Exercise-induced Erythropoiesis: the Mechanistic of Angiotensin II

NCT05269615 | Unknown Phase 4

• 1 other identifier: 19200831
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The major aims are to determine the effect of acute (single dose) blockade of ANGII receptor 1 (AT1) on the EPO response to a single session of endurance exercise, as well as determine the effect of chronic (8-week) blockade of AT1 on ET-induced adaptations in total circulating red blood volume and hemoglobin.

Conditions

Exercise Physiology

Outcome Measures

Primary Outcomes (3)

• stroke volume in ml/m2

  Stroke volume (SV) will be determined as left ventricular end-diastolic volume (LVEDV) minus left ventricular end-systolic volume (LVESV)

  10 weeks

• maximal oxygen consumption in ml/kg/min

  Maximal oxygen consumption (VO2max), a hallmark of aerobic capacity, will be determined with continuous measurements of oxgyen uptake using an online gas collection system (Quark CPET, Cosmed, Italy)

  10 weeks

• Blood volume (BV)-regulating hormone: Plasma ANGII in ng/dL

  Plasma ANGII concentrations will be quantified by means of established competitive enzyme immunoassays

  10 weeks

Study Arms (2)

Valsartan tablets

ACTIVE COMPARATOR

Drug: Valsartan 80 mg

Placebo tablets

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Valsartan 80 mg DRUG

The well-established angiotensin II receptor blocker (ARB) valsartan will be used in the present study to selectively block AT1 receptors. Valsartan is a generic medication widely used in hypertensive patients since 1996 as well as safely applied in physiological studies comprising healthy individuals.1-3 A minimal valsartan dose of 80 mg known to acutely reduce circulating EPO levels in healthy individuals will be provided 4 hours before starting Study 1 to optimize AT1 blockade according to valsartan's half-life.1-3 The same dose of valsartan (80 mg) will be provided 4 hours before each ET session in Study 2. The participants will be randomly allocated in a 1:1 ratio to valsartan or placebo. Valsartan and placebo tablets will be indistinguishable in taste, smell, appearance and dosage. The protocol will be developed in a double-blind manner in that both participants and investigators will be blinded toward the intervention condition.

Valsartan tablets

Placebo DRUG

The participants will be randomly allocated in a 1:1 ratio to valsartan or placebo. Valsartan and placebo tablets will be indistinguishable in taste and smell. The protocol will be developed in a double-blind manner in that both participants and investigators will be blinded toward the intervention condition.

Placebo tablets

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy status, absence of current medical symptoms or medication limiting incremental exercise testing
• No history of cardiac, pulmonary or kidney disease.

You may not qualify if:

• \- Individuals fulfilling the above criteria but currently involved in regular exercise training (\> 5 hr/week)

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

School of Public Health

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

Valsartan

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Central Study Contacts

David Montero Barril, PhD

CONTACT

66924724; dvmb@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be randomly allocated in a 1:1 ratio to valsartan or placebo. Valsartan and placebo tablets will be indistinguishable in taste, smell, appearance and dosage. The protocol will be developed in a double-blind manner in that both participants and investigators will be blinded toward the intervention condition.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 8, 2022
• Study Start: March 20, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 9, 2024

Record last verified: 2023-12

Locations

HK (1)