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

NCT ID: NCT05550792

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2022-03-30

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

Detailed Description

Background: Chronic heart failure (CHF) and atrial fibrillation (AF) often coexist and lead to severe decompensation of patients' lifestyle. Nowadays device therapy such as cardiac contractility modulation (CCM), which is used in addition to medical treatment, can significantly impact further prognosis and outcomes of patients with such comorbidities.

Methods: In the National Medical Research Center of Cardiology we conducted a study dedicated to investigating the efficacy of CCM in patients with CHF and AF. 200 patients with Hf and AF were included in the study and were divided into two groups according to implantation of a heart contractility modulation device and optimal drug therapy. 100 patients were implanted with a CCM Optimizer device without an atrial lead, per the protocol specifications ( 1 group) and 100 patients ( 2 group) received only optimal drug therapy CHF The following studies were performed in the 200 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),Perfusion Single-Photon Emission Computed Tomography All patients received long-term optimal drug therapy for CHF before surgery.

Conditions

Heart Failure; Atrial Fibrillation; Left Ventricular Ejection Fraction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Optimizer device

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).

Group Type: ACTIVE_COMPARATOR

optimizer smart

Intervention Type: DEVICE

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.

Without Optimizer device

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

optimizer smart

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Russian Federation

OTHER_GOV

Sponsor Role: collaborator

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

OTHER_GOV

Sponsor Role: lead

Responsible Party

Alfiya Achatovna Safiullina

sub-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alfiya Safiullina, phd

Role: PRINCIPAL_INVESTIGATOR

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Locations

Alfiya Safiullina

Moscow, , Russia

Countries

Russia

References

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.

Reference Type: RESULT

PMID: 33346425 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35057719 (View on PubMed)

Other Identifiers

КА-027-2018

Identifier Type: -

Identifier Source: org_study_id