Increased Pacemaker Lower Rate in ATTR Cardiac Amyloidosis

NCT07413081 | Not Yet Recruiting

• 1 other identifier: 2025-07764-01
• Study Type: interventional
• Target: 34
• Locations: 2 countries
• Sites: 9

Brief Summary

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.

Conditions

Cardiac Amyloidosis; Pacemaker

Outcome Measures

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.

  End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)

Secondary Outcomes (8)

• Distance walked during the 6-Minute Walk Test (6MWT)

  End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)

• Levels of N-terminal pro-B-type Natriuretic Peptide (NT-proBNP)

  End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)

• New York Heart Association (NYHA) Functional Class

  End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)

• National Amyloidosis Centre (NAC) Stage

  End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)

• Number of participants with hospitalization or urgent outpatient visit for atrial fibrillation

  During each treatment period (approximately 3 months per period)

Other Outcomes (4)

• Number of participants with hospitalization or urgent outpatient visit for heart failure

  During each treatment period (approximately 3 months per period)

• Daily loop diuretic dose

  End of each treatment period (Visit 2 at approximately 3 months and Visit 4 at approximately 7 months)

• Number of participants with cardiac death

  Through study completion (up to approximately 7 months)

Study Arms (2)

80 bpm

ACTIVE COMPARATOR

Device: Increasing the pacemaker lower rate

60 bpm

OTHER

Device: Standard setting

Interventions

Increasing the pacemaker lower rate DEVICE

Increasing the pacemaker lower rate from 60 to 80 bpm

80 bpm

Standard setting DEVICE

Lower rate setting of 60 bpm

60 bpm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ATTR-CM defined as one of the following:
• 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.
• NYHA functional class II-III
• Pre-existing pacemaker and either:
• a.Atrial pacing with minimal RV pacing (\<2%), or
• b.His bundle or left bundle branch area pacing, or
• c.Biventricular pacing, or
• d.Ongoing RV pacing with a high degree of RV pace (\>80%)
• NT-proBNP \>600 ng/L
• Age ≥18 years
• Ability and willingness to provide written informed consent
• Pacing \>80% with a programmed lower rate of 60 (AAI/CSP/CRT/RV-pace)

You may not qualify if:

• 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.
• More than moderate valvular stenosis or regurgitation
• Inability of the patient, in the opinion of the investigator, to understand and/or comply with procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
• Presence of any other disease than heart failure with a life expectancy of \< 1year in the investigators opinion
• Enrollment in other interventional device or drug trials during the study period, with the exception of open label extension studies
• Listed for cardiac transplantation
• Initiation of SGLT2-inhibitor or mineralocorticoid receptor antagonist within 4 weeks prior to enrollment
• Initiation or change in loop diuretic therapy within 4 weeks prior to enrollment

Sponsors & Collaborators

• Region Skane: lead

Study Sites (9)

Aarhus University Hospital

Aarhus, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Linköping University Hospital

Linköping, Sweden

Location

Skane University Hospital

Lund, Sweden

Location

Skellefteå Hospital

Skellefteå, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Norrland University Hospital

Umeå, Sweden

Location

Academic University Hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Central Study Contacts

Arash Mokhtari, MD, PhD

CONTACT

+4646171000; arash.mokhtari.0561@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 17, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-01

Locations

SE (7); DK (2)