Heart Failure Clinical Trial
— PhysioSync-HFOfficial title:
Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure (PhysioSync-HF)
Verified date | December 2023 |
Source | Hospital Moinhos de Vento |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the effect of conduction system pacing versus biventricular pacing on death, worsening heart failure, and left ventricular ejection fraction in patients with chronic heart failure with reduced ejection fraction and left bundle branch block.
Status | Active, not recruiting |
Enrollment | 179 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - Male or female, age =18 years - Established diagnosis of symptomatic heart failure (New York Heart Association class II-III) - Left ventricular ejection fraction =35% in prior 3 months - Left bundle branch block (QRS =130 ms) - Clinical indication for cardiac resynchronization therapy - Patients should be clinically stable - Patients should receive background standard of care for heart failure with reduced ejection fraction, with the maximum tolerated doses of ACE inhibitor or ARB or ARNI, beta-blocker, and mineralocorticoid receptor antagonist Exclusion criteria: - Life expectancy <12 months due to any disease - Dementia or advanced cerebrovascular disease - NYHA class IV - Plan to implant an implantable cardioverter defibrillator (ICD), with or without resynchronization therapy (CRT-D) - Enrollment in other clinical trials involving cardiac pacing - Pregnancy or pre-menopausal women who do not use regular contraceptive methods - Patients unable to understand and sign the consent for participation |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Geral Universitário de Cuiabá | Cuiabá | Mato Grosso |
Brazil | SOS Cardio | Florianópolis | Santa Catarina |
Brazil | Fundação Hospital do Coração Francisca Mendes | Manaus | Amazonas |
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
Brazil | Hospital Mãe de Deus | Porto Alegre | Rio Grande Do Sul |
Brazil | Hospital Moinhos de Vento | Porto Alegre | Rio Grande Do Sul |
Brazil | Instituto de Medicina Integral Professor Fernando Figueira | Recife | Pernambuco |
Brazil | Instituto Nacional de Cardiologia | Rio De Janeiro | |
Brazil | Hospital Ana Nery | Salvador | Bahia |
Brazil | Instituto de Cardiologia de Santa Catarina | São José | Santa Catarina |
Brazil | Beneficência Portuguesa | São Paulo | |
Brazil | Hospital Alemão Oswaldo Cruz | São Paulo | |
Brazil | Hospital Universitário da Universidade Federal do Piauí | Teresina | Piauí |
Brazil | Hospital Universitário Cassiano Antônio de Moraes | Vitória | Espírito Santo |
Lead Sponsor | Collaborator |
---|---|
Hospital Moinhos de Vento | Ministry of Health, Brazil |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score | The Kansas City Cardiomyopathy Questionnaire Overall Summary Score ranges from 0-100, where a lower score indicates a worse outcome. | 12 months | |
Other | Change in NYHA Classification | New York Heart Association Functional Class | 12 months | |
Other | Change in 6-minute walk test | 12 months | ||
Other | Change in ergospirometry test | 12 months | ||
Other | Change in natriuretic peptide values | BNP and NT-proBNP | 12 months | |
Other | Change in left ventricular ejection fraction | 12 months | ||
Other | Change in QRS complex | Duration of the QRS complex, defined as the widest paced QRS complex rated at 12-lead ECG, measured immediately after the index procedure | ||
Other | Procedure time | The duration of the procedure (in minutes) measured immediately after the index procedure | ||
Other | Time to composite endpoint of cardiovascular death or hospitalization for heart failure | 12 months | ||
Other | Primary Outcome Measure in the Per-Protocol Population | Non-inferiority of clinical benefit, a hierarchical composite of all-cause death, any hospitalization for heart failure, any urgent heart failure visit, and left ventricular ejection fraction change at 12 months in the per-protocol population.
The category of clinical benefit of each patient will be determined by assessing the following criteria sequentially, stopping when the event is present: All-cause death: death during follow-up. Hospitalization for heart failure: any hospitalization for heart failure during follow-up. Urgent heart failure visit: any urgent heart failure visit during follow-up. Left ventricular ejection fraction change: the difference between baseline and follow-up, categorized by every 5-point change. The distribution of clinical benefit categories will be compared by ordinal distribution analysis. Non-inferiority margin: odds ratio <1.2. |
12 months | |
Other | Left ventricular activation time | 12 months | ||
Primary | Primary Outcome Measure | Non-inferiority of clinical benefit, a hierarchical composite of all-cause death, any hospitalization for heart failure, any urgent heart failure visit, and left ventricular ejection fraction change at 12 months.
The category of clinical benefit of each patient will be determined by assessing the following criteria sequentially, stopping when the event is present: All-cause death: death during follow-up. Hospitalization for heart failure: any hospitalization for heart failure during follow-up. Urgent heart failure visit: any urgent heart failure visit during follow-up. Left ventricular ejection fraction change: the difference between baseline and follow-up, categorized by every 5-point change. The distribution of clinical benefit categories will be compared by ordinal distribution analysis. Non-inferiority margin: odds ratio <1.2. |
12 months | |
Secondary | Key secondary outcome: Cost-effectiveness analysis (dominance) (superiority) | Time-Driven Activity-Based Costing analysis to assess cost-effectiveness of the intervention. | 12 months | |
Secondary | Time to composite endpoint of all-cause death, hospitalization for heart failure, or urgent heart failure visit | 12 months |
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