Clinical trial NCT03215849: Pacing in Heart Failure With Preserved LVEF
Official title: The Effect of Biventricular Pacing in Heart Failure With Preserved Left Ventricular Ejection Fraction: A Pilot Mechanistic Analysis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Heart Failure
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
Collaborators: name: Norfolk and Norwich University Hospitals NHS Foundation Trust
name: Cardiff Metropolitan University
First posted: 2017-07-12
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A random-order cross-over pilot trial of a CE marked device (pacemaker) outside its current intended purposes.

The study will comprise 10 patients. Recruitment of patients will take place from The University Hospital of Wales (Cardiff \& Vale University Health Board \[CVUHB\]). All patients recruited will have septal flattening during exercise demonstrated using contrast stress (exercise) echocardiography.

All 10 patients will be implanted with a CRT-pacemaker device and will be tested on all three of the following settings on separate visits (with a gap of up to 5 days between visits) in random order:

Routine Medical Therapy Routine Medical Therapy + LVP Routine Medical Therapy + BiVP


Eligibility criteria: Inclusion Criteria:

1. Clinical features consistent with heart failure. All patients will have symptoms of moderate to severe heart failure with New York Heart Association (NHYA) classification III or IV symptoms (for at least 3 months).
2. LV Ejection Fraction less or equal to 50%, with no evidence of significant valvular disease, no hypertrophic or restrictive cardiomyopathy, and no evidence of pericardial constriction.
3. Additionally all patients will have demonstrated evidence of septal flattening during exercise using contrast echocardiography.
4. Adults (over 18 years)
5. Negative test for Covid during surgical pre-assessment, and adherence to prescribed self-isolation before implantation.
6. Two weeks or more following final dose of vaccination against coronavirus.

Exclusion Criteria:

1. Inability to provide informed consent.
2. Enrolment in other clinical studies.
3. BMI more than 35
4. Objective evidence of significant lung disease on formal lung function testing
5. Previous (within three months) or scheduled coronary revascularisation or other cardiac surgery
6. Acute coronary syndrome (within the previous three months)
7. History of atrial fibrillation (AF)
8. Renal insufficiency requiring haemodialysis
9. Life expectancy less than 6 months
10. Prosthetic heart valves
11. Blood coagulation disorders
12. Immunocompromised patients (e.g. AIDS, patients on steroids, cytotoxic drugs, and radiation therapy)
13. Currently pregnant, or intending to conceive.
14. Recent positive Covid test (up to 14 days prior to pre-assessment).

Primary outcomes:
measure: Change in septal radius of curvature (corrected for LV area) between rest and peak exercise on stress echocardiography across the three pacing states.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in LV area between rest and exercise across the three pacing states
timeFrame: 12 weeks
measure: Change in Systolic and Diastolic mechanical Dyssynchrony Assessment on echocardiography across the three pacing states
timeFrame: 12 weeks
measure: Change in rest and exercise E/E' on echocardiography across the three pacing states
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: University Hospital Wales
Study officials:
affiliation: Cardiff and Vale University Health Board
name: Zaheer Yousef
role: PRINCIPAL_INVESTIGATOR
References: