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Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure (PhysioSync-HF)

Primary Purpose

Heart Failure, Left Bundle-Branch Block, Cardiac Resynchronization

Status

Recruiting

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Conduction system pacing

Biventricular pacing

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fundação Hospital do Coração Francisca MendesRecruiting
Hospital Ana NeryRecruiting
Hospital Universitário Cassiano Antônio de MoraesRecruiting
Hospital Geral Universitário de CuiabáRecruiting
Instituto de Medicina Integral Professor Fernando FigueiraRecruiting
Hospital Universitário da Universidade Federal do PiauíRecruiting
Hospital Moinhos de VentoRecruiting
Hospital de Clínicas de Porto AlegreRecruiting
Hospital Mãe de DeusRecruiting
SOS CardioRecruiting
Instituto de Cardiologia de Santa CatarinaRecruiting
Instituto Nacional de CardiologiaRecruiting
Beneficência PortuguesaRecruiting
Hospital Alemão Oswaldo CruzRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conduction system pacing

Biventricular pacing

Arm Description

Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Key secondary outcome: Cost-effectiveness analysis (dominance) (superiority)

Time-Driven Activity-Based Costing analysis to assess cost-effectiveness of the intervention.

Time to composite endpoint of all-cause death, hospitalization for heart failure, or urgent heart failure visit

Full Information

NCT ID

NCT05572736

First Posted

September 2, 2022

Last Updated

February 27, 2023

Sponsor

Hospital Moinhos de Vento

Collaborators

Ministry of Health, Brazil

1. Study Identification

Unique Protocol Identification Number

NCT05572736

Brief Title

Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure

Acronym

PhysioSync-HF

Official Title

Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure (PhysioSync-HF)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 7, 2022 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Moinhos de Vento

Collaborators

Ministry of Health, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Left Bundle-Branch Block, Cardiac Resynchronization, Conduction System Pacing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Conduction system pacing

Arm Type

Experimental

Arm Description

Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.

Arm Title

Biventricular pacing

Arm Type

Active Comparator

Arm Description

Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.

Intervention Type

Device

Intervention Name(s)

Conduction system pacing

Intervention Description

Pacing from the His-Purkinje system (His-bundle pacing, left bundle branch area pacing, or deep septal pacing).

Intervention Type

Device

Intervention Name(s)

Biventricular pacing

Intervention Description

Pacing from the coronary sinus and right ventricular leads.

Primary Outcome Measure Information:

Title

Primary Outcome Measure

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Key secondary outcome: Cost-effectiveness analysis (dominance) (superiority)

Description

Time-Driven Activity-Based Costing analysis to assess cost-effectiveness of the intervention.

Time Frame

12 months

Title

Time to composite endpoint of all-cause death, hospitalization for heart failure, or urgent heart failure visit

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score

Description

The Kansas City Cardiomyopathy Questionnaire Overall Summary Score ranges from 0-100, where a lower score indicates a worse outcome.

Time Frame

12 months

Title

Change in NYHA Classification

Description

New York Heart Association Functional Class

Time Frame

12 months

Title

Change in 6-minute walk test

Time Frame

12 months

Title

Change in natriuretic peptide values

Description

BNP and NT-proBNP

Time Frame

12 months

Title

Change in left ventricular ejection fraction

Time Frame

12 months

Title

Change in QRS complex

Time Frame

Duration of the QRS complex, defined as the widest paced QRS complex rated at 12-lead ECG, measured immediately after the index procedure

Title

Procedure time

Time Frame

The duration of the procedure (in minutes) measured immediately after the index procedure

Title

Time to composite endpoint of cardiovascular death or hospitalization for heart failure

Time Frame

12 months

Title

Primary Outcome Measure in the Per-Protocol Population

Description

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.

Time Frame

12 months

Title

Left ventricular activation time

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andre Zimerman, MD PhD

Phone

+55 51 99877-6668

zimerman.andre@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Caique Ternes, MD

Phone

+55 48 99190-9080

caiqueternes@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carisi Polanczyk, MD PhD

Organizational Affiliation

Hospital Moinhos de Vento

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Andre d'Avila, MD PhD

Organizational Affiliation

Harvard Medical School (HMS and HSDM)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alexander Dal Forno, MD

Organizational Affiliation

Hospital SOS Cardio

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Leandro Zimerman, MD PhD

Organizational Affiliation

Hospital Moinhos de Vento

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luis E Rohde, MD PhD

Organizational Affiliation

Hospital Moinhos de Vento

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Andre Zimerman, MD PhD

Organizational Affiliation

Harvard Medical School (HMS and HSDM)

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Caique Ternes, MD

Organizational Affiliation

Hospital de Clinicas de Porto Alegre

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Fabiano Barrionuevo, MD

Organizational Affiliation

Hospital Moinhos de Vento

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Fernanda D Alves, PhD

Organizational Affiliation

Hospital Moinhos de Vento

Official's Role

Study Director

Facility Information:

Facility Name

Fundação Hospital do Coração Francisca Mendes

City

Manaus

State/Province

Amazonas

ZIP/Postal Code

69097720

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vilma Lopes

Phone

5592991364049

First Name & Middle Initial & Last Name & Degree

Jaime Arnez, MD

Facility Name

Hospital Ana Nery

City

Salvador

State/Province

Bahia

ZIP/Postal Code

40301-155

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Renata

Phone

5571992548195

First Name & Middle Initial & Last Name & Degree

Alexandro A Fagundes, MD

Facility Name

Hospital Universitário Cassiano Antônio de Moraes

City

Vitória

State/Province

Espírito Santo

ZIP/Postal Code

29041-295

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Júlia Siman

Phone

5527997958395

First Name & Middle Initial & Last Name & Degree

Fernando Luiz T Gomes, MD

Facility Name

Hospital Geral Universitário de Cuiabá

City

Cuiabá

State/Province

Mato Grosso

ZIP/Postal Code

78020-840

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Samir Bissi

Phone

5565992018028

First Name & Middle Initial & Last Name & Degree

Julio Cesar Oliveira, MD

Facility Name

Instituto de Medicina Integral Professor Fernando Figueira

City

Recife

State/Province

Pernambuco

ZIP/Postal Code

50070-902

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nathalia Santos

Phone

5181992000763

First Name & Middle Initial & Last Name & Degree

Eduardo B Gadelha, MD

Facility Name

Hospital Universitário da Universidade Federal do Piauí

City

Teresina

State/Province

Piauí

ZIP/Postal Code

64049-550

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lyon Nascimento

Phone

5586995950645

First Name & Middle Initial & Last Name & Degree

Carlos Eduardo Lima, MD

Facility Name

Hospital Moinhos de Vento

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fernanda D Alves, PhD

Phone

5551996511153

First Name & Middle Initial & Last Name & Degree

Leandro Zimerman, MD, PhD

Facility Name

Hospital de Clínicas de Porto Alegre

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mauren Haeffner

Phone

5551991614514

First Name & Middle Initial & Last Name & Degree

Leandro Zimerman, MD

Facility Name

Hospital Mãe de Deus

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

900880-481

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen Brasil

Phone

5551981244624

First Name & Middle Initial & Last Name & Degree

Eduardo Bartholomay, MD

Facility Name

SOS Cardio

City

Florianópolis

State/Province

Santa Catarina

ZIP/Postal Code

88030-000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Grazyelle Damasceno

Phone

55489912348866

grazydamasceno@sinuscordis.com

First Name & Middle Initial & Last Name & Degree

Alexander Dal Forno, MD

Facility Name

Instituto de Cardiologia de Santa Catarina

City

São José

State/Province

Santa Catarina

ZIP/Postal Code

88103-901

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gabriel Odozynsky, MD

Phone

5549896248230

First Name & Middle Initial & Last Name & Degree

Fabricio Mallman, MD

Facility Name

Instituto Nacional de Cardiologia

City

Rio De Janeiro

ZIP/Postal Code

22240-006

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lisa Fialho

Phone

5521988059531

First Name & Middle Initial & Last Name & Degree

Rodrigo M Barbosa, MD

Facility Name

Beneficência Portuguesa

City

São Paulo

ZIP/Postal Code

01323-001

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luciene D de Jesus

Phone

5511985405456

First Name & Middle Initial & Last Name & Degree

Carlos Eduardo Duarte, MD

Facility Name

Hospital Alemão Oswaldo Cruz

City

São Paulo

ZIP/Postal Code

01323-020

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roberta de Souza

Phone

551135490399

First Name & Middle Initial & Last Name & Degree

Anisio Pedrosa, MD

12. IPD Sharing Statement

Plan to Share IPD

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Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure

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