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NCT06332391 · ClinicalTrials.gov registry record · NA
Paced Heart Rate Acceleration for Cardiac Conditioning
A NA study of Heart Failure, Systolic, sponsored by Denice Hodgson-Zingman, MD.
- Recruiting
- Registry status
- NA
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT06332391 is a NA study of Heart Failure, Systolic that is actively recruiting participants, run by Denice Hodgson-Zingman, MD. The registered enrollment target is 52 participants, below the 332-participant average among 13 other Heart Failure, Systolic trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06332391, a NA study of Heart Failure, Systolic, is actively recruiting participants, sponsored by Denice Hodgson-Zingman, MD.
- RECRUITING
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
A clinical trial of exercise-similar heart rate acceleration delivered via cardiac pacing vs. sham intervention in subjects at rest will be performed. The study population comprises subjects with guideline-directed medically managed left ventricular dysfunction due to ischemic or non-ischemic cardiomyopathy and an existing implantable cardioverter defibrillator or biventricular implantable cardioverter defibrillator. The purpose of the study is to understand how the heart rate pattern of exercise contributes to the considerable cardiac conditioning effects of exercise and estimate whether the pacing approach may have translational clinical applicability. Fifty-two subjects will be randomized, single-blinded, to either the pacing intervention or a sham intervention which they will receive once daily, 3 days/week for 6 weeks. Baseline symptoms and clinical test results will be compared to the same measures at 2 weeks, 4 weeks and 6 weeks of intervention/sham and at 3 months and one-year post-intervention. The primary endpoint will be the change in left ventricular ejection fraction from baseline in intervention vs. sham groups (mixed effects linear regression with time and treatment arm as fixed effects and pre-specified covariates of sex and cardiomyopathy type as random effects). Secondary endpoints will include changes in quality of life, 6-minute walk distance, cardiopulmonary exercise test (CPET) measures, daily activity and major adverse cardiac events (MACE) at 3 and 12 months between pacing and sham groups. A "dose-response" analysis of outcomes at 2, 4, and 6 weeks of the intervention vs. sham compared with baseline will be performed.
Conditions Studied
Interventions
- DEVICE Exercise-similar cardiac pacing
- DEVICE Sham cardiac pacing
Study Locations (1)
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2024-06-26 |
| Est. Completion | 2028-11-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06332391
The ClinicalTrials.gov registry entry for NCT06332391 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 332-participant average among 13 other Heart Failure, Systolic trials with a reported enrollment target (84% lower). The listed sponsor is Denice Hodgson-Zingman, MD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Heart Failure, Systolic appearing as the primary indexed condition, and to 2 interventions - of which Exercise-similar cardiac pacing is the first listed.
NCT06332391 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT06332391 about?
NCT06332391 is a clinical study titled "Paced Heart Rate Acceleration for Cardiac Conditioning". A clinical trial of exercise-similar heart rate acceleration delivered via cardiac pacing vs. sham intervention in subjects at rest will be performed. The study population comprises subjects with guideline-directed medically managed left ventricular dysfunction due to ischemic or non-ischemic cardio...
What is the current status of trial NCT06332391?
This trial is currently recruiting. It is a NA study. The enrollment target is 52 participants. The study started on 2024-06-26. Estimated completion is 2028-11-30.
What conditions does trial NCT06332391 study?
This clinical trial studies the following conditions: Heart Failure, Systolic.
What interventions are being tested in trial NCT06332391?
The interventions under investigation include: Exercise-similar cardiac pacing (DEVICE), Sham cardiac pacing (DEVICE).
Who is sponsoring clinical trial NCT06332391?
This trial is sponsored by Denice Hodgson-Zingman, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06332391 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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