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:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT01542502
Eligibility Criteria:
Inclusion Criteria:
* Symptoms and signs of congestive heart failure
* Recent Imaging Study (\<12 months) showing Left Ventricular Ejection Fraction (LVEF) \>50% and Left Ventricular End Diastolic Volume Index (LVEDVI) \<97ml/m2
* Evidence of abnormal Left Ventricular (LV) relaxation, filling, diastolic distensibility, and diastolic stiffness as shown by one of the following:
1. Invasive Hemodynamic measurements
* mean Pulmonary Capillary Wedge pressure (mPCW) \>12
* Left Ventricular End Diastolic Pressure (LVEDP) \>16 mmHg
2. Tissue Doppler Echocardiogram
* E/E' \>15
* E/E' 8-15 and one of the following
* Left Ventricular Hypertrophy (LVH)
* Atrial Fibrillation
* Left Atrial Enlargement
* E/A \<0.5 + Deceleration Time (DT) \>280 (if \>50yrs of age)
3. Biomarkers
* Brain Natriuretic Peptide (BNP) \>200pg/mL
Exclusion Criteria:
* Age \<18
* Recent changes (previous 3 months) in HF maintenance medications (beta-blockers, angiotensin converting enzyme \[ACE\] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics)
* Hospitalization for worsening Heart Failure (HF) or acute decompensated HF within the previous 12months
* Anticipated need for cardiac resynchronization therapy (CRT) or automated-implantable cardioverter defibrillator (AICD)
* Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing
* Active infection including chronic infection
* Active cancer
* Recent (\<14 days) use of anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs \[NSAIDs\]), Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to complete the study
* Pregnancy (determined by urine pregnancy test in women of childbearing potential)
* Inability to give informed consent
* Other conditions limiting completion of cardiopulmonary exercise test or completion of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01542502
Study Brief:
Protocol Section:
NCT01542502