Medtronic South Asian Systolic Heart Failure Registry

Heart Failure Clinical Trial

— SASHFR  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434615
• Other study ID #: SASHFR
• Secondary ID: CTRI/2008/091/00
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2011
• Last updated: December 5, 2017
• Start date: October 2008
• Est. completion date: December 2015

Study information

• Verified date: December 2017
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

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

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

Locations

Country	Name	City	State
India	Care Hospital	Hyderabad	Andhra Pradesh

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure	Medtronic

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Composite score	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.	2 years
Secondary	Demographics	To determine the demographics of HF patients in the registry including LVEF and NYHA Classification.	2 years FU
Secondary	Profile of patients with positive response to CRT	To characterize the profile of patients with a positive response to CRT. e.g Baseline LVEF	2 years