Cardiac AmyloidosisNCT07583823
Elevated Rate Pacing of Cardiac Amyloidosis
A study testing Pacemaker Rate in people with Cardiac Amyloidosis and Pacemaker, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis, Pacemaker
- What is being tested?
- Pacemaker Rate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2025to 10 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Paced QRS duration of >150 ms (indicator for pacing mediated dyssynchrony)
- Dilated left ventricle
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Meghan Muscala, 612-626-5863, payne324@umn.edu
About this study
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.
- Conditions
- Cardiac Amyloidosis, Pacemaker
- Being tested
- Pacemaker Rate
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker RateOther
CA clinic patients with pacemakers will receive a personalized pacing protocol individual to their height and left ventricular ejection fraction.
| Study group | Role | What they receive |
|---|---|---|
| Elevated Pacemaker Rate | Experimental | CA clinic patients with pacemakers will receive a personalized pacing protocol individual to their height and left ventricular ejection fraction. Receives: Other: Pacemaker Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kansas City Cardiomyopathy Questionnaire Score
75-100 representing good to excellent health, and 0-24 representing very poor to poor health
Measured: Month 4
Composite of any cardiovascular event
admission or urgent visit for heart failure and atrial fibrillation, myocardial infarction or stroke
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start10 Oct 2025
- Primary completion10 Nov 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valmiki Maharaj, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583823
- Sponsor's protocol ID
- CV-2025-33753
- Status last verified
- Oct 2026
- First submitted
- 6 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes