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Heart Failure Preserved Ejection FractionNCT06467266

Mechanistic Insights From Temporary Pacing in HFpEF

A study testing Acute Haemodynamic Study in people with Heart Failure Preserved Ejection Fraction and Pacing, run by Guy's and St Thomas' NHS Foundation Trust.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Heart failure with preserved ejection fraction (HFpEF) is characterised by impaired diastolic function. A recent clinical trial has demonstrated multiple beneficial outcomes in HFpEF patients receiving personalised accelerated pacing from indwelling permanent pacemakers, including symptomatic improvement, objective… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Acute Haemodynamic Study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
1 Jul 2024to 31 Oct 2026
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Formal diagnosis of HFpEF as per ESC guidelines
  • NYHA grade II-IV heart failure symptoms
  • LVEF ≥50%
  • Female participants of child-bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
  • Able (in the Investigators opinion) and willing to comply with all study requirements.
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Who cannot join

  • History of persistent or permanent AF
  • Permanent pacing device in situ
  • Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
  • Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
  • Participant who is terminally ill
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Show all 13Show fewer
  • Significant peripheral vascular disease precluding an EP study
  • A contraindication to anticoagulation
  • A prosthetic aortic, mitral or tricuspid valve
  • Significant Aortic valve disease
  • Known LV thrombus
  • Insufficient capacity to consent to the study
  • Participation in other studies with active treatment / investigational arm to avoid bias

Trial locations and contacts

No sites are listed yet.

Prof Christopher Aldo Rinaldi, MD, MBBS, FRCP, FHRS contact

0207188 7188

aldo.rinaldi@gstt.nhs.uk

Dr Sandra Howell, MBBS, MSc, MSc contact

0207188 7188

sandra.howell@kcl.ac.uk

About this study

Official title: Mechanistic Insights From Multisite Pacing in Patients With Heart Failure With Preserved Ejection Fraction

Heart failure with preserved ejection fraction (HFpEF) is characterised by impaired diastolic function. A recent clinical trial has demonstrated multiple beneficial outcomes in HFpEF patients receiving personalised accelerated pacing from indwelling permanent pacemakers, including symptomatic improvement, objective reductions in NT-proBNP level and AF-burden.

The investigators aim to determine the underlying mechanisms behind these documented effects, to investigate the acute intracardiac haemodynamic response to temporary multisite pacing in HFpEF participants and to gain further mechanistic insight with additional haemodynamic, electrical and echocardiographic data collection during temporary pacing in this cohort. This will all provide valuable information towards new potential targets of therapy.

Read the detailed description

In this research study, the investigators will perform a one-off temporary pacing procedure in the catheter lab at St Thomas' Hospital in patients with heart failure with preserved ejection fraction (HFpEF). During the short procedure, the investigators will pace the heart at different heart rates and from different parts of the heart. The investigators will measure the change in pressure inside the heart in response to each pacing site/mode and rate. Altogether, the investigators aim to find out how different pacing modes and heart rates impact how well the heart fills and pumps in HFpEF.

The study will provide valuable information about the underlying mechanisms of pacing in HFpEF, which could significantly influence the future direction of HFpEF management. Specifically, it will help the investigators to understand what types of pacemaker and pacing site or pacing mode may be chosen in HFpEF patients requiring pacing, which accounts for around 20% of all HFpEF patients.

Being tested
Acute Haemodynamic Study
Medical subject headings
Heart Failure, Diastolic

What participants receive

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

  • Acute Haemodynamic StudyDiagnostic test

    Multisite temporary pacing

Study groups in NCT06467266
Study groupRoleWhat they receive
InterventionExperimentalPatients will undergo cardiac imaging with a cardiac MRI and echocardiogram prior to the haemodynamic study. The haemdynamic study will be performed in the catheter lab. During that study patients will undergo a temporary pacing procedure with pacing of multiple sites of the heart and multiple haemodynamic recordings. This will be conducted under local anaesthetic and sedation. Total procedure time will be approximately 2 hours.
Receives: Diagnostic Test: Acute Haemodynamic Study

What is being measured

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

  1. Number of participants with changes in left ventricular end diastolic pressure upon accelerated right atrial pacing and conduction system pacing

    Measurement of the absolute left ventricular end diastolic pressure (in mmHg) and volume (in milliliter) at real-time during each pacing mode, heart rate and AV delay with a pressure volume loop catheter

    Measured: 30 months

Secondary outcomes (2)

  1. Number of participants with leftward, downward shift in the LV P-V loop during accelerated RA pacing and CSP, not reproduced by RV pacing

    Qualitative assessment of the leftward, downward shift in the left ventricular P-V loop during accelerated right atrial pacing and conduction system pacing, not reproduced by right ventricular pacing

    Measured: 30 months

  2. Number of participants with changes in Echo measures of diastology upon right atrial pacing and conduction system pacing

    Measurement of the absolute left ventricular tissue velocity (measured in centimeter/second) with the use of a pulse wave tissue doppler imaging (TDI) signal in the apical four chamber view

    Measured: 30 months

Timeline

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

  1. First posted20 Jun 2024
  2. Study start1 Jul 2024 (estimated)
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
This is an observational cohort mechanistic study.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06467266
Sponsor's protocol ID
332571
Status last verified
Jun 2024
First submitted
5 Jun 2024
Last updated
20 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Infeld M, Wahlberg K, Cicero J, Plante TB, Meagher S, Novelli A, Habel N, Krishnan AM, Silverman DN, LeWinter MM, Lustgarten DL, Meyer M. Effect of Personalized Accelerated Pacing on Quality of Life, Physical Activity, and Atrial Fibrillation in Patients With Preclinical and Overt Heart Failure With Preserved Ejection Fraction: The myPACE Randomized Clinical Trial. JAMA Cardiol. 2023 Mar 1;8(3):213-221. doi: 10.1001/jamacardio.2022.5320.

    PubMed 36723919

  • McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.

    PubMed 34447992

  • Reddy YNV, Koepp KE, Carter R, Win S, Jain CC, Olson TP, Johnson BD, Rea R, Redfield MM, Borlaug BA. Rate-Adaptive Atrial Pacing for Heart Failure With Preserved Ejection Fraction: The RAPID-HF Randomized Clinical Trial. JAMA. 2023 Mar 14;329(10):801-809. doi: 10.1001/jama.2023.0675.

    PubMed 36871285

  • Elliott MK, Strocchi M, Sieniewicz BJ, Sidhu B, Mehta V, Wijesuriya N, Behar JM, Thorpe A, Martic D, Wong T, Niederer S, Rinaldi CA. Biventricular endocardial pacing and left bundle branch area pacing for cardiac resynchronization: Mechanistic insights from electrocardiographic imaging, acute hemodynamic response, and magnetic resonance imaging. Heart Rhythm. 2023 Feb;20(2):207-216. doi: 10.1016/j.hrthm.2022.10.019. Epub 2022 Oct 28.

    PubMed 36575808

  • Dunlay SM, Roger VL, Redfield MM. Epidemiology of heart failure with preserved ejection fraction. Nat Rev Cardiol. 2017 Oct;14(10):591-602. doi: 10.1038/nrcardio.2017.65. Epub 2017 May 11.

    PubMed 28492288

Questions about this trial

What is this clinical trial studying?

A study testing Acute Haemodynamic Study in people with Heart Failure Preserved Ejection Fraction and Pacing, run by Guy's and St Thomas' NHS Foundation Trust.

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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Prof Christopher Aldo Rinaldi, MD, MBBS, FRCP, FHRS (0207188 7188, aldo.rinaldi@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with changes in left ventricular end diastolic pressure upon accelerated right atrial pacing and conduction system pacing (time frame: 30 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 NCT06467266, which also lists 5 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 20 Jun 2024.

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