Heart FailurePhase 4SASHFRNCT01434615
Medtronic South Asian Systolic Heart Failure Registry
A Phase 4 study testing CRT and No-CRT in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in India.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- CRT and No-CRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2008to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
- Conditions
- Heart Failure
- Being tested
- CRT, No-CRT
- Keywords
- Cardiac Resynchronization Therapy, Moderate to advanced, patients, current consensus guidelines
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRTDevice
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
No-CRTOther
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
| Study group | Role | What they receive |
|---|---|---|
| No-CRT | Experimental | 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 Receives: Other: No-CRT |
| CRT | Experimental | 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 Receives: Device: CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Composite score
- 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.
Measured: 2 years
Secondary outcomes (2)
Demographics
To determine the demographics of HF patients in the registry including LVEF and NYHA Classification.
Measured: 2 years FU
Profile of patients with positive response to CRT
To characterize the profile of patients with a positive response to CRT. e.g Baseline LVEF
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startOct 2008
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- C Narasimhan, Principal investigator, Care Hospital, Hyderabd-India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434615
- Sponsor's protocol ID
- SASHFR
- Other IDs
- CTRI/2008/091/000203
- Acronym
- SASHFR
- Status last verified
- Dec 2017
- First submitted
- 13 Sep 2011
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01434615
- Acronym / sponsor ID
- SASHFR / SASHFR
- Conditions
- Heart Failure
- Keywords
- Cardiac Resynchronization Therapy, Moderate to advanced, patients, current consensus guidelines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Oct 2008 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-CRT | Experimental | Other: No-CRTPatients 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 |
| CRT | Experimental | Device: CRTPatients who meet CRT device implantation guidelines (i.e., meet CRT indication and on optimal medical therapy) and receive CRT-P or CRT-D device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRTPatients 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 |
| No-CRTPatients 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 |
Primary outcome
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.
2 secondary outcomes
Demographics
Time frame: 2 years FU
Profile of patients with positive response to CRT
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C Narasimhan principal investigator
Care Hospital, Hyderabd-India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CRT and No-CRT in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Composite score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.