Manipal Heart Failure Registry (MHFR) (MHFR)

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Decompensated Heart Failure; Acute Heart Failure; Diastolic Heart Failure; Systolic Heart Failure

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Manipal, Karnataka, India, 576104
      • Recruiting
      • Dr. Ajit Singh
      • Contact: Ajit Singh, Pharm D, PhD; Phone Number: +919620523426; Email: ajitjsingh.mcops@gmail.com
      • Contact: Tom Devasia, MD, DM, FACC; Phone Number: +919448158508; Email: tomdevasia@hotmail.com
      • Principal Investigator: Ajit Singh, Pharm D, PhD
      • Sub-Investigator: Yeshwanth R Karkala, MBBS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"
Health care resources utilization	disease burden and economic burden of disease	"through study completion, an average of 1 year"

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life	Using patient questionnaire	"through study completion, an average of 1 year"

Collaborators and Investigators

• Sponsor: Manipal University
• Investigators: Study Chair: Tom Devasia, MD, DM, FACC, Manipal University; Principal Investigator: Ajit Singh, PHARM D, PhD, Manipal University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 10, 2015
• Primary Completion (ANTICIPATED): September 9, 2018
• Study Completion (ANTICIPATED): May 31, 2019

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (ACTUAL): May 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Heart failure; Acute heart failure; Systolic heart failure; Institutional level registry; Heart failure India
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Murmurs; Heart Failure; Heart Failure, Diastolic; Systolic Murmurs; Heart Failure, Systolic
• Other Study ID Numbers: MUEC/20/2015-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No