N/A
N=32
Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure
Heart Failure With a Preserved Ejection Fraction · Heart Failure, Diastolic · Chronotropic Incompetence
Bottom Line
View on ClinicalTrials.gov: NCT02145351 ↗Enrolled (actual)
32
Serious AEs
0.8%
Results posted
Apr 2023
Primary outcome: Primary: Change in Oxygen Consumption (VO2) at Ventilatory Anaerobic Threshold (VAT) — 10.4; 10.7 ml/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rate adaptive atrial pacing using a dual-chamber pacemaker (Device); Pacemaker system will be implanted but set to Pacing Off. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Oxygen Consumption (VO2) at Ventilatory Anaerobic Threshold (VAT) |
10.4; 10.7 | — |
| SECONDARY Peak Aerobic Capacity (Peak VO2) |
16.5; 16.8 | — |
| SECONDARY Ventilatory Efficiency (VE/VCO2) |
34.2; 34.9 | — |
| SECONDARY Change in Plasma N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) |
-88.0; -36.0 | — |
| SECONDARY Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score |
4.7; 3.8 | — |
Summary
Determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (HFpEF) and chronotropic incompetence (CI).
Eligibility Criteria
Inclusion Criteria
- Age >18 years and able to provide informed consent to enroll in the trial, or consent through a legal guardian or power of attorney.
- Previous clinical diagnosis of HF with current NYHA Class II-III symptoms
- At least one of the following: Hospitalization for decompensated HF, Acute treatment for HF with intravenous loop diuretic or hemofiltration, Chronic treatment with a loop diuretic for control of HF symptoms + left atrial enlargement on echocardiography or E/e' ratio (≥14 average, ≥15 septal ) on echocardiography, Resting PCWP >15 mm Hg or LV end-diastolic pressure >18 mmHg at catheterization for dyspnea and/or exercise PCWP/LV end-diastolic pressure >25 mmHg, or Elevated NT-proBNP level (≥300 pg/ml )
- Left ventricular EF ≥40% within 12 months with clinical stability
- Stable cardiac medical therapy for ≥30 days
- Sinus rhythm
- Chronotropic incompetence on recent (within 6 months) clinical or screening exercise test, defined as heart rate reserve (HRR) mild stenosis, >moderate regurgitation)
- Hypertrophic cardiomyopathy
- Infiltrative or inflammatory myocardial disease (amyloid, sarcoid)
- Pericardial disease
- Non-group 2 pulmonary arterial hypertension
- Chronic stable exertional angina
- Acute coronary syndrome or revascularization within 60 days
- Other clinically important causes of dyspnea
- Atrial fibrillation
- PR interval >210 msec
- Resting heart rate (HR) > 100 bpm
- A history of reduced ejection fraction (EF<40%)
- Advanced chronic kidney disease (GFR < 20 ml/min/1.73m2 by modified MDRD equation)
- Women of child bearing potential without negative pregnancy test and effective contraception
- Severe anemia (Hemoglobin <10 g/dL)
- Severe hepatic disease
- Complex congenital heart disease
- Listed for cardiac transplantation
- Other class I indications for pacing
Data sourced from ClinicalTrials.gov (NCT02145351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.