Heart FailurePhase 2ONOHNCT02918552
Oral Nitrite for Older Heart Failure With Preserved Ejection Fraction
A Phase 2 study testing sodium nitrite in people with Heart Failure, run by Gladwin, Mark, MD at 1 site in United States.
Trial summary
This is a randomized double blinded controlled trial of 20-40 mg sodium nitrite tid in subjects with HFpEF. Primary outcomes are measures of physical function with non-invasive and invasive cardiopulmonary exercise testing, and fatigability, skeletal muscle bioenergetics, serology including inflammatory markers and… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- sodium nitrite
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2017to 31 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥70 years
- Diagnosis of HFpEF [adapted from the 2016 European Society of Cardiology (ESC) Guidelines to include:
- 1. Prior diagnosis of HF via one of these:
- medical record diagnosis by attending cardiologist
- verbal confirmation of HFpEF with attending cardiologist
- PI review of medical record to confirm HFpEF AND 2. Ejection Fraction % ≥40
Show all 9Show fewer
- Clinically stable (euvolemic; baseline heart rate <100 bpm) and without hospitalization or invasive cardiac procedure for 6 weeks
- Patients using 81 milligram (mg) aspirin (ASA) will be eligible, but will be asked to hold the medication for 3 days prior to biopsy. This technique has previously been used with consistent safety. Patients will also be asked to avoid non-steroidal anti-inflammatory medications (NSAIDs) for 2 days prior to the biopsy.
- Patients using anti-thrombin and anti-platelet therapy will plan to modify prior to muscle biopsies individually in coordination with the participant's primary cardiologist.
Who cannot join
- Allergy to lidocaine
- BP >180/95 or <100/60
- Anemia: Hgb<11.0 (♂),10.0 (♀)
- Dementia or inability to give informed consent
- End-stage malignancy
- Severe orthopedic exercise limitation
Show all 20Show fewer
- Use of chronic oral corticosteroids or other medications that affect muscle function.
- Chronic alcohol or drug dependency.
- Any bleeding disorder that would contraindicate biopsy such as history of clinically significant bleeding diathesis (e.g., Hemophilia A or B, Von Willebrand's Disease or congenital Factor VII deficiency).
- Psychiatric hospitalization within the last 3 months
- Major cardiovascular event or procedure within the prior 6 weeks
- HF secondary to significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction). If valve replacement has been performed, patient may not be enrolled for 12 months after this procedure.
- Severe uncorrected primary valvular heart disease (if valve replacement has been performed, patients will not be eligible for at least 12 months)
- Mechanical valve replacement requiring warfarin
- Peripheral or pulmonary artery disease
- Currently taking clopidogrel for a recent stent placement and/or a complex atherosclerotic lesion such that holding clopidogrel creates disproportionate risk.
- Current use of organic nitrates or phosphodiesterase type 5 inhibitors (PDE5s)
- Unable to hold warfarin or use bridging therapy, or to hold aspirin for 3 days (81 mg), 3 days (325 mg) prior to muscle biopsy or thienopyridine medications for 5 days prior to muscle biopsy.
- Subjects with diabetes whose HgbA1c >10.0
- Other chronic unstable disease such as active neoplasm, end stage chronic kidney, liver or other organ disease,
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Nitrite Benefits to Mediate Fatigability in Older HFpEF Patients
This is a randomized double blinded controlled trial of 20-40 mg sodium nitrite tid in subjects with HFpEF. Primary outcomes are measures of physical function with non-invasive and invasive cardiopulmonary exercise testing, and fatigability, skeletal muscle bioenergetics, serology including inflammatory markers and platelet bioenergetics, quality of life measures.
Read the detailed description
Age-related physiological changes predispose to heart failure with preserved ejection fraction (HFpEF). Thus, HFpEF prevalence is escalating as the older population expands. High mortality and morbidity, diminished quality of life, and spiraling healthcare costs are typical consequences, and no effective HFpEF therapy is known. Therefore, several small exercise training (ExT) trials for HFpEF stand out by showing that ExT result in improved aerobic exercise capacity and infer that ExT constitutes novel substantive therapy. Nonetheless, such benefit was evident only after months of moderate to high intensity ExT; regimens that are unfeasible for most patients. In fact, poor compliance with ExT is typical in most HFpEF patients. The investigators propose there are intrinsic physiological components of HFpEF pathophysiology that predispose to "fatigability". The investigators advance the concept of fatigability by quantifying it as a performance-based measure; i.e., subjective tiring during a standardized steady-state walking (perceived fatigability) and deterioration of self-selected walking speed over time (performance fatigability). The investigators assert that therapies to reduce fatigability will enhance HFpEF outcomes. Ongoing studies reveal pleiotropic benefits of oral inorganic nitrite (NO2), including enhanced performance of skeletal muscle (metabolism and bioenergetics) and vasomotor responses (systemic and pulmonary). The investigators' pilot work shows safety and biological efficacy of oral NO2 capsules. Thus, the investigators propose a randomized, controlled, double-blinded trial to study oral NO2 therapy in older (≥70 years) HFpEF patients. Aim 1 explores the utility of NO2 capsules to reduce perceived and performance fatigability (rated perceived exertion), improve aerobic capacity (peak oxygen uptake) and increase daily activity (accelerometry). Aim 2 delineates the mediating processes by which NO2 benefits are achieved. Skeletal muscle determinants are differentiated from the right and left heart vasomotor dynamics by integrating assessments using 31Phosphorus magnetic resonance spectroscopy and percutaneous needle muscle biopsies with those made using non-invasive and invasive cardiopulmonary exercise testing, near infrared spectroscopy and other techniques. The principal investigator is trained geriatrics and cardiology, and is solidly oriented to the dynamics of aging and cardiovascular disease (clinically and mechanistically) with particular expertise in functional assessment and skeletal muscle gene expression as determinants of performance. The investigative team provides formidable synergies that are well-suited to this translational investigation of systemic, cellular, and sub-cellular physiological dynamics. Our proposal is significant in multiple respects: 1) HFpEF is endemic with aging and constitutes a critical contemporary healthcare challenge today's growing population of older adults. 2) Fatigability is rooted in HFpEF pathophysiology, but it has not previously been addressed as a key part of management. 3) NO2 therapy is a novel and compelling therapeutic strategy. 4) Mechanisms underlying fatigability are clarified; we advance principles of patient-centered care by clarifying mechanisms that underlie a patient's experience of fatigability.
- Conditions
- Heart Failure
- Being tested
- sodium nitrite, Control
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium nitriteDrug
Also called nitrite
Subjects to receive active study drug three times daily during treatment period and then post treatment testing period.
ControlDrug
Also called Placebo
Subjects randomized to placebo to receive three times daily during treatment period and then post treatment testing period.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 20 or 40 mg sodium nitrite tid Receives: Drug: sodium nitrite |
| Control | Placebo comparator | 20 or 40 mg placebo tid Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory Fitness
Assessment of peak Oxygen uptake (VO2) maximum via symptom limited exercise testing
Measured: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
Secondary outcomes (14)
Perceived Fatigability
Assessment of Rate of Perceived Exertion (RPE) during steady state exercise testing at the last minute of the test. The RPE scale (Rate of Perceived Exertion) goes from 6-20 with a higher number indicating more effort and possibly a worse outcome.
Measured: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
Bioenergetics: In-Vivo 31P MRS Respirations
Phosphocreatine reuptake after exercise during the kicking exercise in the 31P MRS (magnetic resonance spectroscopy)
Measured: Week 3 (pre drug) to week 10(post drug); approx. 8 weeks
Bioenergetics: Ex-Vivo Mitochondrial Respiration Analysis
Mitochondrial respiration was analyzed by assessing O2 consumption by skeletal muscle mitochondria at Energetic State 3.1 using the Oroboros instrument. This state is generally used a marker for mitochondrial efficiency. Increases in consumption are generally linked to a better outcome.
Measured: Week 5 (pre-drug) to week 16 (post-drug); approx. 8 weeks
Exercise-induced Changes in Pulmonary Arterial Pressure
Pulmonary arterial pressure, an indication of cardiopulmonary hemodynamics and cardiac function, was measured at rest and at peak exercise during an invasive cardiopulmonary exercise test.
Measured: Week 3 (pre-drug) to week 10 (post drug); approx 8 weeks
Exercise-induced Changes in Pulmonary Capillary Wedge Pressure
Pulmonary capillary wedge pressure, an indication of cardiopulmonary hemodynamics and cardiac function, was measured at rest and at peak exercise during an invasive cardiopulmonary exercise test.
Measured: Week 3 (pre-drug) to week 10 (post drug); approx 8 weeks
Patients With Pulmonary Hypertension
Right Ventricular-Pulmonary Artery Coupling, assessed by right ventricular ejection fraction (RVEF) and pulmonary artery systolic pressure (PASP), decreases with worsening right heart failure. We will be measuring this by assessing RVEF and PASP during invasive cardiopulmonary exercise testing in patients that meet criteria for pulmonary hypertension.
Measured: Week 3 (pre-drug) to week 10 (post drug); approx 8 weeks
Steps From Accelerometry Assessment of Daily Activity
Actigraph device-specific activity steps on daily-wear wrist device based on movement.
Measured: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Sedentary Events From Accelerometry Assessment of Daily Activity
Assessment of daily activity using accelerometry on a daily-wear wrist device.
Sedentary bout is a triggered stint of time that the patient is not moving or has low level of activity sensed by the accelerometer.
Measured: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Light Activity Duration From Accelerometry Assessment of Daily Activity
Assessment of daily activity using accelerometry on a daily-wear wrist device.
Light activity is a triggered stint of time that the patient has a slightly elevated amount of activity based on biometrics such as movement and heart rate.
Measured: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Moderate to Vigorous Physical Activity From Accelerometry Assessment of Daily Activity
Assessment of daily activity using accelerometry on a daily-wear wrist device.
MVPA is Moderate-to-vigorous physical activity that is a triggered stint of time that the patient has a slightly elevated amount of activity based on biometrics such as movement and heart rate.
Measured: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Vector Magnitude Counts From Accelerometry Assessment of Daily Activity
Assessment of daily activity using accelerometry on a daily-wear wrist device.
Vector Magnitude in counts per day are accelerations in 3 dimensions that indicate activity. More counts is associated with more activity. More counts in a shorter duration of time indicate light, moderate, and vigorous activity.
Measured: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Sedentary Event Duration From Accelerometry Assessment of Daily Activity
Assessment of daily activity using accelerometry on a daily-wear wrist device.
Sedentary bout is a triggered stint of time that the patient is not moving or has low level of activity sensed by the accelerometer.
Measured: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Light Activity Events Percentage of Day From Accelerometry Assessment of Daily Activity
Assessment of daily activity using accelerometry on a daily-wear wrist device.
Light activity is a triggered stint of time that the patient has a slightly elevated amount of activity based on biometrics such as movement and heart rate.
Measured: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Moderate to Vigorous Physical Activity Percentage From Accelerometry Assessment of Daily Activity
Assessment of daily activity using accelerometry on a daily-wear wrist device.
MVPA is Moderate-to-vigorous physical activity that is a triggered stint of time that the patient has a slightly elevated amount of activity based on biometrics such as movement and heart rate.
Measured: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start3 Apr 2017
- Primary completion2 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gladwin, Mark, MD
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Daniel Forman, MD, University of Pittsburgh
- Investigators
- Daniel E Forman, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918552
- Sponsor's protocol ID
- STUDY19070450
- Other IDs
- 1R56AG051637-01A1
- Acronym
- ONOH
- Status last verified
- Jan 2020
- First submitted
- 13 Sep 2016
- Last updated
- 22 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with other future investigators as research questions arise.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrite Benefits to Mediate Fatigability in Older HFpEF Patients
- ClinicalTrials.gov ID
- NCT02918552
- Acronym / sponsor ID
- ONOH / STUDY19070450
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Gladwin, Mark, MD
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 2 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized double blinded controlled trial of 20-40 mg sodium nitrite tid in subjects with HFpEF. Primary outcomes are measures of physical function with non-invasive and invasive cardiopulmonary exercise testing, and fatigability, skeletal muscle bioenergetics, serology including inflammatory markers and platelet bioenergetics, quality of life measures.
Detailed description
Age-related physiological changes predispose to heart failure with preserved ejection fraction (HFpEF). Thus, HFpEF prevalence is escalating as the older population expands. High mortality and morbidity, diminished quality of life, and spiraling healthcare costs are typical consequences, and no effective HFpEF therapy is known. Therefore, several small exercise training (ExT) trials for HFpEF stand out by showing that ExT result in improved aerobic exercise capacity and infer that ExT constitutes novel substantive therapy. Nonetheless, such benefit was evident only after months of moderate to high intensity ExT; regimens that are unfeasible for most patients. In fact, poor compliance with ExT is typical in most HFpEF patients. The investigators propose there are intrinsic physiological components of HFpEF pathophysiology that predispose to "fatigability". The investigators advance the concept of fatigability by quantifying it as a performance-based measure; i.e., subjective tiring during a standardized steady-state walking (perceived fatigability) and deterioration of self-selected walking speed over time (performance fatigability). The investigators assert that therapies to reduce fatigability will enhance HFpEF outcomes. Ongoing studies reveal pleiotropic benefits of oral inorganic nitrite (NO2), including enhanced performance of skeletal muscle (metabolism and bioenergetics) and vasomotor responses (systemic and pulmonary). The investigators' pilot work shows safety and biological efficacy of oral NO2 capsules. Thus, the investigators propose a randomized, controlled, double-blinded trial to study oral NO2 therapy in older (≥70 years) HFpEF patients. Aim 1 explores the utility of NO2 capsules to reduce perceived and performance fatigability (rated perceived exertion), improve aerobic capacity (peak oxygen uptake) and increase daily activity (accelerometry). Aim 2 delineates the mediating processes by which NO2 benefits are achieved. Skeletal muscle determinants are differentiated from the right and left heart vasomotor dynamics by integrating assessments using 31Phosphorus magnetic resonance spectroscopy and percutaneous needle muscle biopsies with those made using non-invasive and invasive cardiopulmonary exercise testing, near infrared spectroscopy and other techniques. The principal investigator is trained geriatrics and cardiology, and is solidly oriented to the dynamics of aging and cardiovascular disease (clinically and mechanistically) with particular expertise in functional assessment and skeletal muscle gene expression as determinants of performance. The investigative team provides formidable synergies that are well-suited to this translational investigation of systemic, cellular, and sub-cellular physiological dynamics. Our proposal is significant in multiple respects: 1) HFpEF is endemic with aging and constitutes a critical contemporary healthcare challenge today's growing population of older adults. 2) Fatigability is rooted in HFpEF pathophysiology, but it has not previously been addressed as a key part of management. 3) NO2 therapy is a novel and compelling therapeutic strategy. 4) Mechanisms underlying fatigability are clarified; we advance principles of patient-centered care by clarifying mechanisms that underlie a patient's experience of fatigability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: sodium nitrite20 or 40 mg sodium nitrite tid |
| Control | Placebo comparator | Drug: Control20 or 40 mg placebo tid |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Age ≥70 years
- Diagnosis of HFpEF [adapted from the 2016 European Society of Cardiology (ESC) Guidelines to include:
- medical record diagnosis by attending cardiologist
- verbal confirmation of HFpEF with attending cardiologist
- PI review of medical record to confirm HFpEF AND 2. Ejection Fraction % ≥40
Key exclusion criteria (20 listed)
- Allergy to lidocaine
- BP >180/95 or <100/60
- Anemia: Hgb<11.0 (♂),10.0 (♀)
- Dementia or inability to give informed consent
- End-stage malignancy
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 |
|---|---|---|
| sodium nitriteAlso: nitriteSubjects to receive active study drug three times daily during treatment period and then post treatment testing period. | Drug | Treatment |
| ControlAlso: PlaceboSubjects randomized to placebo to receive three times daily during treatment period and then post treatment testing period. | Drug | Control |
Primary outcome
Cardiorespiratory Fitness
Time frame: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
Assessment of peak Oxygen uptake (VO2) maximum via symptom limited exercise testing
14 secondary outcomes
Perceived Fatigability
Time frame: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks
Bioenergetics: In-Vivo 31P MRS Respirations
Time frame: Week 3 (pre drug) to week 10(post drug); approx. 8 weeks
Bioenergetics: Ex-Vivo Mitochondrial Respiration Analysis
Time frame: Week 5 (pre-drug) to week 16 (post-drug); approx. 8 weeks
Exercise-induced Changes in Pulmonary Arterial Pressure
Time frame: Week 3 (pre-drug) to week 10 (post drug); approx 8 weeks
Exercise-induced Changes in Pulmonary Capillary Wedge Pressure
Time frame: Week 3 (pre-drug) to week 10 (post drug); approx 8 weeks
Patients With Pulmonary Hypertension
Time frame: Week 3 (pre-drug) to week 10 (post drug); approx 8 weeks
Steps From Accelerometry Assessment of Daily Activity
Time frame: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Sedentary Events From Accelerometry Assessment of Daily Activity
Time frame: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Light Activity Duration From Accelerometry Assessment of Daily Activity
Time frame: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Moderate to Vigorous Physical Activity From Accelerometry Assessment of Daily Activity
Time frame: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Vector Magnitude Counts From Accelerometry Assessment of Daily Activity
Time frame: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Sedentary Event Duration From Accelerometry Assessment of Daily Activity
Time frame: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Light Activity Events Percentage of Day From Accelerometry Assessment of Daily Activity
Time frame: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Moderate to Vigorous Physical Activity Percentage From Accelerometry Assessment of Daily Activity
Time frame: Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with other future investigators as research questions arise.
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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.
Daniel E Forman, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sodium nitrite in people with Heart Failure, run by Gladwin, Mark, MD at 1 site in United States.
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 9 inclusion and 20 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: finished, as of the sponsor's last update on 22 Jan 2020. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory Fitness (time frame: Week 2(pre drug) to Week 10( post drug); approx. 8 weeks). 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 22 Jan 2020.