Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT02145351
Eligibility Criteria:
Inclusion Criteria
1. Age \>18 years and able to provide informed consent to enroll in the trial, or consent through a legal guardian or power of attorney.
2. Previous clinical diagnosis of HF with current NYHA Class II-III symptoms
3. 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 )
4. Left ventricular EF ≥40% within 12 months with clinical stability
5. Stable cardiac medical therapy for ≥30 days
6. Sinus rhythm
7. Chronotropic incompetence on recent (within 6 months) clinical or screening exercise test, defined as heart rate reserve (HRR) \<0.80 or \<0.62 if on beta blockers
8. Meet both screening criteria on clinically-performed cardiopulmonary exercise testing within 12 months.
Exclusion Criteria
1. Inability to exercise, or non-cardiac condition that precludes exercise testing
2. Any contraindication to a pacemaker system
3. Non-cardiac condition limiting life expectancy to less than one year
4. Significant left sided structural valve disease (\>mild stenosis, \>moderate regurgitation)
5. Hypertrophic cardiomyopathy
6. Infiltrative or inflammatory myocardial disease (amyloid, sarcoid)
7. Pericardial disease
8. Non-group 2 pulmonary arterial hypertension
9. Chronic stable exertional angina
10. Acute coronary syndrome or revascularization within 60 days
11. Other clinically important causes of dyspnea
12. Atrial fibrillation
13. PR interval \>210 msec
14. Resting heart rate (HR) \> 100 bpm
15. A history of reduced ejection fraction (EF\<40%)
16. Advanced chronic kidney disease (GFR \< 20 ml/min/1.73m2 by modified MDRD equation)
17. Women of child bearing potential without negative pregnancy test and effective contraception
18. Severe anemia (Hemoglobin \<10 g/dL)
19. Severe hepatic disease
20. Complex congenital heart disease
21. Listed for cardiac transplantation
22. Other class I indications for pacing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02145351
Study Brief:
Protocol Section:
NCT02145351