Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247774
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-23
Brief Title:
Reducing Heart Failure Risk in Late-Life With Physical Activity
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Reducing Heart Failure Risk in Late-Life With Physical Activity Impact on Cardiac Structure and Function and Proteomic Signatures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn about the molecular pathways associated with the benefit of a regular exercise program in patients with high blood pressure and who dont already participate in regular exercise
The main question it aims to answer is to identify protein signatures associated with the benefits of a cardiac rehabilitation exercise program
The trial will enroll 42 participants who will be randomized to a 12 week cardiac rehabilitation exercise program versus control arm and asked to participate in the following at the beginning and end of study
Cardiopulmonary exercise test CPET
Echocardiogram
Physical function test
6-minute walk test
Hand grip strength
Quality of life questionnaire
Blood draws
Researchers will compare results between those who do and dont participate in the exercise program
The main question it aims to answer is to identify protein signatures associated with the benefits of a cardiac rehabilitation exercise program
The trial will enroll 42 participants who will be randomized to a 12 week cardiac rehabilitation exercise program versus control arm and asked to participate in the following at the beginning and end of study
Cardiopulmonary exercise test CPET
Echocardiogram
Physical function test
6-minute walk test
Hand grip strength
Quality of life questionnaire
Blood draws
Researchers will compare results between those who do and dont participate in the exercise program
Detailed Description:
Lifestyle modification with physical activity PA appears to be protective of several age-related cardiovascular CV outcomes including heart failure HF in a dose-dependent manner While many studies with exercise training have demonstrated improvement in quality of life and cardiorespiratory fitness findings have not been consistent with regards to the potential for exercise to preserve or even improve cardiac function in adults with HF There remains incomplete understanding of the molecular pathways by which PA mitigates HF risk Furthermore exercise studies often exclude older adults who are disproportionately affected by HF though our preliminary data suggest the protective effects of PA extend to late-life Older adults are at particularly heightened risk for HF with preserved ejection fraction HFpEF which is characterized by impaired left ventricular LV diastolic function and impaired systolic deformation despite preserved LV ejection fraction LVEF Unlike with HF with reduced ejection fraction HFrEF effective pharmacologic therapies or interventions to improve cardiac function among individuals with preserved LVEF are limited Thus there is a critical need to define the cardiovascular mechanisms by which PA impacts HF risk in older adults that may enable the identification of novel therapeutic targets to prevent HF and HFpEF in particular
As proteins orchestrate and carry out cellular functions in health and in diseases one method of characterizing changes in CV function is to investigate cell signaling by studying the circulating proteome Proteomic approaches have previously been used to identify pathways relevant to myocardial infarction and have also been used to investigate molecular pathways characterizing PA and CV disease A recent study demonstrated upregulation of inflammation-related proteins in HFpEF patients n228 compared to controls and their association with worse indices of cardiac function Specific proteomic patterns have also been associated with aerobic exercise with 2 proteomic modules that were specifically preserved with aging in habitual exercisers Data from Swedish cohorts has also shown an association of leisure-time PA with 28 CV-specific proteins involved in atherosclerotic processes Serial multi-omic measures including proteomics have been used to demonstrate marked intra-individual changes in circulating proteins with acute exercise More recently high-throughput proteomic profiling has been successfully employed in younger adults to identify baseline protein levels associated with change in cardiorespiratory fitness following an exercise intervention However to-date limited data exist regarding intervention-related changes in the proteome in older adults at risk for HF and the extent to which these changes correlate with changes in cardiorespiratory fitness
Supervised exercise-training with cardiac rehabilitation CR has been well established as an effective method to improve maximal oxygen consumption VO2 max a measure of cardiorespiratory fitness Improvement in VO2 max has also been demonstrated with exercise training in sedentary older adults over 65 years of age
The objective of this proposal is to identify protein signatures characterizing the known benefits of a structured CR program on VO2 max Our working hypotheses is that proteomic approaches will identify novel biomarkers that uniquely characterize molecular pathways associated with exercise training and CR-related changes in proteins will correlate with changes in VO2 max Successful completion of this aim will identify possible novel protein signatures underlying the protective biological pathways mediated by a structured CR program that may be used as preliminary data for future grant proposals
Aim Identify molecular pathways underlying the beneficial effect of a structured PA intervention on functional capacity with the use of plasma proteomics in older sedentary adults at high risk of HF BWH-based cohort Hypotheses 1 Randomization to participation in a cardiac rehabilitation CR program will result in improvement in circulating levels of 4 plasma proteins associated with change in VO2max a measure of cardiorespiratory fitness and with genetic evidence supporting a causal effect on HF and cardiac structure ATF6 STC1 JAG1 PTK7 The investigators will randomize 42 sedentary adults at high risk of HF stage B HF to participation in a CR program and perform proteomic analysis cardiopulmonary exercise testing and echocardiography at baseline and 12 weeks
As proteins orchestrate and carry out cellular functions in health and in diseases one method of characterizing changes in CV function is to investigate cell signaling by studying the circulating proteome Proteomic approaches have previously been used to identify pathways relevant to myocardial infarction and have also been used to investigate molecular pathways characterizing PA and CV disease A recent study demonstrated upregulation of inflammation-related proteins in HFpEF patients n228 compared to controls and their association with worse indices of cardiac function Specific proteomic patterns have also been associated with aerobic exercise with 2 proteomic modules that were specifically preserved with aging in habitual exercisers Data from Swedish cohorts has also shown an association of leisure-time PA with 28 CV-specific proteins involved in atherosclerotic processes Serial multi-omic measures including proteomics have been used to demonstrate marked intra-individual changes in circulating proteins with acute exercise More recently high-throughput proteomic profiling has been successfully employed in younger adults to identify baseline protein levels associated with change in cardiorespiratory fitness following an exercise intervention However to-date limited data exist regarding intervention-related changes in the proteome in older adults at risk for HF and the extent to which these changes correlate with changes in cardiorespiratory fitness
Supervised exercise-training with cardiac rehabilitation CR has been well established as an effective method to improve maximal oxygen consumption VO2 max a measure of cardiorespiratory fitness Improvement in VO2 max has also been demonstrated with exercise training in sedentary older adults over 65 years of age
The objective of this proposal is to identify protein signatures characterizing the known benefits of a structured CR program on VO2 max Our working hypotheses is that proteomic approaches will identify novel biomarkers that uniquely characterize molecular pathways associated with exercise training and CR-related changes in proteins will correlate with changes in VO2 max Successful completion of this aim will identify possible novel protein signatures underlying the protective biological pathways mediated by a structured CR program that may be used as preliminary data for future grant proposals
Aim Identify molecular pathways underlying the beneficial effect of a structured PA intervention on functional capacity with the use of plasma proteomics in older sedentary adults at high risk of HF BWH-based cohort Hypotheses 1 Randomization to participation in a cardiac rehabilitation CR program will result in improvement in circulating levels of 4 plasma proteins associated with change in VO2max a measure of cardiorespiratory fitness and with genetic evidence supporting a causal effect on HF and cardiac structure ATF6 STC1 JAG1 PTK7 The investigators will randomize 42 sedentary adults at high risk of HF stage B HF to participation in a CR program and perform proteomic analysis cardiopulmonary exercise testing and echocardiography at baseline and 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None