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Heart FailurePhysioSync-HFNCT05572736

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

A study testing Conduction system pacing and Biventricular pacing in people with Heart Failure and Left Bundle-Branch Block, run by Hospital Moinhos de Vento at 14 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Conduction system pacing and Biventricular pacing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
14 sitesBrazil
Study dates
7 Nov 2022to 10 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Brazil14 sites

  • Hospital Geral Universitário de Cuiabá

    Cuiabá, Mato Grosso, 78020-840

  • SOS Cardio

    Florianópolis, Santa Catarina, 88030-000

  • Fundação Hospital do Coração Francisca Mendes

    Manaus, Amazonas, 69097720

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-000

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Mãe de Deus

    Porto Alegre, Rio Grande do Sul, 900880-481

  • Instituto de Medicina Integral Professor Fernando Figueira

    Recife, Pernambuco, 50070-902

  • Instituto Nacional de Cardiologia

    Rio de Janeiro, 22240-006

  • Hospital Ana Nery

    Salvador, Estado de Bahia, 40301-155

  • Instituto de Cardiologia de Santa Catarina

    São José, Santa Catarina, 88103-901

  • Beneficência Portuguesa

    São Paulo, 01323-001

  • Hospital Alemão Oswaldo Cruz

    São Paulo, 01323-020

  • Hospital Universitário da Universidade Federal do Piauí

    Teresina, Piauí, 64049-550

  • Hospital Universitário Cassiano Antônio de Moraes

    Vitória, Espírito Santo, 29041-295

Other trials in Brazil

About this study

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

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.

Being tested
Conduction system pacing, Biventricular pacing
Medical subject headings
Heart Failure, Bundle-Branch Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conduction system pacingDevice

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

  • Biventricular pacingDevice

    Pacing from the coronary sinus and right ventricular leads.

Study groups in NCT05572736
Study groupRoleWhat they receive
Conduction system pacingExperimentalPatients will be randomized 1:1 to either conduction system pacing or biventricular pacing.
Receives: Device: Conduction system pacing
Biventricular pacingActive comparatorPatients will be randomized 1:1 to either conduction system pacing or biventricular pacing.
Receives: Device: Biventricular pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome Measure

    Heart failure-related net composite outcome, 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 the composite outcome for 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 outcome categories will be compared by ordinal distribution analysis. Non-inferiority margin: odds ratio <1.2.

    Measured: 12 months

Secondary outcomes (10)

  1. Key secondary outcome: Cost analysis (dominance) (superiority)

    Mean total direct medical cost per patient at 12 months.

    Measured: 12 months

  2. Change in QRS complex

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

  3. Change in left ventricular ejection fraction

    Measured: 12 months

  4. Left ventricular end-diastolic volume

    Measured: 12 months

  5. Change in natriuretic peptide values

    BNP and NT-proBNP

    Measured: 12 months

  6. Change in 6-minute walk test

    Measured: 12 months

  7. Change in NYHA Classification

    New York Heart Association Functional Class

    Measured: 12 months

  8. 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.

    Measured: 12 months

  9. EuroQol Group 5-Dimensions questionnaire (EQ-5D)

    Measured: 12 months

  10. Hierarchical endpoint of death, hospitalization for heart failure, urgent heart failure visit, and change in KCCQ Clinical Summary Score

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2022
  2. Study start7 Nov 2022
  3. Primary completion10 Jan 2025
  4. Study completion10 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05572736
Sponsor's protocol ID
NUP: 25000.123471/2021-59
Acronym
PhysioSync-HF
Status last verified
Jun 2025
First submitted
2 Sep 2022
Last updated
8 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Zimerman A, Dal Forno A, Rohde LE, Ternes CM, Alves FD, Damiani LP, Martinelli-Filho M, Costa R, Fagundes AA, Barbosa RM, Gadelha EB, Lima CE, Silva MA, Maldonado JA, de Oliveira JC, Mallmann F, Baggio Junior JM, Duarte CE, de Souza LA, Santos JS, Silveira AD, Decker SRR, Zimerman LI, Polanczyk CA, d'Avila A. Conduction System vs Biventricular Pacing in Heart Failure: The PhysioSync-HF Randomized Clinical Trial. JAMA Cardiol. 2026 Apr 1;11(4):360-368. doi: 10.1001/jamacardio.2026.0101.

    PubMed 41811324

  • Decker SRR, Etges APBDS, Zimerman A, Alves FD, Ternes CM, Santos JS, Zimerman L, Rohde LE, Forno AD, d'Avila A, Kazi DS, Bertoldi EG, Polanczyk CA. Conduction System Pacing vs Biventricular Pacing in Chronic Heart Failure: Protocol for the Economic Analysis of the PhysioSync-HF Trial. Arq Bras Cardiol. 2025 Dec;122(12):e20250254. doi: 10.36660/abc.20250254. English, Portuguese.

    PubMed 41779515

  • Zimerman A, Dal Forno A, Rohde LE, Ternes CM, Alves FD, Decker SR, Silveira AD, Damiani LP, Martinelli Filho M, Costa R, Fagundes AA, Barbosa RM, Gadelha EB, Lima CE, Silva MA, Maldonado JA, de Oliveira JC, Mallmann F, Baggio JM Jr, Duarte CE, Zimerman LI, D'Avila A, Polanczyk CA. Conduction system pacing vs biventricular resynchronization in heart failure with reduced ejection fraction and left bundle branch block: Rationale and design of the PhysioSync-HF Trial. Am Heart J. 2025 Dec;290:38-45. doi: 10.1016/j.ahj.2025.06.002. Epub 2025 Jun 3.

    PubMed 40473010

Questions about this trial

What is this clinical trial studying?

A study testing Conduction system pacing and Biventricular pacing in people with Heart Failure and Left Bundle-Branch Block, run by Hospital Moinhos de Vento at 14 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome Measure (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05572736, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.

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PhysioSync-HF Clinical Trial NCT05572736 | AzTrials