Heart FailureMHFRNCT03157219
Manipal Heart Failure Registry (MHFR)
An observational study of Heart Failure and Systolic Heart Failure, run by Manipal University at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Systolic Heart Failure, Diastolic Heart Failure
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 10 Sep 2015to 31 May 2019
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr. Ajit Singh
Manipal, Karnataka, 576104
Ajit Singh, Pharm D, PhD, +919620523426, ajitjsingh.mcops@gmail.com
Tom Devasia, MD, DM, FACC, +919448158508, tomdevasia@hotmail.com
About this study
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
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.
Read more
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:
- to enable a broad overview of the routine medical practices for HF treatment;
- to assess the healthcare resource utilization and drug utilization review for heart failure patients
- to assess the burden of disease (mortality, re-hospitalization) in the long term; and
- to provide a novel overview of the impact of HF syndrome on quality of life as well as health economics.
Read the 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.
- 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
- Medical subject headings
- Heart Failure, Heart Failure, Systolic, Heart Failure, Diastolic
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognosis of Heart Failure
Post discharge events are measured using symptoms and treatment outcomes assessment at follow up
Measured: "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
Measured: "through study completion, an average of 1 year"
Secondary outcomes (2)
Treatment Pattern
Treatment policies for acute heart failure at admission, during hospital stay and at follow ups
Measured: "through study completion, an average of 1 year"
Health care resources utilization
disease burden and economic burden of disease
Measured: "through study completion, an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start10 Sep 2015
- Primary completion9 Sep 2018 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Manipal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ajit Singh, PhD, Manipal University
- Investigators
- Tom Devasia, MD, DM, FACC, Study chair, Manipal UniversityAjit Singh, PHARM D, PhD, Principal investigator, Manipal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157219
- Sponsor's protocol ID
- MUEC/20/2015-16
- Acronym
- MHFR
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03157219
- Acronym / sponsor ID
- MHFR / MUEC/20/2015-16
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Manipal UniversityUniversity, hospital or other
- Study start
- 10 Sep 2015 (actual)
- Primary completion
- 9 Sep 2018 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to enable a broad overview of the routine medical practices for HF treatment;
- to assess the healthcare resource utilization and drug utilization review for heart failure patients
- to assess the burden of disease (mortality, re-hospitalization) in the long term; and
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognosis of Heart Failure
Time frame: "through study completion, an average of 1 year"
Post discharge events are measured using symptoms and treatment outcomes assessment at follow up
Characterization of Heart failure
Time frame: "through study completion, an average of 1 year"
Characterization of HF is measured using in-hospital assessment at index hospitalization and discharge
2 secondary outcomes
Treatment Pattern
Time frame: "through study completion, an average of 1 year"
Health care resources utilization
Time frame: "through study completion, an average of 1 year"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Devasia, MD, DM, FACC study chair
Manipal University
Ajit Singh, PHARM D, PhD principal investigator
Manipal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Systolic Heart Failure, run by Manipal University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ajit Singh, PHARM D, PhD (+919620523426, ajitjsingh.mcops@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognosis of Heart Failure (time frame: "through study completion, an average of 1 year"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.