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NCT Number: NCT06467266

Mechanistic Insights From Temporary Pacing in HFpEF

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

Acute Haemodynamic Study

Diagnostic Test

Multisite temporary pacing

Primary outcomes

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

    Time frame: 30 months

    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

Secondary outcomes

  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

    Time frame: 30 months

    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

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

    Time frame: 30 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Sandra Howell, MBBS, MSc, MSc

CONTACT

[email protected]

0207188 7188

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

CONTACT

[email protected]

0207188 7188

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 20, 2024
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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