Manipal Heart Failure Registry (MHFR)

NCT03157219 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2017-05-19

No results posted yet for this study

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.

Conditions

  • Heart Failure
  • Systolic Heart Failure
  • Diastolic Heart Failure
  • Decompensated Heart Failure
  • Acute Heart Failure

Sponsors & Collaborators

  • Manipal University

    lead OTHER

Principal Investigators

  • Tom Devasia, MD, DM, FACC · Manipal University

  • Ajit Singh, PHARM D, PhD · Manipal University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-10
Primary Completion
2018-09-09
Completion
2019-05-31

Countries

  • India

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03157219 on ClinicalTrials.gov