ClinicalTrials.gov record NCT07413081

Increased Pacemaker Lower Rate in ATTR Cardiac Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Increased Pacemaker Lower Rate in ATTR Cardiac Amyloidosis: a Randomized, Crossover Clinical Trial (PACE-ATTR)

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old and older
SexAll
LocationDenmark, Sweden
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized, double-masked crossover trial compares two pacemaker lower-rate settings (80 bpm versus 60 bpm) in people with transthyretin cardiac amyloidosis who already have a pacemaker. Each participant will spend about three months on one setting and three months on the other. The study looks at patient-reported quality of life and physical function, plus device-recorded activity and arrhythmia measures.

What it is studying. The study is testing whether increasing the pacemaker lower rate from the standard 60 beats per minute to 80 beats per minute changes health-related quality of life and functional capacity in people with transthyretin cardiac amyloidosis (ATTR-CM) who have a pacemaker. It also compares effects on walking distance, heart-failure biomarkers, atrial fibrillation burden, physical activity recorded by the pacemaker, and cardiac injury markers.

What the researchers hope to learn. To determine whether a higher pacemaker lower rate (80 bpm) changes patient-reported quality of life and functional capacity in ATTR-CM. To measure effects on walking distance, NT-proBNP levels, NYHA class, NAC staging, atrial fibrillation episodes and burden, pacemaker-recorded physical activity, and cardiac troponin levels.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device
  • Increasing the pacemaker lower rate
  • Standard setting

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Transthyretin amyloid cardiomyopathy (ATTR-CM) is an increasingly recognized cause of restrictive cardiomyopathy, characterized by reduced ventricular compliance, low stroke volume, and marked dependence on heart rate for maintenance of cardiac output. Conduction disease is common in ATTR-CM, and a substantial proportion of patients require permanent pacemaker implantation. Although disease-modifying therapy can slow disease progression, evidence guiding optimization of pacemaker therapy in ATTR-CM is lacking. In heart failure with preserved ejection fraction, a condition also characterized by reduced ventricular compliance, increased pacemaker lower rate settings have been shown to improve functional capacity and quality of life. However, patients with cardiac amyloidosis were excluded from these studies. Consequently, current practice in ATTR-CM relies largely on extrapolation and expert opinion. In this randomized multicenter 2×2 crossover trial, we aim to determine whether a higher pacemaker lower rate (80 bpm) improves health-related quality of life (QoL) and functional capacity in patients with ATTR-CM compared with the standard setting of 60 bpm.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have their pacemaker lower-rate setting programmed to two different settings (60 bpm and 80 bpm) in a randomized, double‑blind crossover with two treatment periods of about 3 months each. At study visits (start and end of each period) they will complete the Minnesota Living with Heart Failure Questionnaire, perform the 6‑minute walk test, undergo clinical assessments including NYHA class, and give blood samples for biomarkers (NT‑proBNP and high‑sensitivity troponin). Data from the implanted pacemaker (atrial fibrillation burden and device activity) will be collected during each treatment period. The main procedures are non‑invasive device programming, walking tests, questionnaires, clinic visits, and blood draws.

How the study is structured. Randomized, double-masked (participants and outcome assessors blinded), 2×2 crossover trial. Each participant will be assigned at random to start with either the higher lower-rate setting (80 bpm) or the standard setting (60 bpm), use that setting for about three months, then switch to the other setting for about three months. Outcomes are measured at the end of each treatment period.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Cardiac Amyloidosis; Pacemaker. Does it apply to my diagnosis?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Denmark, Sweden. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

This trial is also listed on this site under ATTRv amyloidosis.

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Feb 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Study completion
Dec 31, 2027 (estimated)
Target enrollment
34 participants (estimated)
Last updated on registry
Feb 17, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Region Skane

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (9)

Terms used on this page · explanations by MedicalUpdates.ai

biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
serum free light chain
Small pieces of antibody protein made by plasma cells and measured in a blood test. In some conditions, such as AL amyloidosis, abnormal free light chains are the source of the disease.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
6-minute walk test
A test of how far a person can walk on a flat surface in six minutes. It is used to measure stamina and to track change over time.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
open label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
crossover
Each participant receives more than one intervention, one after the other, usually with a gap (a washout) in between. Participants act as their own comparison.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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