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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT02164318
Eligibility Criteria:
Inclusion Criteria:
1. Life expectancy of at least 6 months
2. Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
3. Ability to understand and comply with the requirements of the entire study and communicate with the study team.
4. Written informed consent using a document that has been approved by the Duke Human Institutional Review Board.
5. If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative pregnancy test and be willing to use contraception until completion of 8 weeks of intervention. This will include abstinence, barrier methods, hormones, or intra-uterine device.
Exclusion Criteria:
1. Patients currently on medication that is contraindicated with nitropaste, including isosorbide nitrate therapy, nitroglycerin, minoxidil, or PDE inhibitors (i.e. Sildenafil).
2. Patients with a diastolic blood pressure below 65 or a systolic blood pressure below 90.
3. Patients with a history of illicit drug use in the previous 5 years.
4. Patients who would require AVF placement before completion of the initial 4 weeks of intervention therapy
5. Patients who are otherwise are not suitable for 8 weeks of handgrip training or nitropaste therapy.
6. Patients under the 18 of age are not eligible for nitropaste interventions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT02164318
Study Brief:
Protocol Section:
NCT02164318