Phase 2
N=31
Red Blood Cell ATP Release and Vascular Function in Humans
Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03404843 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Forearm Blood Flow Responses to Hypoxia After Administration of Intervention — 6.3; 6.2; 2.1; 8.4 mL/min — p=0.97
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fasudil Hydrochloride (Drug); Saline (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colorado State University
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forearm Blood Flow Responses to Hypoxia After Administration of Intervention |
6.3; 6.2; 2.1; 8.4 | 0.97 |
| PRIMARY Forearm Blood Flow Responses to Exercise After Administration of Intervention |
315.4; 283.0; 255.3; 304.2 | <0.05 sig |
| PRIMARY Change in ATP Release to Hypoxia After Administration of Intervention |
21.6; 5.3; 5.3; 17.4 | 0.28 |
| PRIMARY Change in ATP Release to Exercise After Administration of Intervention |
45.6; 42.2; 28.4; 46.2 | 0.89 |
| SECONDARY Arterial Stiffness After Administration of Intervention |
5.4; 5.2; 7.8; 7.6 | 0.08 |
Summary
Previous work demonstrates that the red blood cells of older adults do not release a potent vasodilator (ATP) as well as the red blood cells of younger adults. The investigators are targeting a pathway within the red blood cell using fasudil hydrochloride to determine if both the release of ATP from red blood cells and blood flow responses to low oxygen (hypoxia) and exercise in older adults can be improved.
Eligibility Criteria
Inclusion Criteria
- Healthy
- Sedentary to moderately active
- 18 to 30 years old for young subjects
- 60 to 80 years old for older subjects
Exclusion Criteria
- Obesity (BMI ≥ 30 kg/m^2)
- Cardiovascular disease
- Metabolic disease
- Use of medications that can influence cardiovascular function
- Blood pressure greater than or equal to 140/90
- Smoker
- Use of hormone replacement therapy
Data sourced from ClinicalTrials.gov (NCT03404843). 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.