Clinical trial NCT05572736: Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure
Official title: Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure (PhysioSync-HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Left Bundle-Branch Block
Cardiac Resynchronization
Conduction System Pacing
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2022-10-10
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of conduction system pacing versus biventricular pacing in patients with chronic heart failure with reduced ejection fraction and left bundle branch block.


Eligibility criteria: 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

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: 12 months
Secondary outcomes:
measure: Key secondary outcome: Cost analysis (dominance) (superiority)
timeFrame: 12 months
measure: Change in QRS complex
timeFrame: Duration of the QRS complex, defined as the widest paced QRS complex rated at 12-lead ECG, measured immediately after the index procedure
measure: Change in left ventricular ejection fraction
timeFrame: 12 months
measure: Left ventricular end-diastolic volume
timeFrame: 12 months
measure: Change in natriuretic peptide values
timeFrame: 12 months
measure: Change in 6-minute walk test
timeFrame: 12 months
measure: Change in NYHA Classification
timeFrame: 12 months
measure: Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score
timeFrame: 12 months
measure: EuroQol Group 5-Dimensions questionnaire (EQ-5D)
timeFrame: 12 months
measure: Hierarchical endpoint of death, hospitalization for heart failure, urgent heart failure visit, and change in KCCQ Clinical Summary Score
timeFrame: 12 months
Other outcomes:
measure: Change in peak oxygen consumption (VO2)
timeFrame: 12 months
Locations:
city: Manaus
country: Brazil
facility: Fundação Hospital do Coração Francisca Mendes
state: Amazonas
city: Salvador
country: Brazil
facility: Hospital Ana Nery
state: Bahia
city: Vitória
country: Brazil
facility: Hospital Universitário Cassiano Antônio de Moraes
state: Espírito Santo
city: Cuiabá
country: Brazil
facility: Hospital Geral Universitário de Cuiabá
state: Mato Grosso
city: Recife
country: Brazil
facility: Instituto de Medicina Integral Professor Fernando Figueira
state: Pernambuco
city: Teresina
country: Brazil
facility: Hospital Universitário da Universidade Federal do Piauí
state: Piauí
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Mãe de Deus
state: Rio Grande Do Sul
city: Florianópolis
country: Brazil
facility: SOS Cardio
state: Santa Catarina
city: São José
country: Brazil
facility: Instituto de Cardiologia de Santa Catarina
state: Santa Catarina
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Cardiologia
city: São Paulo
country: Brazil
facility: Beneficência Portuguesa
city: São Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
Study officials:
affiliation: Hospital Moinhos de Vento
name: Carisi Polanczyk, MD PhD
role: STUDY_CHAIR
affiliation: Harvard Medical School (HMS and HSDM)
name: Andre d'Avila, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital SOS Cardio
name: Alexander Dal Forno, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Moinhos de Vento
name: Leandro Zimerman, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Moinhos de Vento
name: Luis E Rohde, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Moinhos de Vento
name: Andre Zimerman, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Moinhos de Vento
name: Caique Ternes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Moinhos de Vento
name: Fernanda D Alves, PhD
role: STUDY_DIRECTOR
References: