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Identifying Markers of Exercise Training in Heart Failure

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac rehabilitation
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Heart Failure

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Be 18-89 years of age Not be pregnant or lactating in the last 12 months, or planning to become pregnant for the next 4 months. A pregnancy test will be performed on the day of DXA scan in women of child-bearing potential. Not be post-partum during the last 12 months. patients must carry a diagnosis of heart failure with ejection fraction < 40% Be willing to provide informed consent for all study procedures be willing to participate in cardiac rehabilitation Exclusion Criteria: Diabetes (self-report and screening tests), which includes: i) treatment with any hypoglycemic agents (self-report, even for non-diabetic reasons) or ii) fasting glucose >125 or A1c >6.4 (screening test). Chronic renal insufficiency (screening test): estimated glomerular filtration rate <60 mL/min/1.73 m2 from serum creatinine (mg/dL) by the Chronic Kidney Disease Epidemiology Collaboration equation Individuals receiving any active treatment for autoimmune disorders (including monoclonal antibodies) within the last 6 months. Alcohol consumption (self-report): i) more than 7 drinks per week for women and more than 14 drinks per week for men; ii) history of binge drinking. Hospitalization for any psychiatric condition within one year (self-report). 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. Mental incapacity and/or cognitive impairment on the part of the participant that would inhibit adequate understanding of or cooperation with the study protocol. Taking Androgenic anabolic steroids, anti-estrogens, anti-androgens Taking Growth hormone, insulin like growth factor-I, growth hormone releasing hormone Taking Any drugs used to treat diabetes mellitus or to lower blood glucose Taking Any drugs used specifically to induce weight loss Taking Any drugs used specifically to induce muscle growth/hypertrophy or augment exercise-induced muscle hypertrophy Taking Narcotics and narcotic receptor agonists Taking Monoclonal antibodies Taking Any other medications that, in the opinion of local clinicians, would negatively impact or mitigate full participation and completion.

Sites / Locations

  • Stanford Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

12 weeks Cardiac Rehabilitation

Standard of Care

Arm Description

Participants will be randomized to either immediate entry to cardiac rehabilitation, or no intervention (their clinical cardiac rehabilitation will be delayed during the 12 weeks of the study)

Participants will be randomized to either immediate entry to cardiac rehabilitation, or no intervention (their clinical cardiac rehabilitation will be delayed during the 12 weeks of the study)

Outcomes

Primary Outcome Measures

Change in 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.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2023
Last Updated
January 13, 2023
Sponsor
Stanford University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05696652
Brief Title
Identifying Markers of Exercise Training in Heart Failure
Official Title
Identifying Markers of Exercise Training in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. Cardiac rehabilitation been shown to improve symptoms for heart failure patients. However, we do not know exactly what exercise does to the molecules that make up the human body. If we could answer this question, we might find a whole new way to treat the symptoms of heart failure. Therefore we 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 we know the proteins that change with exercise, we 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
12 weeks Cardiac Rehabilitation
Arm Type
Experimental
Arm Description
Participants will be randomized to either immediate entry to cardiac rehabilitation, or no intervention (their clinical cardiac rehabilitation will be delayed during the 12 weeks of the study)
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Participants will be randomized to either immediate entry to cardiac rehabilitation, or no intervention (their clinical cardiac rehabilitation will be delayed during the 12 weeks of the study)
Intervention Type
Behavioral
Intervention Name(s)
Cardiac rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Proteomic Profile
Description
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.
Time Frame
Baseline vs week 12 proteomic profile

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be 18-89 years of age Not be pregnant or lactating in the last 12 months, or planning to become pregnant for the next 4 months. A pregnancy test will be performed on the day of DXA scan in women of child-bearing potential. Not be post-partum during the last 12 months. patients must carry a diagnosis of heart failure with ejection fraction < 40% Be willing to provide informed consent for all study procedures be willing to participate in cardiac rehabilitation Exclusion Criteria: Diabetes (self-report and screening tests), which includes: i) treatment with any hypoglycemic agents (self-report, even for non-diabetic reasons) or ii) fasting glucose >125 or A1c >6.4 (screening test). Chronic renal insufficiency (screening test): estimated glomerular filtration rate <60 mL/min/1.73 m2 from serum creatinine (mg/dL) by the Chronic Kidney Disease Epidemiology Collaboration equation Individuals receiving any active treatment for autoimmune disorders (including monoclonal antibodies) within the last 6 months. Alcohol consumption (self-report): i) more than 7 drinks per week for women and more than 14 drinks per week for men; ii) history of binge drinking. Hospitalization for any psychiatric condition within one year (self-report). 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. Mental incapacity and/or cognitive impairment on the part of the participant that would inhibit adequate understanding of or cooperation with the study protocol. Taking Androgenic anabolic steroids, anti-estrogens, anti-androgens Taking Growth hormone, insulin like growth factor-I, growth hormone releasing hormone Taking Any drugs used to treat diabetes mellitus or to lower blood glucose Taking Any drugs used specifically to induce weight loss Taking Any drugs used specifically to induce muscle growth/hypertrophy or augment exercise-induced muscle hypertrophy Taking Narcotics and narcotic receptor agonists Taking Monoclonal antibodies Taking Any other medications that, in the opinion of local clinicians, would negatively impact or mitigate full participation and completion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel H Katz, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Health Care
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32589957
Citation
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.
Results Reference
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PubMed Identifier
32470399
Citation
Contrepois 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.
Results Reference
background

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Identifying Markers of Exercise Training in Heart Failure

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