Increased Pacemaker Lower Rate in ATTR Cardiac Amyloidosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
In cardiac amyloidosis, the heart muscle becomes thick and stiff, making it difficult to pump enough blood with each beat. The heart also often cannot increase its stroke volume, making patients with cardiac amyloidosis more dependent on having an adequate heart rate. Many develop conduction problems and need a pacemaker. In a related condition, heart failure with preserved ejection fraction, setting a higher pacemaker rate improved patients' quality of life. It is not known if the same benefits apply to amyloidosis. This study will test whether raising the pacemaker rate improves well-being and daily function in affected patients.
Eligibility criteria
Qualifiers
a.Positive cardiac biopsy for ATTR amyloidosis
b.Positive extra-cardiac biopsy for ATTR amyloidosis AND cardiac involvement demonstrated by CMR or echocardiography
c.Grade 2-3 uptake on DPD-scintigraphy AND negative serum free light chain and negative urine and serum immunofixation AND cardiac involvement demonstrated by CMR or echocardiography
Ongoing treatment with a transthyretin stabilizer or silencer OR considered not to be a candidate for these therapies with no planned initiation during the study period.
Disqualifiers
Inability to perform the 6-minute walk test.
Planned coronary revascularization, ablation of atrial flutter/fibrillation, or any severe (obstructive or regurgitant) valvular heart disease expected to require intervention during the trial in the investigator's opinion.
MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, cardioversion, valve repair/replacement, hospitalization for decompensated heart failure or cardiac resynchronisation therapy within 12 weeks prior to enrollment.
Planned upgrade to CRT or conduction system pacing in patients with RV pacing.
Trial design
Treatments tested in this trial
- Increasing the pacemaker lower rate
- Standard setting
Treatment groups
34 Participants
are divided into 2 treatment groupsLocations
9Denmark
Aarhus University Hospital Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Sweden
Sahlgrenska University Hospital Gothenburg Sweden
Linköping University Hospital Linköping Sweden
Sponsors and collaborators
Region Skane
Lead sponsor
Source ClinicalTrials.gov