Heart Failure Clinical Trial
Official title:
Manipal Heart Failure Registry (MHFR): A Long Term, Prospective and Descriptive Study of Heart Failure in a Tertiary Care Hospital in South India
Burden of HF in India is approximate 2-5 million patients with an estimated prevalence of
2-3/1000 population. HF is responsible for approx1.8 million admissions annually in India.
Very few studies are there in India which shows the detailed documentation of HF.
Manipal Heart failure Registry (MHFR) is an institutional level Heart Failure disease
registry. In MHFR the investigator will document the detailed information about heart
failure patients admitted or referred to Department of Cardiology, Kasturba Medical College,
a constituent college and teaching hospital of Manipal University.
MHFR will include cohorts of patients with acute heart failure (AHF), with the intention of
implementing a long-term follow-up, the use of health economic assessment to evaluate the
degree of resource utilization; and quantifying the burden on quality of life for patients.
Utilization of drug in HF patients will be evaluated as a part of this study to prevent the
use of inappropriate drug therapy and to improve overall drug effectiveness and outcomes.
Hence the protocol sought to identify the characteristics and long-term outcomes of Indian
patients with acute heart failure admitted in an Indian tertiary care center in South India.
There are no risks to patients participating in the registry study, as standard of care
quality will not be affected. It is unlikely that there will be any direct benefit as a
result of participation in the HF-disease registry. However, the information contained
within this non-interventional registry study will be used for research studies directed at
improving the knowledge and treatment of acute heart failure as well as improving patients
treatment in the future.
The potential impact of proposed research (Manipal Heart Failure Registry) is envisioned to
be four-fold:
1. to enable a broad overview of the routine medical practices for HF treatment;
2. to assess the healthcare resource utilization and drug utilization review for heart
failure patients
3. to assess the burden of disease (mortality, re-hospitalization) in the long term; and
4. to provide a novel overview of the impact of HF syndrome on quality of life as well as
health economics.
RESEARCH GAPS IDENTIFIED:
Only a couple of registry studies in India have followed patients for not more than one year
and therefore long-term data on disease management and healthcare resource utilization and
health economics has never addressed adequately. Typically, these studies have focused
primarily upon inpatient HF clinical profiles, where detailed long-term documentation of
cardiac function, treatment patterns, and outcomes is lacking.
HYPOTHESES:
Long term follow up of heart failure patients can identify the disease characteristics,
clinical outcomes and help in the development of a disease progression model, thereby
eventually improving the practice standards. Proper utilization of healthcare resources
decrease in-hospital and follow up mortality in heart failure patients.
The study team also hypothesize that the commonest cause of acute heart failure in our
population in present era is myocardial infarction.
MATERIALS AND METHODS:
This proposed observational study is a single center HF-disease registry that will document
the routine patterns of diagnosis and medical care for heart failure as well as treatment
type, long-term HF-related clinical events, and re-admission rates following the acute
admission index event. In addition to the long-term data collection, the study will also
link treatment plans and clinical outcomes, to identify best practice in the HF treatment,
as well as extent of healthcare resources use. The registry will also collect data on
health-related quality of life.
Eligible patients and caregivers may only be included in the study after providing written
(witnessed, where required by law or regulation), IRB/IEC-approved informed consent, or, if
incapable of doing so, after such consent has been provided by a legally acceptable
representative of the patient.
RISKS AND BENEFITS There are no risks to patients participating in the registry study, as
standard of care quality will not be affected. It is unlikely that there will be any direct
benefit as a result of participation in the HF-disease registry. However, the information
contained within this non-interventional registry study will be used for research studies
directed at improving the knowledge and treatment of acute heart failure as well as
improving patients' treatment in the future.
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