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 will enroll about 10 people with cardiac amyloidosis who already have implanted pacemakers. Each participant will have their pacemaker programmed to a personalized higher heart rate. The study compares symptoms and exercise tolerance before and after the paced heart-rate change, with outcomes measured through four months.
What it is studying. The study tests whether a personalized increase in the programmed pacemaker rate changes heart-failure symptoms, exercise tolerance, quality-of-life (Kansas City Cardiomyopathy Questionnaire), and the occurrence of cardiovascular events over four months.
What the researchers hope to learn. To quantify changes in symptoms, exercise tolerance, patient-reported heart-failure status (KCCQ), and a composite of cardiovascular events after raising pacemaker rate in 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.
Participants will have their pacemaker reprogrammed to a personalized higher heart rate based on their height and left ventricular ejection fraction. They will complete baseline and follow-up assessments with key measurements at 4 months, including the Kansas City Cardiomyopathy Questionnaire and clinical monitoring for heart-related events (hospital or urgent visits for heart failure or atrial fibrillation, myocardial infarction, or stroke). Written consent and the ability to speak English are required.
How the study is structured. Single-group, open (not masked) interventional study. All participants receive a personalized pacemaker-rate protocol set by the study team (individualized to height and left ventricular ejection fraction). Participants are assessed before the rate change and followed for outcomes up to four months.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- 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 wild-type ATTR amyloidosis
This trial is also listed on this site under ATTRv 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.
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