Exercise PhysiologyPhase 4NCT05269615
Exercise-induced Erythropoiesis: the Mechanistic of Angiotensin II
A Phase 4 study testing Valsartan 80 mg in people with Exercise Physiology, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exercise Physiology
- What is being tested?
- Valsartan 80 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Mar 2023to 30 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy status, absence of current medical symptoms or medication limiting incremental exercise testing
- No history of cardiac, pulmonary or kidney disease.
Who cannot join
- Individuals fulfilling the above criteria but currently involved in regular exercise training (> 5 hr/week)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Public Health
Hong Kong
David Montero, PhD, 28315250, dvmb@hku.hk
About this study
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.
Read the detailed description
Physical activity, particularly when comprised of endurance training (ET) leading to cardiovascular adaptations, is considered the most effective intervention to augment life expectancy. Major health benefits induced by ET are closely associated (independently of traditional risk factors) with improvements in maximal oxygen consumption (VO2max), a hallmark of aerobic exercise capacity. The higher the VO2max the greater the likelihood to be free of cardiovascular disease, the main cause of mortality worldwide. Understanding the mechanisms explaining the improvement in VO2max with ET can provide sound basis for highly effective lifestyle and pharmacological interventions aimed to enhance cardiovascular health in the general population. So far, the essential role of ET-induced increased formation of red blood cells, i.e., erythropoiesis, has been firmly established for any improvement in VO2max. Yet, the underlying mechanism remains elusive. Clinical studies and recent investigations by the PI point towards the endocrine effects of key hormones that regulate blood volume (BV). Notably, the impact of ET-induced changes in angiotensin II (ANGII), a multifaceted hormone that modulates erythropoiesis through its effects on kidney erythropoietin (EPO) production, has to be experimentally elucidated in humans.
- Conditions
- Exercise Physiology
- Being tested
- Valsartan 80 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan 80 mgDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Valsartan tablets | Active comparator | Not described Receives: Drug: Valsartan 80 mg |
| Placebo tablets | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start20 Mar 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise PhysiologyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269615
- Sponsor's protocol ID
- 19200831
- Status last verified
- Dec 2023
- First submitted
- 4 Feb 2022
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-induced Erythropoiesis: the Mechanistic of Angiotensin II
- ClinicalTrials.gov ID
- NCT05269615
- Acronym / sponsor ID
- 19200831
- Conditions
- Exercise Physiology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Physical activity, particularly when comprised of endurance training (ET) leading to cardiovascular adaptations, is considered the most effective intervention to augment life expectancy. Major health benefits induced by ET are closely associated (independently of traditional risk factors) with improvements in maximal oxygen consumption (VO2max), a hallmark of aerobic exercise capacity. The higher the VO2max the greater the likelihood to be free of cardiovascular disease, the main cause of mortality worldwide. Understanding the mechanisms explaining the improvement in VO2max with ET can provide sound basis for highly effective lifestyle and pharmacological interventions aimed to enhance cardiovascular health in the general population. So far, the essential role of ET-induced increased formation of red blood cells, i.e., erythropoiesis, has been firmly established for any improvement in VO2max. Yet, the underlying mechanism remains elusive. Clinical studies and recent investigations by the PI point towards the endocrine effects of key hormones that regulate blood volume (BV). Notably, the impact of ET-induced changes in angiotensin II (ANGII), a multifaceted hormone that modulates erythropoiesis through its effects on kidney erythropoietin (EPO) production, has to be experimentally elucidated in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valsartan tablets | Active comparator | Drug: Valsartan 80 mg |
| Placebo tablets | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy status, absence of current medical symptoms or medication limiting incremental exercise testing
- No history of cardiac, pulmonary or kidney disease.
Key exclusion criteria (1 listed)
- Individuals fulfilling the above criteria but currently involved in regular exercise training (> 5 hr/week)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valsartan 80 mgThe 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. | Drug | Valsartan tablets |
| PlaceboThe 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. | Drug | Placebo tablets |
Primary outcome
stroke volume in ml/m2
Time frame: 10 weeks
Stroke volume (SV) will be determined as left ventricular end-diastolic volume (LVEDV) minus left ventricular end-systolic volume (LVESV)
maximal oxygen consumption in ml/kg/min
Time frame: 10 weeks
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)
Blood volume (BV)-regulating hormone: Plasma ANGII in ng/dL
Time frame: 10 weeks
Plasma ANGII concentrations will be quantified by means of established competitive enzyme immunoassays
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valsartan 80 mg in people with Exercise Physiology, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Montero Barril, PhD (66924724, dvmb@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke volume in ml/m2 (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.