Pacing in Heart Failure With Preserved LVEF (MAPPLE)

Cardiff and Vale University Health Board

Status: Invitation-only

Conditions: Heart Failure

Treatments: Device: CRT-pacemaker device set to Routine Medical Therapy; Device: CRT-pacemaker device set to Routine Medical Therapy + BiVP; Device: CRT-pacemaker device set to Routine Medical Therapy + LVP

Study type: Interventional

Funder types: Other

Identifiers

NCT03215849

203878

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 3 patient groups

Routine Medical Therapy

Sham Comparator group

Description:

Routine Medical Therapy

Treatment:

Device: CRT-pacemaker device set to Routine Medical Therapy

Routine Medical Therapy + LVP

Experimental group

Description:

Routine Medical Therapy + LVP

Treatment:

Device: CRT-pacemaker device set to Routine Medical Therapy + LVP

Routine Medical Therapy + BiVP

Experimental group

Description:

Routine Medical Therapy + BiVP

Treatment:

Device: CRT-pacemaker device set to Routine Medical Therapy + BiVP