Drug EffectNCT03830814
The Effects of Sacubitril/Valsartan on the Heart Functions
An observational study of Drug Effect, run by The Young Investigator Group of Cardiovascular Research.
Trial summary
Background: Sacubitril/valsartan, has been found to be more beneficial than enalapril for reducing the incidences of sudden cardiac death, death from worsening heart failure (HF), and hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Effect
- What is being tested?
- Echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Jul 2018
- How long will I take part?
- 3 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: One hundred patients with heart failure with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines were prospectively enrolled.
Who may be able to join
- Age is more than or equal 18 years old
- Able to provide written informed consent
- Indicated for the use of sacubitril/valsartan as recommended by the European Society of Cardiology (ESC) heart failure guidelines 2016
- Left ventricular ejection fraction of 40% or less
Who cannot join
- Cardiac resynchronization therapy (CRT) device implantation less than 3 months prior to the start of this study or CRT implantation intentions
- Atrial fibrillation
- Poor echocardiographic images
- Sacubitril/valsartan treatment intolerance during the follow-up period
About this study
Official title: What Are the Effects of Sacubitril/Valsartan on the Heart Functions? Can It Increase the Ejection Fraction?
Background:
Sacubitril/valsartan, has been found to be more beneficial than enalapril for reducing the incidences of sudden cardiac death, death from worsening heart failure (HF), and hospitalization. However, there is no prospective echocardiographic data describing the effects of sacubitril/valsartan on the heart functions and left ventricular (LV) reverse remodeling. Therefore, the aim of our study was to evaluate the effects of sacubitril/valsartan on the LV functions using two dimensional (2D), three dimensional (3D) echocardiography and the 3D strain parameters.
Read more
Methods:
In 100 patients with HF with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines were prospectively enrolled. The basal 2D and 3D echocardiographic parameters were compared to those obtained 3 months after starting the sacubitril/valsartan treatment.
- Conditions
- Drug Effect
- Being tested
- Echocardiography
- Keywords
- Sacubitril/Valsartan, Heart Failure, Ejection Fraction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyProcedure or surgery
Basal two dimensional and three dimensional echocardiographic parameters were compared to those obtained 3 months after starting the sacubitril/valsartan treatment
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with heart failure with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines Receives: Procedure: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two dimensional left ventricular ejection fraction
Two dimensional ejection fraction is measured as baseline and after 3 months follow-up
Measured: 3 months
Three dimensional left ventricular ejection fraction
Three dimensional ejection fraction is measured as baseline and after 3 months follow-up
Measured: 3 months
Secondary outcomes (2)
Two dimensional left ventricular volumes
Two dimensional left ventricular volumes are measured as baseline and after 3 months follow-up
Measured: 3 months
Three dimensional left ventricular volumes
Three dimensional left ventricular volumes are measured as baseline and after 3 months follow-up
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Jan 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug EffectStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- The Young Investigator Group of Cardiovascular Research
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830814
- Sponsor's protocol ID
- YIG01201901
- Status last verified
- Feb 2019
- First submitted
- 1 Feb 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Effects of Sacubitril/Valsartan on the Heart Functions? Can It Increase the Ejection Fraction?
- ClinicalTrials.gov ID
- NCT03830814
- Acronym / sponsor ID
- YIG01201901
- Conditions
- Drug Effect
- Keywords
- Sacubitril/Valsartan, Heart Failure, Ejection Fraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Young Investigator Group of Cardiovascular ResearchResearch network
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 5 Feb 2019 (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.
Background:
Sacubitril/valsartan, has been found to be more beneficial than enalapril for reducing the incidences of sudden cardiac death, death from worsening heart failure (HF), and hospitalization. However, there is no prospective echocardiographic data describing the effects of sacubitril/valsartan on the heart functions and left ventricular (LV) reverse remodeling. Therefore, the aim of our study was to evaluate the effects of sacubitril/valsartan on the LV functions using two dimensional (2D), three dimensional (3D) echocardiography and the 3D strain parameters.
Methods:
In 100 patients with HF with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines were prospectively enrolled. The basal 2D and 3D echocardiographic parameters were compared to those obtained 3 months after starting the sacubitril/valsartan treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Procedure: EchocardiographyPatients with heart failure with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred patients with heart failure with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines were prospectively enrolled.
Key inclusion criteria (4 listed)
- Age is more than or equal 18 years old
- Able to provide written informed consent
- Indicated for the use of sacubitril/valsartan as recommended by the European Society of Cardiology (ESC) heart failure guidelines 2016
- Left ventricular ejection fraction of 40% or less
Key exclusion criteria (4 listed)
- Cardiac resynchronization therapy (CRT) device implantation less than 3 months prior to the start of this study or CRT implantation intentions
- Atrial fibrillation
- Poor echocardiographic images
- Sacubitril/valsartan treatment intolerance during the follow-up period
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 |
|---|---|---|
| EchocardiographyBasal two dimensional and three dimensional echocardiographic parameters were compared to those obtained 3 months after starting the sacubitril/valsartan treatment | Procedure or surgery | Cases |
Primary outcome
Two dimensional left ventricular ejection fraction
Time frame: 3 months
Two dimensional ejection fraction is measured as baseline and after 3 months follow-up
Three dimensional left ventricular ejection fraction
Time frame: 3 months
Three dimensional ejection fraction is measured as baseline and after 3 months follow-up
2 secondary outcomes
Two dimensional left ventricular volumes
Time frame: 3 months
Three dimensional left ventricular volumes
Time frame: 3 months
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 5 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Effect, run by The Young Investigator Group of Cardiovascular Research.
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 4 inclusion and 4 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Two dimensional left ventricular ejection fraction (time frame: 3 months). 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 5 Feb 2019.