Red Blood Cell ATP Release and Vascular Function in Humans

NCT03404843 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 16-6361H
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (4)

• Forearm Blood Flow Responses to Hypoxia After Administration of Intervention

  Forearm blood flow measured using Doppler ultrasound before and after 5 minutes of exposure to hypoxia (breathing a mix of low-oxygen gas and room air to achieve oxygen saturations of \~80%).

  Within 4 hours after administration of intervention

• Forearm Blood Flow Responses to Exercise After Administration of Intervention

  Forearm blood flow measured using Doppler ultrasound before and during continuous rhythmic handgrip exercise at a low, moderate, and high intensity workload (4 minutes at each workload for 12 minutes in total).

  Within 4 hours after administration of intervention

• Change in ATP Release to Hypoxia After Administration of Intervention

  Venous plasma concentrations of ATP measured using a luminometer before and after 5 minutes of exposure to hypoxia (breathing a mix of low-oxygen gas and room air to achieve oxygen saturations of \~80%).

  Within 4 hours after administration of intervention

• Change in ATP Release to Exercise After Administration of Intervention

  Venous plasma concentrations of ATP measured using a luminometer before and during continuous rhythmic handgrip exercise at a low, moderate, and high intensity workload (4 minutes at each workload for 12 minutes in total).

  Within 4 hours after administration of intervention

Secondary Outcomes (1)

• Arterial Stiffness After Administration of Intervention

  Immediately following administration of intervention

Study Arms (2)

Fasudil hydrochloride

EXPERIMENTAL

Participants will receive a 100 mL intravenous infusion (in 60 minutes) of 60 mg of fasudil hydrochloride + saline prior to measurements of vascular function and ATP release.

Drug: Fasudil Hydrochloride

Saline

PLACEBO COMPARATOR

Participants will receive a 100 mL intravenous infusion (in 60 minutes) of saline (placebo) prior to measurements of vascular function and ATP release.

Other: Saline

Interventions

Fasudil Hydrochloride DRUG

10 mg/mL vial of fasudil hydrochloride. 6 mL (60 mg) of fasudil hydrochloride are added to a 100 mL saline bag for delivery to subjects.

Fasudil hydrochloride

Saline OTHER

100 mL saline bag.

Also known as: Placebo

Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy
• Sedentary to moderately active
• to 30 years old for young subjects
• to 80 years old for older subjects

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado State University: lead

Study Sites (1)

Colorado State University, Dept. of Health and Exercise Science

Fort Collins, Colorado, 80523, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

fasudil; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Frank Dinenno
• Organization: Colorado State University

frank.dinenno@colostate.edu

970-491-3203

Study Officials

• Frank Dinenno, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A person not associated with any data collection or data analysis is randomizing the treatment and preparing it in a separate room. All data is collected as visit 1 or visit 2.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a randomized, double-blind, placebo-controlled, crossover study. Approximately 20 young and 20 older adults will be recruited for participation and randomly assigned to either a placebo (saline) infusion or a fasudil hydrochloride infusion. The dose of fasudil hydrochloride is 60 mg/ 60 min.

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: January 19, 2018
• Study Start: July 14, 2017
• Primary Completion: October 5, 2018
• Study Completion: October 5, 2018
• Last Updated: February 27, 2020
• Results First Posted: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)