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Medtronic South Asian Systolic Heart Failure Registry (SASHFR)

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ClinicalTrials.gov Identifier: NCT01434615
Recruitment Status : Completed
First Posted : September 15, 2011
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
The purpose of this study is to (a) characterize the current management of patients with systolic heart failure (HF) in South Asia following an educational intervention of current guidelines and delivery of disease management tools and (b) to characterize the effect of current therapy on clinical outcomes in patients managed by tertiary care centers across South Asia. Current therapy includes characterization of the post market performance of any market released Medtronic cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy plus implantable cardiac defibrillator (CRT-D) system for cardiac resynchronization therapy (CRT).

Condition or disease Intervention/treatment Phase
Heart Failure Device: CRT Other: No-CRT Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 502 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: SASHFR (South Asian Systolic Heart Failure Registry) : A Multi-center, Nonrandomized, Prospective Study to Collect Data Pertaining to the Demographic and Cardiovascular Profiles, Management Strategies and Clinical Outcomes of HF Patients.
Actual Study Start Date : October 2008
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: No-CRT
Patients who meet CRT device implantation guidelines (i.e., meet CRT indication and on optimal medical therapy) but who do not get a CRT-P or CRT-D device implanted
Other: No-CRT
Patients who meet CRT device implantation guidelines (i.e., meet CRT indication and on optimal medical therapy) but who do not get a CRT-P or CRT-D device implanted
Experimental: CRT
Patients who meet CRT device implantation guidelines (i.e., meet CRT indication and on optimal medical therapy) and receive CRT-P or CRT-D device
Device: CRT
Patients who meet CRT device implantation guidelines (i.e., meet CRT indication and on optimal medical therapy) and receive CRT-P or CRT-D device



Primary Outcome Measures :
  1. Clinical Composite score [ Time Frame: 2 years ]
    1. To characterize the long term outcomes (clinical composite score as improved, unchanged or worsened) of patients who meet CRT implant guidelines and (a) receive CRT implant or (b) do not receive the CRT implant.


Secondary Outcome Measures :
  1. Demographics [ Time Frame: 2 years FU ]
    To determine the demographics of HF patients in the registry including LVEF and NYHA Classification.

  2. Profile of patients with positive response to CRT [ Time Frame: 2 years ]
    To characterize the profile of patients with a positive response to CRT. e.g Baseline LVEF



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has signed and dated study informed consent. Patients having moderate to severe heart failure (NYHA Class III or IV) EF < 35% as measured by echo, MUGA, contrast ventriculogram or MRI. QRS duration > 120 ms.

Exclusion Criteria:

Patient has life expectancy of less than 12 months due to medical conditions other than HF.

  • Patient has experienced unstable angina, acute myocardial infarction (MI), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months.
  • Patient is known to have chronic permanent atrial arrhythmias (i.e., cases of long-standing atrial fibrillation of greater than 1 year, including those in which cardioversion has not been indicated or attempted).
  • Patient is enrolled in any concurrent study that would confound the results of this study.
  • Patient is pregnant or breastfeeding.
  • Patient has a CRT device implanted previously.
  • Patient has had a heart transplant.

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): NCT01434615


Locations
India
Care Hospital
Hyderabad, Andhra Pradesh, India, 500 034
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Medtronic
Investigators
Principal Investigator: C Narasimhan Care Hospital, Hyderabd-India

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01434615     History of Changes
Other Study ID Numbers: SASHFR
CTRI/2008/091/000203 ( Registry Identifier: Clinical Trials Registry - India )
First Posted: September 15, 2011    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Cardiac Resynchronization Therapy
Moderate to advanced
patients
current consensus guidelines

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases