Heart Failure Clinical Trial
— MHFROfficial 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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | May 31, 2019 |
Est. primary completion date | September 9, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients 18 year old, and above 2. Patients with a documented diagnosis of Acute heart failure (or chronic heart failure with acute exacerbations) as decided by the physician according to local practices and their clinical judgment (i.e., History/examination; Chest X-ray; ECG, Echocardiogram, BNP or NT-proBNP). Exclusion Criteria: 1. Patient's participation in any other clinical trial with an investigational treatment. 2. Use of investigational drugs within 5 half-lives of enrolment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer (as guideline, last dose for small molecules should have occurred more than 30 days, and for biologics more than 4 months prior to enrolment). |
Country | Name | City | State |
---|---|---|---|
India | Dr. Ajit Singh | Manipal | Karnataka |
Lead Sponsor | Collaborator |
---|---|
Manipal University |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Health related quality of life | Using patient questionnaire | "through study completion, an average of 1 year" | |
Primary | Prognosis of Heart Failure | Post discharge events are measured using symptoms and treatment outcomes assessment at follow up | "through study completion, an average of 1 year" | |
Primary | Characterization of Heart failure | Characterization of HF is measured using in-hospital assessment at index hospitalization and discharge | "through study completion, an average of 1 year" | |
Secondary | Treatment Pattern | Treatment policies for acute heart failure at admission, during hospital stay and at follow ups | "through study completion, an average of 1 year" | |
Secondary | Health care resources utilization | disease burden and economic burden of disease | "through study completion, an average of 1 year" |
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