Optimising Pacing for Contractility 2

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Leeds

About this trial

The investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF). They have also demonstrated in an acute cross-over and a small parallel group feasibility study that keeping the heart rate in this range (versus standard rate-response programming) in patients with CHF is associated with increased exercise time on a treadmill (around 60s or 10%). They now want to explore in a randomised, placebo-controlled 3-arm parallel group trial whether optimal programming versus standard rate-response programming versus no rate-response programming for 6 months leads to appreciable improvements in exercise time and quality of life, while having no adverse effects on left ventricular function and battery longevity and what the mechanisms of this might be.

450 patients with CHF and a pacemaker will undergo the non-invasive echocardiographic assessment to establish the force frequency relationship and the optimal heart rate for contractility. They will then perform a treadmill walk test, complete quality of life questionnaires and be offered the opportunity to participate in a series of mechanistic substudies. They will then be randomised to optimal rate-response settings, standard rate response settings or no rate-response settings and followed up at 6 months at which point the tests will be repeated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical, echocardiographic and neurohormonal evidence of heart failure

Cardiac pacemaker,

Able to perform a peak exercise test,

Willing and able to give informed consent.

Disqualifiers

Angina pectoris symptoms limiting exercise tolerance,

Unstable heart failure symptoms (medical therapy changes in last three months), Poor image quality,

Calcium channel blockers (CCBs).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Heart rate optimisation using force frequency data

    Device

    Programming heart rate rise according to the force frequency relationship

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: Standard rate-response settingsNo intervention 0 interventions
Group B: Rate-response settings offActive comparator 1 intervention
Group C: Optimized rate-response settingsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treadmill walk time

Time walked during a standard incremental treadmill test

Time frame
6 months

Secondary outcomes

1

Quality of life 1

EQ5D-5L score

Time frame
6 months
2

Quality of life 2

KCCQ score

Time frame
6 months
3

Clinical composite score

Clinical outcomes combined (death, hospitalisation, NYHA symptom level, diuretic dose

Time frame
6 months
4

Cardiac function during exercise measured by LVEF on echocardiogrpahy

As assessed on a cycle ergometer

Time frame
6 months

Other outcomes

Sponsors and contacts

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