Clinical trial NCT05600725: Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure
Official title: Novel Pacing Modality to Initiate Favorable Cardiac Remodeling in Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiomyopathies
Heart Rate
Conditioning
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized in a single-blinded fashion to intervention vs. sham treatment
Primary purpose: TREATMENT

Brief summary: This project utilizes a novel cardiac pacing approach hypothesized to initiate beneficial cardiac conditioning and remodeling over a period of time.

Detailed description: The project studies subjects with non-ischemic cardiomyopathy who have a pacing device already implanted. Subjects randomized to the pacing intervention versus a sham intervention will be compared for various symptomatic, functional and other outcomes. Each subject will undergo baseline quality of life/symptom questionnaires and clinical testing for cardiac functional/structural effects and exercise tolerance, then the intervention vs. sham (subjects blinded to their category), followed by repeat questionnaires and clinical testing. Medical record review will be undertaken to establish demographic variables, baseline and follow up testing results.

Eligibility criteria: Inclusion Criteria:

* Non-Ischemic Cardiomyopathy
* Ejection Fraction \</= 35% despite at least 3 months stable standard medical management
* New York Heart Association Class II-III symptoms
* Dual chamber implantable cardioverter defibrillator in place or Biventricular ICD in place (over 3 months old)
* Normal Atrioventricular conduction or Biventricular ICD
* QRS \< 120 msec (inherent conduction or paced with BiV ICD)

Exclusion criteria:

* Age \< 18 years
* Inability to ambulate safely
* Congenital or primary valve disease
* Left Ventricular thrombus
* Severe peripheral arterial disease
* Admission for life-threatening condition (eg heart failure, stroke) in the past 3 months
* Major surgery in the past 3 months or anticipated during the period of the trial
* Paced or intrinsic QRS \>120 msec
* Life expectancy \< 1 year
* Hemodialysis
* Hematocrit \< 30%
* Severe Chronic lung disease
* Pregnancy
* ICD battery longevity \< 1 year
* Unsuppressed atrial arrhythmias
* Already participating in an exercise programusion Criteria

Primary outcomes:
measure: Quality of life/symptom score
timeFrame: 4 weeks after start of the protocol
Secondary outcomes:
measure: systolic blood pressure
timeFrame: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
measure: diastolic blood pressure
timeFrame: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
measure: Oxygen saturation
timeFrame: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
measure: cardiac output
timeFrame: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
measure: MACE
timeFrame: 4 weeks and 4 months after start of the protocol
measure: six minute walk
timeFrame: at the time of enrollment, and at 4 weeks after start of the protocol
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Denice Hodgson-Zingman, MD
role: PRINCIPAL_INVESTIGATOR
References: