Manipal Heart Failure Registry (MHFR)

NCT03157219 | Unknown DMC

• 1 other identifier: MUEC/20/2015-16
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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. 1.to enable a broad overview of the routine medical practices for HF treatment;
2. 2.to assess the healthcare resource utilization and drug utilization review for heart failure patients
3. 3.to assess the burden of disease (mortality, re-hospitalization) in the long term; and
4. 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

Keywords

Heart failure; Institutional level registry; Systolic heart failure; Acute heart failure; Heart failure India

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Treatment Pattern

  "through study completion, an average of 1 year"

• Health care resources utilization

  "through study completion, an average of 1 year"

Other Outcomes (1)

• Health related quality of life

  "through study completion, an average of 1 year"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients 18 year old, and above
• 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).

You may not qualify if:

• Patient's participation in any other clinical trial with an investigational treatment.
• 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).

Sponsors & Collaborators

• Manipal University: lead

Study Sites (1)

Dr. Ajit Singh

Manipal, Karnataka, 576104, India

RECRUITING

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Tom Devasia, MD, DM, FACC

  Manipal University

  STUDY CHAIR

• Ajit Singh, PHARM D, PhD

  Manipal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajit Singh, PHARM D, PhD

CONTACT

+919620523426; ajitjsingh.mcops@gmail.com

Yeshwanth R Karkala, MBBS, MD

CONTACT

+919880703774; yashwanthrao2000@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: September 10, 2015
• Primary Completion: September 9, 2018
• Study Completion: May 31, 2019
• Last Updated: May 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)