Brief Summary

Chronic heart failure (CHF) is a global pandemic which affects around 26 million people worldwide and develops in 10% of people over 70 years . According to the results of the EPOCHA-CHF study, CHF is detected in 7-10% of cases in the Russian Federation . Atrial fibrillation (AF) is the most common arrhythmia in patients with both preserved (HFpEF) and reduced ejection fraction (HFrEF) heart failure. The prognostic impact of AF on CHF is negative, including the significant increase in mortality and hospitalization. One of the common causes of decompensation of CHF is AF. The debut of AF in CHF is one of the markers of disease progression. Rapid development in interventional cardiology due to the invention of cardiac catheter technologies during the last decades provided a new option for non-pharmacological treatment of CHF. Nowadays the use of electrophysiological methods of treatment can significantly improve the prognosis of CHF. Pacemakers, cardiac resynchronization devices, and cardioverter defibrillators are the most commonly implanted devices in patients with CHF. In 2014, the European Society of Cardiology presented a report of the European Heart Rhythm Association on the use of new devices for CHF, including the Optimizer device for delivery of cardiac contractility modulation therapy (CCM) . It is worth noting that CCM is a new step in the CHF treatment. This device is of proven benefit to patients with symptomatic heart failure on optimal medical therapy who do not qualify for cardiac resynchronization therapy. Multiple studies of CCM show clinical improvement with this therapy, including metrics such as peak VO2, 6MW, and NYHA functional class. However, the vast majority of patients enrolled in these studies were patients in sinus rhythm. As the technology progressed and the need for the trial sensing led wanted, further experiences incorporated patients with AF. A new generation of devices (Optimizer Smart®), which does not require the implantation of an atrial electrode made it possible to implant CCM in patients with AF. The present trial demonstrates the results of a pilot study conducted in National Medical Research Center of Cardiology Ministry of Health of the Russian Federation which compares the efficacy of CCM in patients with AF and ischemic and non-ischemic CHF compared to patients who received only optimal drug therapy CHF

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

200

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline

Completed

Started Aug 2018

Typical duration for not_applicable heart-failure

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.6 years study duration

Study Start

First participant enrolled

August 31, 2018

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed

2.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2022

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed

6 months until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed

Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

January 26, 2022

Last Update Submit

September 20, 2022

Conditions

Heart Failure Atrial Fibrillation Left Ventricular Ejection Fraction

Keywords

Cardiac contractility modulationAtrial FibrillationHeart FailureNarrow QRS Complexleft ventricular ejection fraction

Outcome Measures

Primary Outcomes (1)

cardiovascular death + hospitalization due to decompensation of HF
Number of Participants with cardiovascular death + hospitalization due to decompensation of HF
12 month

Secondary Outcomes (5)

death from all causes
12 month
hospitalization for any reason
12 month
development of AF paroxysm in patients with paroxysmal AF
12 month
worsening of the course of CHF, which required an outpatient visit and increased doses of diuretics
12 month
complications that required removal of the MCC
12 month

Study Arms (2)

Optimizer device

ACTIVE COMPARATOR

100 patients were enrolled sequentially, 100 patients were implanted with an optimizer smart against the background of optimal drug therapy for heart failure 100 patients were implanted with a CCM Optimizer device without an atrial lead, per the protocol specifications recived optimal drug therapy CHF The following studies were performed in the 100 patients with CHF and AF before implantation of the MCC device and after 2 and 6 и 12 months of follow-up: 12-channel ECG with an estimate of the width of the QRS complex, transthoracic EchoCG,Speckle-tracking EchoCG,Myocardial work, 6-minute walk test, determination of the level of Pro-natriuretic N-terminal peptide (NT-proBNP), Holter ECG, and a questionnaire based on the Minnesota quality of life questionnaire for patients with CHF (MHFLQ).

Device: optimizer smart

Without Optimizer device

NO INTERVENTION

100 patients were enrolled sequentially,100 patients received only optimal drug therapy for chronic heart failure 100 patients ( Without Optimizer device ) with CHF and AF before study and after 2 and 6 и 12 months of follow-up: 12-channel ECG with an estimate of the width of the QRS complex, transthoracic EchoCG,Speckle-tracking EchoCG,Myocardial work, 6-minute walk test, determination of the level of Pro-natriuretic N-terminal peptide (NT-proBNP), Holter ECG, and a questionnaire based on the Minnesota quality of life questionnaire for patients with CHF (MHFLQ).

Interventions

optimizer smartDEVICE

The CCM implantation procedure was performed in the right precordial region of the chest (the right subclavian area). Two active fixation Ingevity leads (Boston Scientific) were advanced via the right subclavian vein into the right ventricle (RV) and actively fixed to the right ventricular septum for ventricular sensing and delivery of CCM signals.

Optimizer device

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Documented HFrEF (20-40%)
NYHA FC II-III for at least 3 months before screening
Optimal CHF therapy and the absence of decompensations in ≥ 1 month.

You may not qualify if:

Refusal to participate in the study
Placement on the heart transplant waiting list, or post heart transplantation
Terminal CHF
Co-morbid diseases that may adversely affect the safety and / or efficacy of treatment
Recent surgical intervention or trauma
Medical conditions that limit life expectancy to 1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfiya Safiullina

Moscow, 121552, Russia

Location

Related Publications (2)

Uskach TM, Safiullina AA, Sapel'nikov OV, Amanatova VA, Nikolaeva OA, Grishin IR, Nazarov BM, Tereshchenko SN. [Modulation of cardiac contractility in patients with chronic heart failure and atrial fibrillation]. Ter Arkh. 2020 Oct 14;92(9):8-14. doi: 10.26442/00403660.2020.09.000598. Russian.
PMID: 33346425RESULT
Dobrovolskaya SV, Saidova MA, Safiullina AA, Uskach TM, Tereshchenko SN. [Evaluation of the effectiveness of the chronic heart failure therapy using the device cardiac contractility modulation according to the new non-invasive method of the myocardium work analysis]. Kardiologiia. 2021 Dec 31;61(12):31-40. doi: 10.18087/cardio.2021.12.n1849. Russian.
PMID: 35057719RESULT

MeSH Terms

Conditions

Heart FailureAtrial Fibrillation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Alfiya Safiullina, phd
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: sub-Investigator

Study Record Dates

First Submitted

January 26, 2022

First Posted

September 22, 2022

Study Start

August 31, 2018

Primary Completion

December 10, 2019

Study Completion

March 30, 2022

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing: Will not share

Locations

RU(1)

Cardiac Contractility Modulation in Patients With Chronic Heart Failure and the Various Forms of Atrial Fibrillation

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Optimizer device

Without Optimizer device

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Optimizer device

Without Optimizer device

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations