ClinicalTrials.gov record NCT07583823
Elevated Rate Pacing of Cardiac Amyloidosis
Elevated Rate Pacing of Cardiac Amyloidosis
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 interventional study enrolls a cohort of 10 people with cardiac amyloidosis who have implanted pacemakers. Participants will receive a personalized increase in their pacemaker's programmed rate based on height and left ventricular ejection fraction. The study compares symptoms, exercise tolerance, and a composite of cardiovascular events before and after rate elevation, with main outcomes assessed at month 4.
What it is studying. The study tests whether raising the programmed pacemaker rate in people with cardiac amyloidosis affects heart-failure symptoms, exercise tolerance, and a composite of cardiovascular events. Outcomes include the Kansas City Cardiomyopathy Questionnaire score and a composite of admissions or urgent visits for heart failure, atrial fibrillation, myocardial infarction, or stroke, measured at month 4.
What the researchers hope to learn. To quantify changes in patient-reported heart-failure health and exercise tolerance after pacemaker rate elevation and to record related cardiovascular events, informing supportive care for people with cardiac amyloidosis.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This study aims to better quantify the improvements in heart failure symptoms and exercise tolerance before and after the heart rate elevation in a cohort of 10 cardiac amyloidosis patients with preexisting pacemakers.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Pacemaker Rate
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Adults 18 and older
- Diagnosis of cardiac amyloidosis as indicated by the criteria set forth in guidelines such as in Kittleson et al: "2023 ACC Expert Consensus Decision Pathway on Comprehensive Multidisciplinary Care for the Patient With Cardiac Amyloidosis: A Report of the American College of Cardiology Solution Set Oversight Committee
- Implanted Cardiac Pacemaker (+/- Defibrillator)
- Pacemaker mode of AAI or DDD if in sinus rhythm, VVI acceptable if permanent atrial fibrillation
- Non-dilated left ventricle by echocardiography
- Ability to provide written consent
- English Speaking
Exclusion criteria
- Paced QRS duration of >150 ms (indicator for pacing mediated dyssynchrony)
- Dilated left ventricle
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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.
If you take part, study staff will program your existing pacemaker to a personalized, higher pacing rate determined by your height and left ventricular ejection fraction. The study will measure symptoms and outcomes, including the Kansas City Cardiomyopathy Questionnaire score and a composite of cardiovascular events (hospital admission or urgent visit for heart failure or atrial fibrillation, myocardial infarction, or stroke) at Month 4. The registry requires that you already have a diagnosis of cardiac amyloidosis, an implanted pacemaker, and an echocardiogram showing a non-dilated left ventricle; the record does not say the study performs those tests itself. The record does not describe other study procedures, visit schedule, or additional tests.
How the study is structured. Interventional, single-group, open-label study. All participants receive a personalized elevated pacemaker-rate protocol (individualized to height and left ventricular ejection fraction). Measures are taken before and after the rate change, with primary outcomes assessed at month 4. There is no separate control group and no masking.
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 listed sites are in United States. 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 ATTRv amyloidosis
This trial is also listed on this site under wild-type ATTR amyloidosis.
Important dates
- Study start
- Oct 10, 2025
- Primary completion
- Oct 10, 2026 (estimated)
- Study completion
- Oct 10, 2026 (estimated)
- Target enrollment
- 10 participants (estimated)
- Last updated on registry
- May 13, 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
- University of Minnesota
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.
- Meghan Muscala 📞 612-626-5863 ✉ payne324@umn.edu
Participating sites (1)
- University of MinnesotaRecruiting
Minneapolis, Minnesota, 55455 · United States
- Meghan Muscala · 612-626-5863 · payne324@umn.edu
Terms used on this page · explanations by MedicalUpdates.ai
- cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
- echocardiography
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
- 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.
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.
← Back to clinical trials