NCT07413081Not yet recruiting
Increased Pacemaker Lower Rate in ATTR Cardiac Amyloidosis
Increased Pacemaker Lower Rate in ATTR Cardiac Amyloidosis: a Randomized, Crossover Clinical Trial (PACE-ATTR)
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 20 Jan 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Region Skane
- Diseases
- Amyloidosis
- NCT number
- NCT07413081
What you commit to
- Study type: Interventional
- Planned participants: 34
- From 1 Feb 2026 to the primary completion date, 31 Dec 2027
- 9 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Enrollment in other interventional device or drug trials during the study period, with the exception of open label extension studies
- 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
Other illness
- 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.
- 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
- Listed for cardiac transplantation
Other
- Inability to perform the 6-minute walk test.
- Planned upgrade to CRT or conduction system pacing in patients with RV pacing.
- More than moderate valvular stenosis or regurgitation
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Linkoping University Hospital Coordinator of this site? Confirm its status | Linköping | Sweden | Unknown status |
| Skåne University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
| Skellefteå hospital Coordinator of this site? Confirm its status | Skellefteå | Sweden | Unknown status |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Norrland University Hospital Coordinator of this site? Confirm its status | Umeå | Sweden | Unknown status |
| Academic University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.