Cardiac Contractility Modulation in Chagas Heart Disease (FIX-Chagas)
Primary Purpose
Chagas Cardiomyopathy, Heart Failure, Systolic Dysfunction
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cardiac Contractility Modulation (CCM)
CRT
Sponsored by
About this trial
This is an interventional treatment trial for Chagas Cardiomyopathy
Eligibility Criteria
Inclusion Criteria:
- Signing of an informed consent form (ICF) before randomization and any study procedure,
- Both genders, age >18 years and <75 years,
- Recent positive (last two years) and documented serology for Chagas disease, in at least two different tests (indirect hemagglutination, indirect immunofluorescence, or ELISA),
- NYHA II-III heart failure functional class,
- LVEF< 35%,
- Non left bundle branch block
- Intraventricular desynchrony (Yu index)
- Global longitudinal strain >11 %.
Exclusion Criteria:
- Participation in another study, presently or terminated <1 year ago, except for a totally unrelated observational study,
- Other concomitant cardiovascular diseases, including uncontrolled diabetes mellitus (systemic arterial hypertension without permitted target organ compromise),
- Kidney dysfunction (serum creatinine >1.5mg/dL or eGFR <30mL/min/1.73m2) or liver dysfunction, with diagnosis of cirrhosis or portal hypertension or elevated serum enzymes (AST or ALT) > 3x the upper limit of normality,
- Moderate or severe chronic obstructive pulmonary disease,
- Peripheral polyneuropathy,
- Hyperthyroidism,
- Current alcoholism or not abandoned for >2 years,
- Diagnosed with psychopathy or psychosis or addiction to illicit drugs,
- Life expectancy <1 year, due to the disease itself or comorbidities (including NYHA class IV),
- Pregnancy or breastfeeding,
- Potential to become pregnant during the study (non-menopausal patients who have not undergone a radical and safe contraceptive process),
- Previously withdrawn from this study.
Sites / Locations
- InCor - HCFMUSPRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cardiac Contractility Modulation Group - CCM Group
Cardiac Resynchronization Therapy Group - CRT Group
Arm Description
CCM implantation.
CRT implantation
Outcomes
Primary Outcome Measures
QoL Score
KCCQS - Kansas City cardiomyopathy quality score
QoL Score
KCCQS - Kansas City cardiomyopathy quality score
GLS
Global longitudinal strain at rest/effort - (tissue tracking)
GLS
Global longitudinal strain at rest/effort - (tissue tracking)
Secondary Outcome Measures
6MWT
6-minute walk test
6MWT
6-minute walk test
NYHAFC
HF functional class assessed as established by the NYHA
NYHAFC
HF functional class assessed as established by the NYHA
LVEF
Left ventricle ejection fraction
LVEF
Left ventricle ejection fraction
Heart Failure Hospitalization (HFH) checklist
Heart Failure Hospitalization
Full Information
NCT ID
NCT05519046
First Posted
August 10, 2022
Last Updated
August 26, 2022
Sponsor
InCor Heart Institute
Collaborators
Impulse Dynamics, I2medi Comercial Medica LTDA
1. Study Identification
Unique Protocol Identification Number
NCT05519046
Brief Title
Cardiac Contractility Modulation in Chagas Heart Disease
Acronym
FIX-Chagas
Official Title
Clinical and Functional Effects of Cardiac Contractility Modulation in Chagas Heart Disease: a Randomized Study - Contractility - FIX-Chagas
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
InCor Heart Institute
Collaborators
Impulse Dynamics, I2medi Comercial Medica LTDA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chagas disease is an endemic problem in Latin America, where millions of people are chronically infected with T. cruzi. Recently, it was assumed to have clinical and epidemiological relevance in several other countries due to migratory and globalizing social factors. CCC occurs in 30-50% of infected individuals, causing considerable morbidity/mortality rates. Heart failure is the most prevalent morbidity. While CRT and drug treatment have been advocated and implemented without much success to improve the clinical condition of patients with CCC, there is no consistent scientific evidence on the role of cardiac contractility modulation (CCM) as a form of adjuvant treatment for heart failure in patients with CCC.
The hypothesis of this study is that patients with CCC, advanced heart failure, severe systolic dysfunction, and non-LBB have better clinical and functional responses when undergoing implantation of a CCM device than when undergoing cardiac resynchronization therapy.
Detailed Description
Chagas Disease:
Chagas disease (Trypanosomiasis Americana) is caused by the protozoan parasite Trypanosoma cruzi, which is transmitted to humans through the feces of a hematophagous insect (family Triatominae) in most cases. The infection usually occurs in childhood, and the acute phase has an incubation period of 1 to 2 weeks and can last up to 3 months. Then follows the chronic phase, in which for a long time - 2-4 decades most of the time - patients have only positive serology for Chagas disease (CD), without symptoms or other signs of clinically apparent disease.
Therefore, such patients present the so-called indeterminate form of Chagas disease, whose prognosis is essentially benign.
While due to pathogenic mechanisms still incompletely understood, many patients remain with this form of the disease for life around 30 to 50% of infected individuals evolve to certain forms like cardiac, digestive, or mixed. Chronic Chagas cardiomyopathy (CCC) has a hemodynamic pattern like dilated idiopathic cardiomyopathy but has marked pathophysiological peculiarities. The most common and most serious clinical form of CD is responsible for significant morbidity and mortality in many Latin countries -Americans (and with epidemiological relevance also contemporarily recognized in countries with immigration by individuals from those countries).
It is estimated that 8-10 million people are infected with Trypanosoma cruzi in Latin America and other countries. Considering the worst-case scenario, we can deduce that 3-5 million infected individuals will manifest clinical forms of the disease in its chronic phase.
The disease severity:
In addition to the criteria used in the risk stratification shown in Tables 1 and 2, several markers of worse prognosis have been identified by several authors, especially concerning sudden cardiac death in different clinical contexts.
Characteristics such: as presyncope and syncope; left ventricular dysfunction; heart failure; sustained ventricular tachycardia (VT) or non-sustained ventricular tachycardia; severe bradyarrhythmia (sinus node disease and advanced atrioventricular block); and previous cardiac arrest were identified as markers of risk of sudden cardiac death (SCD). On the other hand, isolated ventricular extrasystoles on Holter monitoring and right bundle-branch block do not significantly interfere with the prognosis of CCC. SCD is often associated with manifestations of heart failure (HF), but it can also occur in patients with asymptomatic left ventricular dysfunction. It accounts for approximately 55 to 65% of all causes of death, whereas refractory HF is a cause of death in about 25 to 30% of patients and systemic or pulmonary thromboembolism in about 10 to 15%. Indicador não definido. Very rarely, aneurysm rupture can be the mechanism of sudden death in CCC.
Recently, the correlation between CCC stages and causes of mortality has been schematically described. SCD usually affects patients from stage II of the disease onwards, being more relevant in stage III and a little less in stage IV, in which refractory heart failure as a cause of death becomes quite frequent.
Therapeutic Options for Heart Failure. As in other heart diseases, the treatment of HF in CCC is based on the routine use of a combination of three types of drugs: diuretics, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers (ARB) and adrenergic beta-blockers (BB). However, despite CD representing an important cause of HF in Latin America, patients with CD and HF were not included in the large studies that validated those drugs to treat HF. Therefore, the real efficacy and tolerability of these drugs in patients with CCC have not been scientifically established, and their use is empirically extrapolated from the support obtained in HF of other etiologies.
In the same sense, the scientific evidence regarding the role of CRT in CCC is not supported by randomized studies. Furthermore, the low prevalence of left bundle block, an independent marker of CRT response, in CCC is a limiting factor for its indication of this therapeutic option. Some observational studies have been carried out to recognize other candidates for CRT in CCC, but the evidence is still poor.
Heart transplantation is a good option for severe cases, but its application is very limited by the low availability of donors.
Recently, an excellent adjunctive option was introduced, and tested in several heart diseases but not in patients with CCC. It is an implantable device capable of modulating myocardial contractility: Cardiac Contractility Modulation (CCM).
Cardiac Contractility Modulation:
CCM consists of high-tension stimulation of the right ventricular septum during the absolute refractory period, 30-40ms after cardiomyocyte activation. This stimulation acts on calcium currents and increases ventricular contractility and, as a consequence, improves functional capacity.
In a 2019 meta-analytic study, Mando R et al. evaluated four randomized studies that applied the CCM technique compared to optimized drug therapy. The authors concluded that, in short-term follow-up, there is health-related quality of life gains (as measured by the Minnesota questionnaire) and that these were significantly greater in patients treated with CCM. However, they did not observe significantly better results in the functional test evaluated by the 6-minute walk test, nor regarding mortality and hospitalization from any causes.
Abraham WT et al. performed an open-label randomized trial to evaluate the adjunctive effect of CCM therapy to optimized therapy in 160 patients with symptoms of HF functional class III or IV by NYHA classification, sinus rhythm, QRS duration <130ms, and LVEF ≥25%, and ≤45%. Of these, 74 patients underwent CCM therapy for 24 weeks. The results indicated that CCM therapy is safe and improves exercise tolerance and quality of life. The composite endpoint of cardiovascular death and HF hospitalizations was also reduced and clinical effects were observed for the entire LVEF range studied. More specifically, superior clinical efficacy was observed in patients with LVEF between 35% and 45%. These data point in the direction that CCM may be an interesting adjuvant option in HF therapy.
Hypothesis:
The hypothesis of this study is that patients with CCC, advanced heart failure, severe systolic dysfunction, and non-LBB have better clinical and functional responses when undergoing implantation of a CCM device than when undergoing cardiac resynchronization therapy.
Objectives:
Primary objective - To assess the short-term impact on quality of life and myocardial contractility of an implantable electronic cardiac device for cardiac contractility modulation compared to CRT in patients with CCC, non-LBBB, and advanced HF.
Secondary objectives - To record the clinical evolution, including the need for hospitalization, the functional class according to the New York Heart Association, and the functional capacity of an implantable electronic cardiac device for cardiac contractility modulation compared to CRT, in patients with CCC, non-LBBB, and advanced HF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chagas Cardiomyopathy, Heart Failure, Systolic Dysfunction, Right Bundle Branch Block and Left Anterior Fascicular Block, Right Bundle Branch Block and Left Posterior Fascicular Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cardiac Contractility Modulation Group - CCM Group
Arm Type
Experimental
Arm Description
CCM implantation.
Arm Title
Cardiac Resynchronization Therapy Group - CRT Group
Arm Type
Active Comparator
Arm Description
CRT implantation
Intervention Type
Device
Intervention Name(s)
Cardiac Contractility Modulation (CCM)
Intervention Description
Cardiac Contractility Modulation (CCM) implantation
Intervention Type
Device
Intervention Name(s)
CRT
Intervention Description
Cardiac Resynchronization Therapy
Primary Outcome Measure Information:
Title
QoL Score
Description
KCCQS - Kansas City cardiomyopathy quality score
Time Frame
At baseline
Title
QoL Score
Description
KCCQS - Kansas City cardiomyopathy quality score
Time Frame
At 6 months
Title
GLS
Description
Global longitudinal strain at rest/effort - (tissue tracking)
Time Frame
At baseline
Title
GLS
Description
Global longitudinal strain at rest/effort - (tissue tracking)
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
6MWT
Description
6-minute walk test
Time Frame
At baseline
Title
6MWT
Description
6-minute walk test
Time Frame
At 6 months
Title
NYHAFC
Description
HF functional class assessed as established by the NYHA
Time Frame
At baseline
Title
NYHAFC
Description
HF functional class assessed as established by the NYHA
Time Frame
At 6 months
Title
LVEF
Description
Left ventricle ejection fraction
Time Frame
At baseline
Title
LVEF
Description
Left ventricle ejection fraction
Time Frame
At 6 months
Title
Heart Failure Hospitalization (HFH) checklist
Description
Heart Failure Hospitalization
Time Frame
Through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signing of an informed consent form (ICF) before randomization and any study procedure,
Both genders, age >18 years and <75 years,
Recent positive (last two years) and documented serology for Chagas disease, in at least two different tests (indirect hemagglutination, indirect immunofluorescence, or ELISA),
NYHA II-III heart failure functional class,
LVEF< 35%,
Non left bundle branch block
Intraventricular desynchrony (Yu index)
Global longitudinal strain >11 %.
Exclusion Criteria:
Participation in another study, presently or terminated <1 year ago, except for a totally unrelated observational study,
Other concomitant cardiovascular diseases, including uncontrolled diabetes mellitus (systemic arterial hypertension without permitted target organ compromise),
Kidney dysfunction (serum creatinine >1.5mg/dL or eGFR <30mL/min/1.73m2) or liver dysfunction, with diagnosis of cirrhosis or portal hypertension or elevated serum enzymes (AST or ALT) > 3x the upper limit of normality,
Moderate or severe chronic obstructive pulmonary disease,
Peripheral polyneuropathy,
Hyperthyroidism,
Current alcoholism or not abandoned for >2 years,
Diagnosed with psychopathy or psychosis or addiction to illicit drugs,
Life expectancy <1 year, due to the disease itself or comorbidities (including NYHA class IV),
Pregnancy or breastfeeding,
Potential to become pregnant during the study (non-menopausal patients who have not undergone a radical and safe contraceptive process),
Previously withdrawn from this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martino Martinelli Filho, PhD
Phone
+551126615515
Email
martino@incor.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio F Siqueira, MsC
Phone
+551126615514
Email
sergio.siqueira@hc.fm.usp.br
Facility Information:
Facility Name
InCor - HCFMUSP
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martino MM Martinelli Filho, PHD
Phone
55 11 2661 5517
Ext
5517
Email
martino.filho@incor.usp.br
First Name & Middle Initial & Last Name & Degree
Sergio F Siqueira, Master
Phone
55 11 2661 5514
Ext
5514
Email
siqueira@incor.usp.br
12. IPD Sharing Statement
Plan to Share IPD
No
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Cardiac Contractility Modulation in Chagas Heart Disease
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