Mechanistic Insights From Temporary Pacing in HFpEF

Launched by GUY'S AND ST THOMAS' NHS FOUNDATION TRUST · Jun 14, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how temporary pacing can help patients with heart failure and preserved ejection fraction (HFpEF). HFpEF is a condition where the heart has trouble relaxing and filling with blood, but it can still pump effectively. The trial aims to understand how personalized pacing from pacemakers can improve symptoms and heart function. Researchers want to explore the immediate effects of this pacing and gather more detailed information about heart performance during the procedure.

To be eligible for the trial, participants must be at least 18 years old and have a formal diagnosis of HFpEF with certain levels of heart function. They should be experiencing moderate to severe heart failure symptoms and be willing to follow the study's guidelines. Participants can expect to undergo temporary pacing to assess its effects on their heart, and their general health will be monitored closely throughout the study. This trial is not yet recruiting, but it hopes to shed light on new treatment options for HFpEF patients in the future.

Gender

ALL

Eligibility criteria

• 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