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Mechanistic Insights From Temporary Pacing in HFpEF

ConditionsHeart Failure Preserved Ejection FractionPacing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuy's and St Thomas' NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Acute Haemodynamic Study

    Diagnostic test

    Multisite temporary pacing

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame
30 months

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

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

Time frame
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

Time frame
30 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guy's and St Thomas' NHS Foundation Trust

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: