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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Increasing the pacemaker lower rate
DeviceIncreasing the pacemaker lower rate from 60 to 80 bpm
Standard setting
DeviceLower rate setting of 60 bpm
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: 80 bpmActive comparator 1 intervention
Group B: 60 bpmOther 1 intervention
Trial outcomes
Primary outcomes
1
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
The MLHFQ is a validated patient-reported outcome assessing heart failure-related quality of life. It consists of 21 items scored 0-5, yielding a total score range of 0-105. Higher scores indicate worse quality of life. MLHFQ is collected at Visits 1-4.
Time frame
End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)Secondary outcomes
1
Distance walked during the 6-Minute Walk Test (6MWT)
The 6-Minute Walk Test measures the distance walked in meters during six minutes on a flat, hard surface. The distance walked ranges from 0 meters upward, with higher distances indicating better functional capacity. The 6MWT is performed at Visits 1-4.
Time frame
End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)2
Levels of N-terminal pro-B-type Natriuretic Peptide (NT-proBNP)
NT-proBNP is a circulating biomarker of myocardial wall stress and heart failure severity. It is measured in pg/mL. Higher concentrations indicate worse cardiac function. NT-proBNP is assessed at Visits 1-4.
Time frame
End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)3
New York Heart Association (NYHA) Functional Class
NYHA functional class is a measure of heart failure severity ranging from Class I to Class IV, with higher class indicating worse functional status. NYHA class is assessed at Visits 1-4.
Time frame
End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)4
National Amyloidosis Centre (NAC) Stage
National Amyloidosis Centre (NAC) stage is a prognostic staging system for transthyretin cardiac amyloidosis based on cardiac biomarkers. It is categorized as Stage I, II, or III, with higher stage indicating more advanced disease. NAC stage is assessed at Visits 1-4.
Time frame
End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)Other outcomes
1
Number of participants with hospitalization or urgent outpatient visit for heart failure
This outcome captures heart failure-related hospitalizations or urgent outpatient visits occurring during each treatment period.
Time frame
During each treatment period (approximately 3 months per period)2
Daily loop diuretic dose
Daily loop diuretic dose is recorded as milligrams per day. Higher doses indicate greater diuretic requirement. Loop diuretic dosing is assessed at Visits 1-4.
Time frame
End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)3
Number of participants with cardiac death
Cardiac death is defined as death resulting from cardiovascular causes, including heart failure, arrhythmia, or sudden cardiac death, as assessed by the site investigator.
Time frame
Through study completion (up to approximately 7 months)4
Left Ventricular Ejection Fraction (LVEF)
Left ventricular ejection fraction (LVEF) is expressed as a percentage (%). Higher values indicate better systolic function. LVEF is assessed by echocardiography at Visits 1-4.
Time frame
End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)Sponsors and contacts
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Source ClinicalTrials.gov
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