Heart FailureNCT05696652
Identifying Markers of Exercise Training in Heart Failure
A study testing Acute exercise and Cardiac rehabilitation in people with Heart Failure, run by Stanford University at 1 site in United States.
Trial summary
The heart failure syndrome that occurs when the heart is too sick to properly do its job. One of the main symptoms is difficulty with exercise. One way to improve symptoms is to start patients in a 12 week exercise program called cardiac rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Acute exercise and Cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2024to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-89
- Patients must carry a diagnosis of heart failure with ejection fraction < 40%
- Be willing to participate in cardiac rehabilitation, and not already done so in the last year
- Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
- Must be able to exercise on a treadmill
Who cannot join
- Inability to complete CPET or participate in CR (verbal/chart)
- Syncope during CPET within the last 6 mos, sustained VT on CPET, hemodynamically significant arrhythmia during CPET (verbal/chart)
- BMI >= 38 (verbal/chart)
- History of a bleeding disorder or clotting abnormality (verbal/chart)
- Clinical diagnosis of severe Chronic Obstructive Pulmonary Disease (COPD) (verbal/chart)
- History of malignancy not considered in remission (verbal/chart)
Show all 56Show fewer
- Cirrhosis (verbal/chart)
- Thyroid disease (verbal/chart)
- Thyroid Stimulating Hormone (TSH) value outside of the normal range for the laboratory within the last 1 year
- Individuals with hypothyroidism may be referred to their primary care provider (PCP) for evaluation and retested; any medication change must be stable for ≥3 months prior to retesting
- Individuals with hyperthyroidism are excluded, including those with normal TSH on pharmacologic treatment
- Cancer (verbal/chart)
- History of cancer treatment (other than non-melanoma skin cancer) and not "cancer-free" for at least 2 years
- Anti-hormonal therapy (e.g., for breast or prostate cancer) within the last 6 months
- Chronic active or latent infection (verbal/chart)
- Active or latent infections requiring chronic antibiotic or anti-viral treatment
- Chronic active infection whether on chronic antimicrobials or not
- Human Immunodeficiency Virus
- Active hepatitis B or C undergoing antiviral therapy
- Individuals successfully treated for hepatitis C and virologically negative for at least 6 months are not excluded
- Tobacco (verbal/chart)
- Current smokers: any tobacco or e-cigarette/e-nicotine products
- Former smokers: Stopped smoking <6 months at time of screening
- Not be pregnant or lactating in the last 12 months, or planning to become pregnant for the next 4 months. Not be post-partum during the last 12 months. (verbal/chart)
- Metabolic bone disease (self-report): History of non-traumatic fracture from a standing height or less. Current pharmacologic treatment for low bone mass or osteoporosis, other than calcium, vitamin D, or estrogen. (verbal/chart)
- Diabetes (self-report and screening), which includes: i) treatment with any insulin or ii) A1c >=8.0 (screening). (verbal/chart)
- Chronic renal insufficiency (screening): estimated glomerular filtration rate <30 mL/min/1.73 m2 from serum creatinine (mg/dL) by the Chronic Kidney Disease Epidemiology Collaboration equation. (verbal/chart)
- Individuals receiving any active treatment for autoimmune disorders (including monoclonal antibodies) within the last 6 months. (verbal/chart)
- Alcohol consumption: i) more than 7 drinks per week for women and more than 14 drinks per week for men; ii) history of binge drinking. (verbal/chart)
- Any individual engaging in night shift work in the last 6 months.
- Hospitalization for any psychiatric condition within one year (verbal/chart)
- Any musculoskeletal or ligamentous injury, amputation or congenital neurological defect that, in the opinion of the team clinician, would negatively impact or mitigate participation in and completion of the protocol. (verbal/chart)
- Mental incapacity and/or cognitive impairment on the part of the participant that would inhibit adequate understanding of or cooperation with the study protocol
- Other (clinician judgment)
- Genetic metabolic disorders that could affect metabolomic results (e.g., phenylketonuria)
- Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, metabolic, or other conditions that, in the opinion of the local clinician, would preclude participation and successful completion of the protocol
- Any other illnesses that, in the opinion of the local clinician, would negatively impact or mitigate participation in and completion of the protocol
- Medication exclusions (chart review)
- Androgenic anabolic steroids, antiestrogens, antiandrogens
- Growth hormone, insulin like growth factor, growth hormone releasing hormone
- Insulin of any type used regularly
- Any drugs used specifically to induce muscle growth/hypertrophy or augment exercise induced muscle hypertrophy
- Psychiatric
- Chronic use of medium- or long-acting sedatives and hypnotics, including all benzodiazepines; short-acting non-benzodiazepine sedative-hypnotics are allowed
- Two or more drugs for depression
- Mood stabilizers
- Antiepileptic drugs
- Stimulants, Attention-Deficit/Hyperactivity Disorder (ADHD) drugs
- Anti-psychotic drugs
- Narcotics and narcotic receptor agonists
- Chronic systemic antimicrobials (antibiotic, antiviral, antifungal, antiparasite, etc) for any reason
- High-potency topical steroids if ≥10% of surface area using rule of 9s
- Continuous/chronic use of antibiotics or other anti-infectives for treatment or prevention
- Monoclonal antibodies
- Anti-rejection medications/immune suppressants
- Any other medications that, in the opinion of local clinicians, would negatively impact or mitigate full participation and completion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Health Care
Stanford, California, 94305
Mia Levanto, 650-498-5673, motrx-hf-shc@stanford.edu
About this study
The heart failure syndrome that occurs when the heart is too sick to properly do its job. One of the main symptoms is difficulty with exercise. One way to improve symptoms is to start patients in a 12 week exercise program called cardiac rehabilitation. Cardiac rehabilitation been shown to improve symptoms for heart failure patients. However, the investigators do not know exactly what exercise does to the molecules that make up the human body. If the investigators could answer this question, the investigators might find a whole new way to treat the symptoms of heart failure. Therefore the investigators want to know what molecules might be responsible for the benefits of exercise. The plan for this study is to measure the levels of thousands of proteins in blood samples which come from people with heart failure and see how those levels change after 12 weeks of cardiac rehabilitation, compared to the protein levels in patients whose cardiac rehabilitation is delayed until after the study period. If the investigators know the proteins that change with exercise, the investigators can then look to see if targeting these proteins with medicines can mimic the benefits of exercise. The long term goal of our work is to identify "exercise-in-a-pill" medicines that will help people with heart failure.
- Conditions
- Heart Failure
- Being tested
- Acute exercise, Cardiac rehabilitation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute exerciseBehavioural
40 minute moderate intensity exercise bout on a treadmill. This is similar to a single session of cardiac rehabilitation.
Cardiac rehabilitationBehavioural
12 week program of standard clinical cardiac rehabilitation for patients with symptomatic heart failure. Patients undergo 3-times weekly sessions of monitored exercise for 12 weeks. This is the same cardiac rehabilitation patients would get as part of clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Active arm: Acute exercise | Experimental | This arm includes two-thirds of enrollees and focuses on acute effects of exercise. Qualifying participants with heart failure randomized to this arm will undergo a 40 minute bout of moderate intensity exercise. Blood samples will be collected before and after the acute bout at 10, 30, and 210 minutes after exercise. Receives: Behavioral: Acute exercise |
| Control arm: No exercise (Acute Comparison) | No intervention | This arm includes one-third of enrollees and serves as control. Qualifying participants with heart failure randomized to this arm will begin with a 40 minute period of rest. Blood samples will be collected before and after the the 40 minute period at 10, 30, and 210 minutes after the start. |
| Active Arm: 12 weeks Cardiac Rehabilitation | Experimental | This arm includes two-thirds of enrollees for the training intervention and focuses on chronic effects of exercise. Participants have a baseline blood sample and then go to cardiac rehabilitation for a 12 week period. A single blood sample will be obtained at 6 weeks. The participants will return after the 12 weeks of cardiac rehabilitation for another single blood sample. Receives: Behavioral: Cardiac rehabilitation |
| Control: No Exercise (Training) | No intervention | Participants receive baseline fasting blood sample and then defer cardiac rehabilitation for a 12 week period. A single blood sample will be obtained at 6 weeks of this control intervention period. 12 weeks after enrollment, patients will return for another single blood sample. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Proteomic Profile: Chronic
Patients will have proteomic profiling performed at baseline, prior to the intervention period, and again following the 12 week intervention. Proteomic profiling measures levels of ~3000 proteins in the blood, so the changes in the global proteome can be assessed after the intervention period.
Measured: Baseline vs week 12 proteomic profile
Change in Proteomic Profile: Acute
Patients will have proteomic profiling performed at baseline, prior to the acute bout of exercise, and again following the 12 week intervention. Proteomic profiling measures levels of ~3000 proteins in the blood, so the changes in the global proteome can be assessed before and after the acute exercise bout. Comparisons can be drawn between between those exercising and those not exercising (at acute bout #1), but also can be compared between those who did and did not not undergo cardiac rehabilitation (at acute bout #2).
Measured: Acute bout vs control; Baseline vs week 12 proteomic profile of acute exercise
Secondary outcomes (1)
Proteomic predictors of Cardiopulmonary fitness
Participants will have cardiopulmonary exercise testing at baseline and after 12 weeks to assess the effects of cardiac rehab. The association between cardiopulmonary fitness metrics and proteomic profile will be assessed
Measured: Baseline vs week 12 proteomic profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start20 Mar 2024
- Primary completion26 May 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Heart Association
- Responsible party
- Principal investigator, Daniel Katz, Stanford University
- Investigators
- Daniel H Katz, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696652
- Sponsor's protocol ID
- 68827
- Other IDs
- 5K23HL164980-02, 23CDA1040581
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2023
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanford JA, Nogiec CD, Lindholm ME, Adkins JN, Amar D, Dasari S, Drugan JK, Fernandez FM, Radom-Aizik S, Schenk S, Snyder MP, Tracy RP, Vanderboom P, Trappe S, Walsh MJ; Molecular Transducers of Physical Activity Consortium. Molecular Transducers of Physical Activity Consortium (MoTrPAC): Mapping the Dynamic Responses to Exercise. Cell. 2020 Jun 25;181(7):1464-1474. doi: 10.1016/j.cell.2020.06.004.
PubMed 32589957Contrepois K, Wu S, Moneghetti KJ, Hornburg D, Ahadi S, Tsai MS, Metwally AA, Wei E, Lee-McMullen B, Quijada JV, Chen S, Christle JW, Ellenberger M, Balliu B, Taylor S, Durrant MG, Knowles DA, Choudhry H, Ashland M, Bahmani A, Enslen B, Amsallem M, Kobayashi Y, Avina M, Perelman D, Schussler-Fiorenza Rose SM, Zhou W, Ashley EA, Montgomery SB, Chaib H, Haddad F, Snyder MP. Molecular Choreography of Acute Exercise. Cell. 2020 May 28;181(5):1112-1130.e16. doi: 10.1016/j.cell.2020.04.043.
PubMed 32470399
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Markers of Exercise Training in Heart Failure
- ClinicalTrials.gov ID
- NCT05696652
- Acronym / sponsor ID
- 68827
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Heart Association
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 26 May 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 25 Jan 2023 (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 heart failure syndrome that occurs when the heart is too sick to properly do its job. One of the main symptoms is difficulty with exercise. One way to improve symptoms is to start patients in a 12 week exercise program called cardiac rehabilitation. Cardiac rehabilitation been shown to improve symptoms for heart failure patients. However, the investigators do not know exactly what exercise does to the molecules that make up the human body. If the investigators could answer this question, the investigators might find a whole new way to treat the symptoms of heart failure. Therefore the investigators want to know what molecules might be responsible for the benefits of exercise. The plan for this study is to measure the levels of thousands of proteins in blood samples which come from people with heart failure and see how those levels change after 12 weeks of cardiac rehabilitation, compared to the protein levels in patients whose cardiac rehabilitation is delayed until after the study period. If the investigators know the proteins that change with exercise, the investigators can then look to see if targeting these proteins with medicines can mimic the benefits of exercise. The long term goal of our work is to identify "exercise-in-a-pill" medicines that will help people with heart failure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active arm: Acute exercise | Experimental | Behavioral: Acute exerciseThis arm includes two-thirds of enrollees and focuses on acute effects of exercise. Qualifying participants with heart failure randomized to this arm will undergo a 40 minute bout of moderate intensity exercise. Blood samples will be collected before and after the acute bout at 10, 30, and 210 minutes after exercise. |
| Control arm: No exercise (Acute Comparison) | No intervention | –This arm includes one-third of enrollees and serves as control. Qualifying participants with heart failure randomized to this arm will begin with a 40 minute period of rest. Blood samples will be collected before and after the the 40 minute period at 10, 30, and 210 minutes after the start. |
| Active Arm: 12 weeks Cardiac Rehabilitation | Experimental | Behavioral: Cardiac rehabilitationThis arm includes two-thirds of enrollees for the training intervention and focuses on chronic effects of exercise. Participants have a baseline blood sample and then go to cardiac rehabilitation for a 12 week period. A single blood sample will be obtained at 6 weeks. The participants will return after the 12 weeks of cardiac rehabilitation for another single blood sample. |
| Control: No Exercise (Training) | No intervention | –Participants receive baseline fasting blood sample and then defer cardiac rehabilitation for a 12 week period. A single blood sample will be obtained at 6 weeks of this control intervention period. 12 weeks after enrollment, patients will return for another single blood sample. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-89
- Patients must carry a diagnosis of heart failure with ejection fraction < 40%
- Be willing to participate in cardiac rehabilitation, and not already done so in the last year
Key exclusion criteria (56 listed)
- Inability to complete CPET or participate in CR (verbal/chart)
- Syncope during CPET within the last 6 mos, sustained VT on CPET, hemodynamically significant arrhythmia during CPET (verbal/chart)
- BMI >= 38 (verbal/chart)
- History of a bleeding disorder or clotting abnormality (verbal/chart)
- Clinical diagnosis of severe Chronic Obstructive Pulmonary Disease (COPD) (verbal/chart)
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 |
|---|---|---|
| Acute exercise40 minute moderate intensity exercise bout on a treadmill. This is similar to a single session of cardiac rehabilitation. | Behavioural | Active arm: Acute exercise |
| Cardiac rehabilitation12 week program of standard clinical cardiac rehabilitation for patients with symptomatic heart failure. Patients undergo 3-times weekly sessions of monitored exercise for 12 weeks. This is the same cardiac rehabilitation patients would get as part of clinical care. | Behavioural | Active Arm: 12 weeks Cardiac Rehabilitation |
Primary outcome
Change in Proteomic Profile: Chronic
Time frame: Baseline vs week 12 proteomic profile
Patients will have proteomic profiling performed at baseline, prior to the intervention period, and again following the 12 week intervention. Proteomic profiling measures levels of ~3000 proteins in the blood, so the changes in the global proteome can be assessed after the intervention period.
Change in Proteomic Profile: Acute
Time frame: Acute bout vs control; Baseline vs week 12 proteomic profile of acute exercise
Patients will have proteomic profiling performed at baseline, prior to the acute bout of exercise, and again following the 12 week intervention. Proteomic profiling measures levels of ~3000 proteins in the blood, so the changes in the global proteome can be assessed before and after the acute exercise bout. Comparisons can be drawn between between those exercising and those not exercising (at acute bout #1), but also can be compared between those who did and did not not undergo cardiac rehabilitation (at acute bout #2).
1 secondary outcome
Proteomic predictors of Cardiopulmonary fitness
Time frame: Baseline vs week 12 proteomic profile
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 32589957Sanford JA, Nogiec CD, Lindholm ME, Adkins JN, Amar D, Dasari S, Drugan JK, Fernandez FM, Radom-Aizik S, Schenk S, Snyder MP, Tracy RP, Vanderboom P, Trappe S, Walsh MJ; Molecular Transducers of Physical Activity Consortium. Molecular Transducers of Physical Activity Consortium (MoTrPAC): Mapping the Dynamic Responses to Exercise. Cell. 2020 Jun 25;181(7):1464-1474. doi: 10.1016/j.cell.2020.06.004.
- Background: PubMed 32470399Contrepois K, Wu S, Moneghetti KJ, Hornburg D, Ahadi S, Tsai MS, Metwally AA, Wei E, Lee-McMullen B, Quijada JV, Chen S, Christle JW, Ellenberger M, Balliu B, Taylor S, Durrant MG, Knowles DA, Choudhry H, Ashland M, Bahmani A, Enslen B, Amsallem M, Kobayashi Y, Avina M, Perelman D, Schussler-Fiorenza Rose SM, Zhou W, Ashley EA, Montgomery SB, Chaib H, Haddad F, Snyder MP. Molecular Choreography of Acute Exercise. Cell. 2020 May 28;181(5):1112-1130.e16. doi: 10.1016/j.cell.2020.04.043.
- Individual participant dataSharing planned: No
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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.
Daniel H Katz, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute exercise and Cardiac rehabilitation in people with Heart Failure, run by Stanford University 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 7 inclusion and 56 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Proteomic Profile: Chronic (time frame: Baseline vs week 12 proteomic profile). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05696652, which also lists 2 linked publications.
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 13 Feb 2026.