Heart FailureNCT04735354
Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction Patients: a Real World Study in India
An observational study of Heart Failure, run by Novartis Pharmaceuticals at 1 site in India.
Trial summary
This was a non-interventional, retrospective EMR analysis of longitudinal prescriptions in India for a period of 1.5 years. Demographic profile of patients with heart failure with reduced ejection fraction on sacubitril/valsartan was recorded. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- sacubitril/valsartan
- How many people
- 268 participants
- Where
- 1 siteIndia
- Study dates
- 27 Oct 2020to 1 Jun 2022
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥18 years with a diagnosis of HFrEF as mentioned in database or heart failure with a recording of LVEF <40% at index date with a prescription of sacubitril/valsartan
Who may be able to join
- Patients ≥18 years with a diagnosis of HFrEF as mentioned in database or heart failure with a recording of LVEF <40% at or before the index date
- A prescription of sacubitril/valsartan
Who cannot join
- Diagnosis of HF specified as preserved/mid-range ejection fraction
Trial locations and contacts
1 site in 1 country.
About this study
This was a non-interventional, retrospective EMR analysis of longitudinal prescriptions in India for a period of 1.5 years. Demographic profile of patients with heart failure with reduced ejection fraction on sacubitril/valsartan was recorded.
Read the detailed description
Index date was date of 1st prescription of sacubitril/valsartan. Dose titration of sacubitril/valsartan was assessed for a period of 6 months post index date.
- Conditions
- Heart Failure
- Being tested
- sacubitril/valsartan
- Keywords
- heart failure with reduced ejection fraction, HFrEF, India, sacubitril, valsartan, electronic medical records, EMRs, retrospective, RWE
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacubitril/valsartanDrug
There was no treatment allocation. Patients administered sacubitril/valsartan by prescription that started before inclusion of the patient into the study were enrolled.
| Study group | Role | What they receive |
|---|---|---|
| sacubitril/valsartan | Patients administered sacubitril/valsartan by prescription Receives: Drug: sacubitril/valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age information
Age information was reported
Measured: Index date
Gender information
Gender information was reported
Measured: Index date
Number of participants by Geographic area
Geographic area divided into 4 zones- North, South, East and West
Measured: idex date
Functional Class (New York Heart Association (NYHA) classification)
The New York Heart Association Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.
Measured: index date
Body Mass Index
Median value body mass index was reported
Measured: Index date
Classification of Heart Failure by etiology
Coronary artery disease, valvular, rheumatic heart disease, others, unknown.
Measured: 1.5 years
Change in ventricular function defined by Left Ventricular Ejection Fraction (LVEF)
An ejection fraction (EF) is the volumetric fraction (or portion of the total) of fluid ejected from a chamber with each contraction (or heartbeat).
Measured: Index date, 1.5 years
Medical History
type 2 diabetes, chronic obstructive pulmonary disease (COPD), anemia, chronic renal disease, atrial fibrillation, stroke, hypertension, myocardial infarction
Measured: 1.5 years
Number of participants with notable changes in laboratory parameters
Safety measured by the notable post-baseline changes in laboratory parameters compared to baseline
Measured: Baseline, 1.5 years
Number of Hospitalizations
Hospitalizations due to cardiovascular and non-cardiovascular causes
Measured: 1.5 years
Number of participants with concomitant medications
Concomitant medications classified as-
- Medications for HF: Diuretics, digitalis, beta-Blockers, ACEi, ARBs, MRA, ivabradine, SGLT2 inhibitors.
- Medications for non-HF conditions: Anti-diabetic medications other than SGLT2 inhibitors (oral and injectable), statin, antiplatelet therapy, oral anti-coagulants.
Measured: up to 6 months pre index date, Up to 6 months post index date
Number of patients with other treatments for heart failure
Other treatments for heart failure like implantable cardioverter-defibrillator (ICD), and cardiac resynchronization therapy (CRT).
Measured: 1.5 years
Secondary outcomes (9)
Persistence to sacubitril/valsartan
Defined as time duration from initiation to discontinuation of therapy.
Measured: Up to 12 months post index date
Proportion of patient discontinuing sacubitril/valsartan
Reported as frequency (n) and percentage (%).
Measured: month 2, month 4, month 6, month 8 and month 12
Maximum individual dose reached
Median value of maximum individual dose reached will be reported
Measured: 6 months post index date
Time to first dose up-titration
Median time to first dose up-titration
Measured: 6 months post index date
Time to target dose
Median time to target dose
Measured: 6 months post index date
Individual dose
The proportion of patients with a starting dose of 50 mg, 100 mg, 200 mg
Measured: 6 months post index date
Titration patterns
Listings for all titration patterns which evaluated longitudinally at the patient level as follows:
- Up-titration' corresponds to all patients who experience an initial increase in sacubitril/valsartan dose post-index,
- 'Stable up-titration' corresponds to up-titrated patients who experience no subsequent decrease in sacubitril/valsartan dose
- 'Down-titration' corresponds to all patients who experience an initial dose decrease in sacubitril/valsartan dose post-index, and
- 'Stable down-titration' corresponds to the proportion of down-titrated patients who experience no subsequent up-titration.
Measured: 1.5 years
Proportion of patients being titrated to 100mg from 50mg
Proportion of patients being titrated to 100mg from 50mg
Measured: 1.5 years
Proportion of patients being titrated to 200mg from 100mg
Proportion of patients being titrated to 200mg from 100mg
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start27 Oct 2020
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
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.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735354
- Sponsor's protocol ID
- CLCZ696BIN01
- Status last verified
- May 2023
- First submitted
- 28 Jan 2021
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction Patients: a Real World Study in India
- ClinicalTrials.gov ID
- NCT04735354
- Acronym / sponsor ID
- CLCZ696BIN01
- Conditions
- Heart Failure
- Keywords
- heart failure with reduced ejection fraction, HFrEF, India, sacubitril, valsartan, electronic medical records, EMRs, retrospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 3 Feb 2021 (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.
This was a non-interventional, retrospective EMR analysis of longitudinal prescriptions in India for a period of 1.5 years. Demographic profile of patients with heart failure with reduced ejection fraction on sacubitril/valsartan was recorded.
Detailed description
Index date was date of 1st prescription of sacubitril/valsartan. Dose titration of sacubitril/valsartan was assessed for a period of 6 months post index date.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sacubitril/valsartan | – | Drug: sacubitril/valsartanPatients administered sacubitril/valsartan by prescription |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥18 years with a diagnosis of HFrEF as mentioned in database or heart failure with a recording of LVEF <40% at index date with a prescription of sacubitril/valsartan
Key inclusion criteria (2 listed)
- Patients ≥18 years with a diagnosis of HFrEF as mentioned in database or heart failure with a recording of LVEF <40% at or before the index date
- A prescription of sacubitril/valsartan
Key exclusion criteria (1 listed)
- Diagnosis of HF specified as preserved/mid-range ejection fraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sacubitril/valsartanThere was no treatment allocation. Patients administered sacubitril/valsartan by prescription that started before inclusion of the patient into the study were enrolled. | Drug | sacubitril/valsartan |
Primary outcome
Age information
Time frame: Index date
Age information was reported
Gender information
Time frame: Index date
Gender information was reported
Number of participants by Geographic area
Time frame: idex date
Geographic area divided into 4 zones- North, South, East and West
Functional Class (New York Heart Association (NYHA) classification)
Time frame: index date
The New York Heart Association Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.
Body Mass Index
Time frame: Index date
Median value body mass index was reported
Classification of Heart Failure by etiology
Time frame: 1.5 years
Coronary artery disease, valvular, rheumatic heart disease, others, unknown.
Change in ventricular function defined by Left Ventricular Ejection Fraction (LVEF)
Time frame: Index date, 1.5 years
An ejection fraction (EF) is the volumetric fraction (or portion of the total) of fluid ejected from a chamber with each contraction (or heartbeat).
Medical History
Time frame: 1.5 years
type 2 diabetes, chronic obstructive pulmonary disease (COPD), anemia, chronic renal disease, atrial fibrillation, stroke, hypertension, myocardial infarction
Number of participants with notable changes in laboratory parameters
Time frame: Baseline, 1.5 years
Safety measured by the notable post-baseline changes in laboratory parameters compared to baseline
Number of Hospitalizations
Time frame: 1.5 years
Hospitalizations due to cardiovascular and non-cardiovascular causes
Number of participants with concomitant medications
Time frame: up to 6 months pre index date, Up to 6 months post index date
Concomitant medications classified as- * Medications for HF: Diuretics, digitalis, beta-Blockers, ACEi, ARBs, MRA, ivabradine, SGLT2 inhibitors. * Medications for non-HF conditions: Anti-diabetic medications other than SGLT2 inhibitors (oral and injectable), statin, antiplatelet therapy, oral anti-coagulants.
Number of patients with other treatments for heart failure
Time frame: 1.5 years
Other treatments for heart failure like implantable cardioverter-defibrillator (ICD), and cardiac resynchronization therapy (CRT).
9 secondary outcomes
Persistence to sacubitril/valsartan
Time frame: Up to 12 months post index date
Proportion of patient discontinuing sacubitril/valsartan
Time frame: month 2, month 4, month 6, month 8 and month 12
Maximum individual dose reached
Time frame: 6 months post index date
Time to first dose up-titration
Time frame: 6 months post index date
Time to target dose
Time frame: 6 months post index date
Individual dose
Time frame: 6 months post index date
Titration patterns
Time frame: 1.5 years
Proportion of patients being titrated to 100mg from 50mg
Time frame: 1.5 years
Proportion of patients being titrated to 200mg from 100mg
Time frame: 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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, run by Novartis Pharmaceuticals 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 1 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: finished, as of the sponsor's last update on 18 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age information (time frame: Index date). The study lists 12 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 18 May 2023.