Heart Failure With Reduced Ejection FractionPERFECTNCT05539898
Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Arrhythmic Risk Stratification
A study testing ICD implantation in people with Heart Failure With Reduced Ejection Fraction, run by Astrakhan Federal Centre For Cardiac Surgery at 1 site in Russia.
Trial summary
A number of large randomized studies have demonstrated the importance of left ventricle ejection fraction (LV EF) for ventrucular tachyarhrythmia's (VT) prediction. The use of this indicator as the sole predictor of high arrhythmic risk requiring ICD implantation is enshrined in the current clinical recommendations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- ICD implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteRussia
- Study dates
- 13 Jan 2017to 29 Dec 2024
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LV EF ≤ 35% inspite of optimal drug therapy of heart failure (3 months and longer)
- NYHA II-IV
- favorable prediction of survival for 1 year or more
Who cannot join
- secondary SCD prevention
- indications for open heart surgery
- hypertrophic cardiomyopathy
- arrhythmogenic right ventricular dysplasia
- genetic channelopathies
Trial locations and contacts
1 site in 1 country.
Nikolay N Ilov, MD contact
Russia1 site, 1 recruiting
- Recruiting
Federal Center for Cardiovascular Surgery
Astrakhan, Astrakhan Oblast, 414000
Nikolay Ilov, MD, nikolay.ilov@gmail.com
About this study
Official title: Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Stratification of the Risk of Stable Ventricular Tachyarrhythmias
A number of large randomized studies have demonstrated the importance of left ventricle ejection fraction (LV EF) for ventrucular tachyarhrythmia's (VT) prediction. The use of this indicator as the sole predictor of high arrhythmic risk requiring ICD implantation is enshrined in the current clinical recommendations. At the same time, many experts consider LV EF as too generalized indicator, which can be an integral indicator of total cardiovascular mortality, but lacks specificity in determining the risk of VT. It is known that only about 20% of patients with ICD implanted for primary prevention of sudden cardiac death (SCD) receive appropriate life-saving therapy.
Purpose of the study: to develop additional criteria for selection of patients with heart failure for implantation of cardioverter-defibrillator for the purpose of primary SCD prevention on the basis of stratification of the risk of occurrence of stable ventricular tachyarrhythmias.
- Being tested
- ICD implantation
- Keywords
- sudden cardiac death, heart failure, primary prevention, risk stratification
- Medical subject headings
- Death, Sudden, Cardiac, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD implantationDevice
All included in the study will undergo ICD implantation for primary prevention of SCD
| Study group | Role | What they receive |
|---|---|---|
| ICD | Other | ICD implanted Receives: Device: ICD implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of VT primary occurrence
A stable paroxysm of VT (lasting ≥ 30 seconds) detected in the "monitoring" zone of VT, or paroxysm of VT, requiring ICD therapy.
Measured: 24 months
Secondary outcomes (2)
Rate of Cardiac Mortality
Registration of cardiac death
Measured: 24 months
Number of Participants with CRT Response
Registration of CRT Response evaluated by transthoracic echocardiography
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start13 Jan 2017
- Primary completion29 Dec 2023 (estimated)
- Study completion29 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astrakhan Federal Centre For Cardiac Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolay Ilov, Astrakhan Federal Centre For Cardiac Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539898
- Sponsor's protocol ID
- ONRS_01
- Acronym
- PERFECT
- Status last verified
- Jan 2023
- First submitted
- 12 Sep 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ilov NN, Palnikova OV, Stompel DR, Nechepurenko capital A, CyrillicA. Clinical Predictors of Occurrence of Ventricular Tachyarrhythmias in Patients with Reduced Left Ventricle Ejection Fraction. Results of Single-Center Prospective Study. Kardiologiia. 2021 May 31;61(5):32-40. doi: 10.18087/cardio.2021.5.n1480. English, Russian.
PubMed 34112073
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Stratification of the Risk of Stable Ventricular Tachyarrhythmias
- ClinicalTrials.gov ID
- NCT05539898
- Acronym / sponsor ID
- PERFECT / ONRS_01
- Keywords
- sudden cardiac death, heart failure, primary prevention, risk stratification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Astrakhan Federal Centre For Cardiac SurgeryUniversity, hospital or other
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 29 Dec 2023 (estimated)
- Study completion
- 29 Dec 2024 (estimated)
- First posted
- 14 Sep 2022 (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.
A number of large randomized studies have demonstrated the importance of left ventricle ejection fraction (LV EF) for ventrucular tachyarhrythmia's (VT) prediction. The use of this indicator as the sole predictor of high arrhythmic risk requiring ICD implantation is enshrined in the current clinical recommendations. At the same time, many experts consider LV EF as too generalized indicator, which can be an integral indicator of total cardiovascular mortality, but lacks specificity in determining the risk of VT. It is known that only about 20% of patients with ICD implanted for primary prevention of sudden cardiac death (SCD) receive appropriate life-saving therapy.
Purpose of the study: to develop additional criteria for selection of patients with heart failure for implantation of cardioverter-defibrillator for the purpose of primary SCD prevention on the basis of stratification of the risk of occurrence of stable ventricular tachyarrhythmias.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD | Other | Device: ICD implantationICD implanted |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- LV EF ≤ 35% inspite of optimal drug therapy of heart failure (3 months and longer)
- NYHA II-IV
- favorable prediction of survival for 1 year or more
Key exclusion criteria (5 listed)
- secondary SCD prevention
- indications for open heart surgery
- hypertrophic cardiomyopathy
- arrhythmogenic right ventricular dysplasia
- genetic channelopathies
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 |
|---|---|---|
| ICD implantationAll included in the study will undergo ICD implantation for primary prevention of SCD | Device | ICD |
Primary outcome
Rate of VT primary occurrence
Time frame: 24 months
A stable paroxysm of VT (lasting ≥ 30 seconds) detected in the "monitoring" zone of VT, or paroxysm of VT, requiring ICD therapy.
2 secondary outcomes
Rate of Cardiac Mortality
Time frame: 24 months
Number of Participants with CRT Response
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Results publication: PubMed 34112073Ilov NN, Palnikova OV, Stompel DR, Nechepurenko capital A, CyrillicA. Clinical Predictors of Occurrence of Ventricular Tachyarrhythmias in Patients with Reduced Left Ventricle Ejection Fraction. Results of Single-Center Prospective Study. Kardiologiia. 2021 May 31;61(5):32-40. doi: 10.18087/cardio.2021.5.n1480. English, Russian.
- 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.
Nikolay N Ilov, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICD implantation in people with Heart Failure With Reduced Ejection Fraction, run by Astrakhan Federal Centre For Cardiac Surgery at 1 site in Russia.
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 3 inclusion and 5 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 1 Feb 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 Russia. 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?
Contact Nikolay N Ilov, MD (nikolay.ilov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of VT primary occurrence (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05539898, which also lists 1 linked publication.
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 1 Feb 2023.