Clinical trial NCT03157219: Manipal Heart Failure Registry (MHFR)
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Systolic Heart Failure
Diastolic Heart Failure
Decompensated Heart Failure
Acute Heart Failure
Keywords: Heart failure
Institutional level registry
Systolic heart failure
Acute heart failure
Heart failure India
Lead sponsor: Manipal University
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The registry will include adult patients (age \>18 years) diagnosed with acute-HF with or without co-morbidities at the time of hospitalization

No specific population required

Asian race

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Prognosis of Heart Failure
timeFrame: "through study completion, an average of 1 year"
measure: Characterization of Heart failure
timeFrame: "through study completion, an average of 1 year"
Secondary outcomes:
measure: Treatment Pattern
timeFrame: "through study completion, an average of 1 year"
measure: Health care resources utilization
timeFrame: "through study completion, an average of 1 year"
Other outcomes:
measure: Health related quality of life
timeFrame: "through study completion, an average of 1 year"
Locations:
city: Manipal
country: India
facility: Dr. Ajit Singh
state: Karnataka
Study officials:
affiliation: Manipal University
name: Tom Devasia, MD, DM, FACC
role: STUDY_CHAIR
affiliation: Manipal University
name: Ajit Singh, PHARM D, PhD
role: PRINCIPAL_INVESTIGATOR
References: