An observational study in Heart Failure, Systolic Heart Failure and Diastolic Heart Failure, sponsored by Manipal University. Status unknown at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-19.
Sponsored by Manipal University · Observational
Among 83 studies in Heart Failure with a site in India — 15 open to participants now, 18 under way, 9 of them phase 3. Heart Failure · India.
Among the 83 studies in Heart Failure with a site in India, this one is the 13th largest by planned enrollment of the 17 observational ones that give a count, is one of 2 that started in 2015, is one of 17 observational ones, and was the 43rd registered.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
Browse Heart Failure studies →15 of the 83 studies in Heart Failure with a site in India are open now. Recruiting first, the newest first:
AstraZeneca · Sites in India, United States, Argentina and 29 more countries
Novo Nordisk A/S · Sites in India, United States, Argentina and 24 more countries
Abbott Medical Devices · Sites in India, Brazil, France and 6 more countries
Novo Nordisk A/S · Sites in India, Australia, Czechia and 7 more countries
Novo Nordisk A/S · Sites in India, United States, Canada and 6 more countries
A study can be open while its sites in India have not opened yet or have stopped. Only those recruiting at a site in India →
Of the 968 Heart Failure studies recruiting now, 691 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 64 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
83 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 9 · Phase 3 33 · Phase 4 6
First in 1983; this study’s year is marked. 2 started in 2015.
This study's planned enrollment of 500 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Median enrollment 977 across the 66 interventional studies, 870 across the 17 observational. Of the 60 that completed or were terminated, 33 (55%) have results posted.
This tab as a report to print or save as PDF → With an account.
71 of 83 have an industry lead sponsor. The 10 most frequent:
Manipal University is the lead sponsor of 6 studies on the registry; none are open to participants now.
Manipal University has 1 study filed under Heart Failure — fewer than ten, so there is no comparison to draw.
7 of the studies in Heart Failure with a site in India that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06307652Phase 3AstraZenecaStudy to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function | 2027-04-16 |
| NCT06024746Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF) | 2027-11 |
| NCT06008197Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients | 2027-11 |
| NCT07817589Centre for Chronic Disease Control, IndiaYoga Based Cardiac Rehabilitation in Heart Failure Failure | 2026-11-30 |
| NCT07217392Abbott Medical DevicesLeft Bundle Branch Area Pacing (LBBAP) PMCF Study | 2027-04-30 |
Among the 83 studies in Heart Failure with a site in India, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prognosis of Heart Failure
Post discharge events are measured using symptoms and treatment outcomes assessment at follow up
Time frame: "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
Time frame: "through study completion, an average of 1 year"
Treatment Pattern
Treatment policies for acute heart failure at admission, during hospital stay and at follow ups
Time frame: "through study completion, an average of 1 year"
Health care resources utilization
disease burden and economic burden of disease
Time frame: "through study completion, an average of 1 year"
Health related quality of life
Using patient questionnaire
Time frame: "through study completion, an average of 1 year"
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2015 (actual). Primary completion is estimated for Sep 2018, 35 months after the start.
Of 793 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's planned 35 months is below that.
Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Manipal University