Screening for Advanced Heart Failure Treatment (SEE-HF)

This study is currently recruiting participants.
Verified December 2013 by Thoratec Europe Ltd
Sponsor:
Information provided by (Responsible Party):
Thoratec Europe Ltd
ClinicalTrials.gov Identifier:
NCT01626404
First received: June 20, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients are underserved. The purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with CRT and/or ICD who are candidates for advanced heart failure treatment and obtain insights into patient and physician decisions regarding referral for advanced heart failure therapy.


Condition
Advanced Heart Failure
CRT and/or ICD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Advanced Heart Failure Treatment (SEE-HF)

Resource links provided by NLM:


Further study details as provided by Thoratec Europe Ltd:

Primary Outcome Measures:
  • Proportion of patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Proportion of heart failure patients followed in outpatient clinic that are NYHA III-IV with LVEF </= 40% and a CRT and/or ICD who have an indication without contraindication for heart transplantationi and/or DT LVAD.


Secondary Outcome Measures:
  • Reasons for non-referral [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assess physician's reasons for non-referral of patients for LVAD/transplant evaluation.

  • Patient's reasons [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assess patients reasons for declining LVAD/transplant as a treatment option.

  • Actual and predicted 12 month survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assess the actual and predicted 12 month survival (predicted by VO2, the Heart Failure Survival Score (HFSS) and the Seattle Heart Failure Model (SHFM)).

  • Simple clinical parameters for referral [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Identify simple clinical parameters that can be used by physicians to refer patients for LVAD/transplant evaluation at an optimal time.


Estimated Enrollment: 384
Study Start Date: October 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients enrolled
All patients enrolled in the study

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatients with CRT and/or ICD, EF </= 40% and in NYHA III-IV

Criteria

Inclusion Criteria:

  • CRT and or ICD device in place.
  • NYHA class III - IV heart failure
  • EF </= 40%
  • Patient is an out-patient
  • Patient is on optimal medical management as tolerated and as defined by primary care physician.
  • Patient has signed an informed consent for data collection.

Exclusion Criteria:

  • Age <18 years or >80 years
  • CRT device that has been implanted < 3 months prior to enrollment
  • Coronary revascularization within 3 months prior to enrollment
  • Patient only has ICD but has CRT planned
  • Non-cardiac disease resulting in life expectancy < 2 yrs
  • Patient is hospitalized or will be hospitalized at this time
  • Known diagnosis of dementia
  • Patient is currently on dialysis
  • Oxygen dependent lung disease
  • Previously or currently treated with LVAD or heart transplantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626404

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Finn Gustafsson, MD       finng@dadlnet.dk   
Principal Investigator: Finn Gustafsson, MD         
France
CHU of Nantes Recruiting
Nantes, France
Contact: Jean-Noel Trochu, MD       jeannoel.trochu@chu-nantes.fr   
Principal Investigator: Jean-Noel Trochu, MD         
Germany
Hannover Medical Center Recruiting
Hannover, Germany
Contact: Jan Schmitto, MD       schmitto.jan@mh-hannover.de   
Principal Investigator: Jan Schmitto, MD         
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: Kadir Caliskan, MD       k.caliskan@erasmusmc.nl   
Principal Investigator: Kadir Caliskan, MD         
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Lars Lund, MD       lars.lund@karolinska.se   
Principal Investigator: Lars Lund, MD         
United Kingdom
University Hospital of South Manchester NHS Trust Recruiting
Manchester, United Kingdom
Contact: Steve Shaw, MD       steven.shaw@uhsm.nhs.uk   
Principal Investigator: Steve Shaw, MD         
Sponsors and Collaborators
Thoratec Europe Ltd
Investigators
Study Director: Laura Damme, BSN, MPH Thoratec Europe Limited
  More Information

No publications provided

Responsible Party: Thoratec Europe Ltd
ClinicalTrials.gov Identifier: NCT01626404     History of Changes
Other Study ID Numbers: TC-060112
Study First Received: June 20, 2012
Last Updated: December 19, 2013
Health Authority: Denmark: ethics review board, Sweden: ethics review board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014