Heart FailureSAVE-ICDNCT03935087
Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan
An observational study of Heart Failure, run by Azienda Ospedaliera Cardinale G. Panico at 6 sites in Italy.
Trial summary
The study is aimed to evaluate the improvement of the left ventricular volumes and of the left ventricular ejection fraction in a population of ICD patients with heart failure and left ventricle systolic dysfunction undergoing therapy with Sacubitril/Valsartan (according to current Guidelines), during a 6-month… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- two-dimensional echocardiogram
- How many people
- 150 participants
- Where
- 6 sitesItaly
- Study dates
- 1 Aug 2018to 30 Jun 2019
- How long will I take part?
- 6 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: Patients with heart failure, left ventricular systolic dysfunction, carrying a single-chamber or a bicameral implantable cardioverter defibrillator implanted for primary prevention of sudden death, and undergoing therapy with Sacubitril/Valsartan according to current Guidelines
Who may be able to join
- heart failure
- left ventricular systolic dysfunction
- carrying a single-chamber or a bicameral implantable cardioverter defibrillator implanted for primary prevention of sudden death
- undergoing therapy with Sacubitril/Valsartan according to current Guidelines
Who cannot join
- age <18 years
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites, 6 recruiting
- Recruiting
Federico Guerra
Ancona
Federico Guerra, MD, +393333862467, matziacc@libero.it
- Recruiting
Policlinico S.Orsola-Malpighi
Bologna, 40138
Matteo Ziacchi, MD, +393476785656, matteo.ziacchi@gmail.com
- Recruiting
AO Pugliese-Ciaccio
Catanzaro, 88100
Vittorio Aspromonte, MD, +393472536524, dott.vittorioaspromonte@gmail.com
- Recruiting
Monaldi Hospital
Naples
Ernesto Ammendola, MD, +393382841171, ammendolaernesto@libero.it
- Recruiting
AOU "Maggiore della Carità"
Novara, 28100
Gabriele Dell'Era, MD, +393296575400, gdellera@gmail.com
- Recruiting
"Card. G. Panico" Hospital
Tricase, Lecce, 73039
Pietro Palmisano, MD, +390833773111, dr.palmisano@libero.it
About this study
Official title: Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan and Potential Impact on ICD Implant Rates for Primary Prevention of Sudden Cardiac Death (SAVE-ICD)
The study is aimed to evaluate the improvement of the left ventricular volumes and of the left ventricular ejection fraction in a population of ICD patients with heart failure and left ventricle systolic dysfunction undergoing therapy with Sacubitril/Valsartan (according to current Guidelines), during a 6-month follow-up.
Read the detailed description
Consecutive, unselected patients with heart failure and left ventricle systolic dysfunction, carrying a single-chamber or a bicameral implantable cardioverter defibrillator (ICD) for primary prevention of sudden death, undergoing therapy with Sacubitril/Valsartan (according to current Guidelines) will be enrolled in the study. A two-dimensional echocardiogram with evaluation of left ventricular end-diastolic volume, left ventricular end-systolic volume, and left ventricular ejection fraction will be performed, according to standard clinical practice, at the beginning of the observation, and at a 6-month follow-up. The improvement of the left ventricle volumes and of the left ventricular ejection fraction will be evaluated.
- Conditions
- Heart Failure
- Being tested
- two-dimensional echocardiogram
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two-dimensional echocardiogramDiagnostic test
two-dimensional echocardiogram with evaluation of left ventricle volumes and of left ventricular ejection fraction
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in left ventricular ejection fraction
Difference between the ejection fraction observed at baseline and that observed at 6 months of follow-up
Measured: at enrollment and at 6 months of follow-up
Secondary outcomes (1)
Reduction in left ventricle volumes
Difference between the left ventricle volumes measured at baseline and those measured at 6 months of follow-up
Measured: at enrollment and at 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Aug 2018
- Primary completion31 May 2019 (estimated)
- Study completion30 Jun 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
- 150 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Cardinale G. Panico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935087
- Sponsor's protocol ID
- SAVE-ICD
- Acronym
- SAVE-ICD
- Status last verified
- Apr 2019
- First submitted
- 30 Apr 2019
- Last updated
- 2 May 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 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan and Potential Impact on ICD Implant Rates for Primary Prevention of Sudden Cardiac Death (SAVE-ICD)
- ClinicalTrials.gov ID
- NCT03935087
- Acronym / sponsor ID
- SAVE-ICD / SAVE-ICD
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Cardinale G. PanicoUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 2 May 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.
The study is aimed to evaluate the improvement of the left ventricular volumes and of the left ventricular ejection fraction in a population of ICD patients with heart failure and left ventricle systolic dysfunction undergoing therapy with Sacubitril/Valsartan (according to current Guidelines), during a 6-month follow-up.
Detailed description
Consecutive, unselected patients with heart failure and left ventricle systolic dysfunction, carrying a single-chamber or a bicameral implantable cardioverter defibrillator (ICD) for primary prevention of sudden death, undergoing therapy with Sacubitril/Valsartan (according to current Guidelines) will be enrolled in the study. A two-dimensional echocardiogram with evaluation of left ventricular end-diastolic volume, left ventricular end-systolic volume, and left ventricular ejection fraction will be performed, according to standard clinical practice, at the beginning of the observation, and at a 6-month follow-up. The improvement of the left ventricle volumes and of the left ventricular ejection fraction will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure, left ventricular systolic dysfunction, carrying a single-chamber or a bicameral implantable cardioverter defibrillator implanted for primary prevention of sudden death, and undergoing therapy with Sacubitril/Valsartan according to current Guidelines
Key inclusion criteria (4 listed)
- heart failure
- left ventricular systolic dysfunction
- carrying a single-chamber or a bicameral implantable cardioverter defibrillator implanted for primary prevention of sudden death
- undergoing therapy with Sacubitril/Valsartan according to current Guidelines
Key exclusion criteria (1 listed)
- age <18 years
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 |
|---|---|---|
| two-dimensional echocardiogramtwo-dimensional echocardiogram with evaluation of left ventricle volumes and of left ventricular ejection fraction | Diagnostic test | – |
Primary outcome
Improvement in left ventricular ejection fraction
Time frame: at enrollment and at 6 months of follow-up
Difference between the ejection fraction observed at baseline and that observed at 6 months of follow-up
1 secondary outcome
Reduction in left ventricle volumes
Time frame: at enrollment and at 6 months of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
6 sites 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 Azienda Ospedaliera Cardinale G. Panico at 6 sites in Italy.
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 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: status not confirmed, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in left ventricular ejection fraction (time frame: at enrollment and at 6 months of follow-up). 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 2 May 2019; AzTrials last refreshed its copy on 6 Nov 2026.