Paced heart rate acceleration for improving heart function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of exercise-similar heart rate acceleration delivered through cardiac pacing compared to a sham intervention in patients with systolic heart failure. The study involves 52 participants who will be randomly assigned to receive either the pacing intervention or a sham treatment three times a week for six weeks. The trial aims to assess changes in symptoms, functional capacity, and heart structure by measuring various clinical outcomes before, during, and after the intervention period. The research is conducted at the University of Iowa, with statistical analysis performed by the Cleveland Clinic.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female sex
* Age 18 years or greater
* Available transportation for study visits
* Left ventricular ejection fraction \< or = 40% despite at least 3 months guideline-directed medial therapy
* NYHA class II-III heart failure symptoms
* Atrial-lead inclusive implantable cardioverter defibrillator or biventricular defibrillator in place \> 3 months
* Intrinsic or biventricular paced QRS duration of \<= 120 milliseconds

Exclusion Criteria:

* Age \< 18 years
* Inability to ambulate safely
* Congenital or primary valve disease
* Ongoing (not suppressed) atrial arrhythmias
* Left ventricular thrombus
* Severe peripheral arterial disease that limits mobility
* Hospital admission for life-threatening condition (e.g. heart failure, stroke) in the past 3 months
* Major surgery in the past 3 months or anticipated during the period of study
* Ventricular pacing indication in the absence of biventricular pacing
* Life expectancy \< 1 year
* Hemodialysis
* Hematocrit \< 30%
* Severe chronic lung disease that limits activity or requires oxygen
* Pregnancy
* Implantable cardioverter defibrillator battery longevity \< 1 year
* Vulnerable populations such as prisoners and institutionalized individuals

Where it's running

• University of Iowa Hospitals and Clinics
  Iowa City, Iowa, United States Recruiting

Study contacts

• Principal investigator: Denice Hodgson-Zingman, MD — University of Iowa
• Study coordinator: Denice Hodgson-Zingman, MD
• Email: denice-zingman@uiowa.edu
• Phone: +1 319 384 2915

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.