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Could a faster pacemaker setting help heart amyloidosis patients feel better?

NCT ID NCT07413081

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether increasing the pacemaker's lower rate from 60 to 80 beats per minute improves quality of life and daily function in people with ATTR cardiac amyloidosis. The heart in this condition is stiff and depends on a faster heart rate to pump blood. Thirty-four participants will try both settings in a crossover design to see which works better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pacemaker rate adjustment
What this could lead to
If it works, this could point toward a simple way to improve daily function and well-being for people with cardiac amyloidosis who have a pacemaker.
What could go wrong
This is a small, early-stage trial with only 34 participants, so results may not apply to everyone. The benefit seen in similar conditions may not hold true for amyloidosis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Amyloid Neuropathies, Familial amyloidosis wild type ATTR amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, Denmark

  • Academic University Hospital

    Uppsala, Sweden

  • Karolinska University Hospital

    Stockholm, Sweden

  • Linköping University Hospital

    Linköping, Sweden

  • Norrland University Hospital

    Umeå, Sweden

  • Rigshospitalet

    Copenhagen, Denmark

  • Sahlgrenska University Hospital

    Gothenburg, Sweden

  • Skane University Hospital

    Lund, Sweden

  • Skellefteå Hospital

    Skellefteå, Sweden

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