NCT03338374: PREFECTUS

Cardiac Resynchronisation Therapy Versus Rate-responsive Pacing in Heart Failure With Preserved Ejection Fraction

Completed NA Last updated 2 June 2023

What this trial tests

NA trial testing Biventricular pacemaker in Diastolic Heart Failure in 10 participants. Completed in 30 May 2022.

Timeline

27 November 2017

Primary endpoint
30 May 2022

30 May 2022

Quick facts

Lead sponsor	Cardiff and Vale University Health Board
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	27 November 2017
Primary completion	30 May 2022
Estimated completion	30 May 2022
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Biventricular pacemaker

Conditions studied

• Diastolic Heart Failure — all drugs for Diastolic Heart Failure →

Sponsor

Cardiff and Vale University Health Board

Who can join

18 and older, any sex, with Diastolic Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Half of patients with heart failure have normal heart pumping function (Heart failure with Preserved Ejection Fraction, HFpEF), most commonly characterised by breathlessness on exercise. A number of mechanisms are responsible, but frequently patients are unable to raise their heart rate on exercise. This can be treated by a 'rate-responsive pacemaker' (RRP), which detects exercise and increases the heart rate accordingly. Some beneficial effects on echocardiographic parameters have been reported with exercise programmes. However, evidence based treatment options are limited in this group and therapy mainly relies on water tablets and treatment of blood pressure.

Cardiac resynchronisation therapy (CRT) is a technique using specialised 'biventricular' pacemakers that is well established in heart failure with reduced pump function. Patients who respond to this treatment have lower risk of death and hospitalisation and usually feel better. CRT is not currently used in HFpEF. The PROSPECT trial showed that some patients with relatively preserved heart function exhibited similar benefits to those with poor pump function, but this has not been formally tested. CRT aims to make the heart beat in a more synchronised way. Patients with HFpEF commonly have evidence of reduced heart synchronisation.

The investigators plan to assess the feasibility of using a prospective cohort study to assess the incremental benefit of CRT over and above RRP in patients with HFpEF. 10 patients with HFpEF and insufficient heart rate will be recruited and will undergo exercise testing, heart scanning and symptom questionnaires. A biventricular pacemaker will be implanted and programmed to RRP for 12 weeks before repeating the tests. After this, the investigators will non-invasively programme the pacemaker to CRT for 12 weeks and repeat the functional tests. If incremental benefit is shown with CRT the echocardiograms will be analysed in detail to determine the mechanism of change. The study participants will be invited to continue their involvement in a study extension. This will involve non-invasively programming the pacemakers to optimise their function guided by the results of the echocardiograms in the first two phases of the study. After a further 12 weeks, the functional assessments will be repeated. If no benefit is seen with CRT after initial analysis, the participant involvement will end.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic approaches in heart failure with preserved ejection fraction: past, present, and future.
   Wintrich J, Kindermann I, Ukena C, Selejan S, et al · · 2020 · cited 76× · PMID 32236720 · DOI 10.1007/s00392-020-01633-w
2. Rate-Adaptive Pacing for Heart Failure With Preserved Ejection Fraction.
   Kitzman DW, Upadhya B, Pandey A. · · 2023 · cited 3× · PMID 36871286 · DOI 10.1001/jama.2023.1053
3. Phenotype characterization of heart failure with preserved ejection fraction in medical device and surgical trials.
   Araz K, Fioretti F, Ladak S, Obaidan M, et al · · 2025 · cited 1× · PMID 40857067 · DOI 10.1002/ehf2.15401
4. New Opportunities in Heart Failure with Preserved Ejection Fraction: From Bench to Bedside… and Back.
   Parra-Lucares A, Romero-Hernández E, Villa E, Weitz-Muñoz S, et al · · 2022 · cited 1× · PMID 36672578 · DOI 10.3390/biomedicines11010070