, 2007

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16716

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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