Screening for Advanced Heart Failure Treatment (SEE-HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Thoratec Europe Ltd
Sponsor:
Information provided by (Responsible Party):
Thoratec Europe Ltd
ClinicalTrials.gov Identifier:
NCT01626404
First received: June 20, 2012
Last updated: September 29, 2014
Last verified: September 2014
  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: July 2015
Estimated Primary Completion Date: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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         
University Clinical Center Tuebingen Recruiting
Tuebingen, Germany
Contact: David Schibilsky, MD       David.Schibilsky@med.uni-tuebingen.de   
Principal Investigator: David Schibilsky, 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: September 29, 2014
Health Authority: Denmark: ethics review board, Sweden: ethics review board

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 20, 2014