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出境医 / 临床实验 / Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan (SAVE-ICD)
Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan (SAVE-ICD)
Study Description
Brief 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 follow-up.
| Condition or disease | Intervention/treatment |
|---|---|
| Heart Failure | Diagnostic Test: two-dimensional echocardiogram |
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
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 6 Months |
| 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) |
| Actual Study Start Date : | August 1, 2018 |
| Estimated Primary Completion Date : | May 31, 2019 |
| Estimated Study Completion Date : | June 30, 2019 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Reduction in left ventricle volumes [ Time Frame: at enrollment and at 6 months of follow-up ]Difference between the left ventricle volumes measured at baseline and those measured at 6 months of follow-up
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 30, 2019 | ||||
| First Posted Date | May 2, 2019 | ||||
| Last Update Posted Date | May 2, 2019 | ||||
| Actual Study Start Date | August 1, 2018 | ||||
| Estimated Primary Completion Date | May 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
Reduction in left ventricle volumes [ Time Frame: at enrollment and at 6 months of follow-up ] Difference between the left ventricle volumes measured at baseline and those measured at 6 months of follow-up
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan | ||||
| 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) | ||||
| Brief 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 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 Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | 6 Months | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| 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 | ||||
| Condition | Heart Failure | ||||
| Intervention | Diagnostic Test: two-dimensional echocardiogram
two-dimensional echocardiogram with evaluation of left ventricle volumes and of left ventricular ejection fraction
|
||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
150 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | June 30, 2019 | ||||
| Estimated Primary Completion Date | May 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Italy | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03935087 | ||||
| Other Study ID Numbers | SAVE-ICD | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Azienda Ospedaliera Cardinale G. Panico | ||||
| Study Sponsor | Azienda Ospedaliera Cardinale G. Panico | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Azienda Ospedaliera Cardinale G. Panico | ||||
| Verification Date | April 2019 | ||||
