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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT01997866
Eligibility Criteria:
Inclusion criteria:
* Patient has:
1. CHF (systolic, diastolic, any etiology), or
2. Normal Ejection Fraction (EF) and most recent:
1. Age less than 50: N-Terminal Pro Brain Natriuretic Peptide (NTPBNP) \> 400,
2. Age 50 and older: NTPBNP \> 750,
3. If no NTPBNP done: then Brain Natriuretic Peptide (BNP) \> 200 (some newly referred patients will only have this available at their first visit, or
3. Normal EF, no BNP done, and CHF documented in History or Problem List
* Admitted to the Hospital Medicine service, General Medicine Teaching service, Medicine Cardiology Team (MCT) service, Heart Failure service, or Community Health and Family Medicine (CHFM) service, OR Patient of the Congestive Heart Failure Clinic
* Patient has had at least 2 encounters (hospital inpatient admission, hospital observation admission, or ED visit) with University of Florida (UF) Health during the 12-month period immediately prior to the current admission (not including the current admission).
* English Speaking
* Males \& Females
* Age 18 to 110
* Agreement to return to Gainesville for regular follow-up visits
Exclusion criteria:
* Decisionally impaired, cognitively impaired, or demented patient who has a surrogate, proxy, or guardian
* Current Drug/Alcohol abuse as evidenced by a) positive urine toxicology screen for cocaine or amphetamines during current admission, b) positive blood alcohol level upon admission, or c) documentation by current providers of continued abuse of alcohol or drugs
* Previous diagnosis of sleep apnea and on current treatment
* Uncontrolled Ventricular Dysrhythmias; sustained episodes of ventricular tachycardia or ventricular fibrillation in the hospital
* Evidence of current ischemia evidenced by elevated Troponin unrelated to Chronic Kidney Disease, or \< 6 weeks since Myocardial Infarction (MI)
* Palliative care or Life expectancy \< 6 months
* Isolated Cor Pulmonale - predominantly right ventricular dysfunction, Right Ventricular Systolic Pressure (RVSP) \>50 and/or on the following medications for pulmonary hypertension: sildenafil (Viagra®), tadalafil (Adcirca®, Cialis®), IV or sub-cutaneous (SC) treprostinil (Remodulin®; Tyvaso™), ambrisentan (Letairis®), bosentan (Tracleer®), IV epoprostenol, inhaled iloprost (Ventavis®)
* On 5 liters or greater of O2
* Self-Pay Status
* Known Pregnancy
* Vulnerable Subjects such as prisoners, decisionally impaired/comatose individuals, terminally ill patients, UF/Shands/Veterans Administration (VA) staff, UF students
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
110 Years
Study:
NCT01997866
Study Brief:
Protocol Section:
NCT01997866