HypertensionNCT06247774
Reducing Heart Failure Risk in Late-Life With Physical Activity
A study testing Cardiac Rehabilitation in people with Hypertension and Exercise Training, run by Brigham and Women's Hospital.
Trial 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 don't already participate in regular exercise. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Exercise Training, Cardiac Rehabilitation
- What is being tested?
- Cardiac Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to May 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Hypertension (controlled on stable medication regimen)
- Structural heart abnormality (LVH or LA enlargement)
- LVEF > 50%
- Sedentary
- BMI <30
Who cannot join
- Diabetes
- Unable to exercise
- Supplemental oxygen use
- Pulmonary hypertension
- Sleep apnea
- Regular exercise training
Show all 12Show fewer
- Devices that limit ability to achieve target heart rate
- Moderate to severe valve disease
- Recent (within 3 months) major CV event or planned procedures (within 6 months)
- Terminal illness, life expectancy <6 months
- Inability or unwillingness to comply with study requirements
- No access to smart phone/tablet
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reducing Heart Failure Risk in Late-Life With Physical Activity: Impact on Cardiac Structure and Function and Proteomic Signatures
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 don't 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.
Read more
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 don't participate in the exercise program.
Read the 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 (n=228) 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.
- Conditions
- Hypertension, Exercise Training, Cardiac Rehabilitation, Proteomics
- Being tested
- Cardiac Rehabilitation, Attention Control
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac RehabilitationBehavioural
Participation in a 12-week cardiac rehabilitation program
Attention ControlBehavioural
Participants will receive regular phone calls in place of cardiac rehabilitation visits
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation | Experimental | Participants will participate in a 12-week cardiac rehabilitation program Receives: Behavioral: Cardiac Rehabilitation |
| Attention Control | Placebo comparator | Participants will not participate in a cardiac rehabilitation program and will receive phone calls in place of cardiac rehabilitation visits. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Cardiac Rehabilitation training on single protein changes
Change in protein levels assessed by blood draws and measured by Somascan assay. ANCOVA analysis adjusting for baseline protein levels with intention to treat group assignment
Measured: 12 weeks
Secondary outcomes (18)
Correlation of change in proteins with change in VO2 max
Correlation of single protein changes associated with change in VO2 max
Measured: 12 weeks
Correlation of change in proteins with change in LV global longitudinal strain
Correlation of single protein changes associated with change in LV global longitudinal strain
Measured: 12 weeks
Correlation of change in proteins with change in LV diastolic function
Correlation of single protein changes associated with change in LV diastolic function
Measured: 12 weeks
Correlation of change in proteins with change in VE/VCO2
Correlation of single protein changes associated with change in VE/VCO2
Measured: 12 weeks
Correlation of change in proteins with change in Short Physical Performance Battery (SPPB)
Correlation of single protein changes associated with change in Short Physical Performance Battery (SPPB)
Measured: 12 weeks
Correlation of change in proteins with change in 6-minute walk test
Correlation of single protein changes associated with change in 6-minute walk test
Measured: 12 weeks
Correlation of change in proteins with change in grip strength
Correlation of single protein changes associated with change in grip strength
Measured: 12 weeks
Correlation of change in proteins with change in EQ-5D (QOL)
Correlation of single protein changes associated with change in EQ-5D (QOL)
Measured: 12 weeks
Correlation of change in proteins with change in step counts
Correlation of single protein changes associated with change in step counts
Measured: 12 weeks
Correlation of baseline proteins with change in VO2 max
Correlation of baseline proteins with change in VO2 max
Measured: 12 weeks
Correlation of baseline proteins with change in LV global longitudinal strain
Correlation of baseline proteins with change in LV global longitudinal strain
Measured: 12 weeks
Correlation of baseline proteins with change in LV diastolic function
Correlation of baseline proteins with change in LV diastolic function
Measured: 12 weeks
Correlation of baseline proteins with change in VE/VCO2
Correlation of baseline proteins with change in VE/VCO2
Measured: 12 weeks
Correlation of baseline proteins with change in SPPB
Correlation of baseline proteins with change in SPPB
Measured: 12 weeks
Correlation of baseline proteins with change in 6-minute walk test
Correlation of baseline proteins with change in 6-minute walk test
Measured: 12 weeks
Correlation of baseline proteins with change in grip strength
Correlation of baseline proteins with change in grip strength
Measured: 12 weeks
Correlation of baseline proteins with change in EQ-5D (QOL)
Correlation of baseline proteins with change in EQ-5D (QOL)
Measured: 12 weeks
Correlation of baseline proteins with change in step counts
Correlation of baseline proteins with change in step counts
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study startJun 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheila M. Hegde, MD, Brigham and Women's Hospital
- Investigators
- Sheila Hegde, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247774
- Sponsor's protocol ID
- 2023p002781
- Status last verified
- Nov 2025
- First submitted
- 23 Jan 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ngo D, Sinha S, Shen D, Kuhn EW, Keyes MJ, Shi X, Benson MD, O'Sullivan JF, Keshishian H, Farrell LA, Fifer MA, Vasan RS, Sabatine MS, Larson MG, Carr SA, Wang TJ, Gerszten RE. Aptamer-Based Proteomic Profiling Reveals Novel Candidate Biomarkers and Pathways in Cardiovascular Disease. Circulation. 2016 Jul 26;134(4):270-85. doi: 10.1161/CIRCULATIONAHA.116.021803.
PubMed 27444932Jacob J, Ngo D, Finkel N, Pitts R, Gleim S, Benson MD, Keyes MJ, Farrell LA, Morgan T, Jennings LL, Gerszten RE. Application of Large-Scale Aptamer-Based Proteomic Profiling to Planned Myocardial Infarctions. Circulation. 2018 Mar 20;137(12):1270-1277. doi: 10.1161/CIRCULATIONAHA.117.029443. Epub 2017 Dec 8.
PubMed 29222138Wallentin L, Eriksson N, Olszowka M, Grammer TB, Hagstrom E, Held C, Kleber ME, Koenig W, Marz W, Stewart RAH, White HD, Aberg M, Siegbahn A. Plasma proteins associated with cardiovascular death in patients with chronic coronary heart disease: A retrospective study. PLoS Med. 2021 Jan 13;18(1):e1003513. doi: 10.1371/journal.pmed.1003513. eCollection 2021 Jan.
PubMed 33439866Sanders-van Wijk S, Tromp J, Beussink-Nelson L, Hage C, Svedlund S, Saraste A, Swat SA, Sanchez C, Njoroge J, Tan RS, Fermer ML, Gan LM, Lund LH, Lam CSP, Shah SJ. Proteomic Evaluation of the Comorbidity-Inflammation Paradigm in Heart Failure With Preserved Ejection Fraction: Results From the PROMIS-HFpEF Study. Circulation. 2020 Nov 24;142(21):2029-2044. doi: 10.1161/CIRCULATIONAHA.120.045810. Epub 2020 Oct 9.
PubMed 33034202Santos-Parker JR, Santos-Parker KS, McQueen MB, Martens CR, Seals DR. Habitual aerobic exercise and circulating proteomic patterns in healthy adults: relation to indicators of healthspan. J Appl Physiol (1985). 2018 Nov 1;125(5):1646-1659. doi: 10.1152/japplphysiol.00458.2018. Epub 2018 Sep 20.
PubMed 30236049Stattin K, Lind L, Elmstahl S, Wolk A, Lemming EW, Melhus H, Michaelsson K, Byberg L. Physical activity is associated with a large number of cardiovascular-specific proteins: Cross-sectional analyses in two independent cohorts. Eur J Prev Cardiol. 2019 Nov;26(17):1865-1873. doi: 10.1177/2047487319868033. Epub 2019 Aug 14.
PubMed 31409108Contrepois 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 32470399Robbins JM, Peterson B, Schranner D, Tahir UA, Rienmuller T, Deng S, Keyes MJ, Katz DH, Beltran PMJ, Barber JL, Baumgartner C, Carr SA, Ghosh S, Shen C, Jennings LL, Ross R, Sarzynski MA, Bouchard C, Gerszten RE. Human plasma proteomic profiles indicative of cardiorespiratory fitness. Nat Metab. 2021 Jun;3(6):786-797. doi: 10.1038/s42255-021-00400-z. Epub 2021 May 27.
PubMed 34045743Shah AM, Claggett B, Loehr LR, Chang PP, Matsushita K, Kitzman D, Konety S, Kucharska-Newton A, Sueta CA, Mosley TH, Wright JD, Coresh J, Heiss G, Folsom AR, Solomon SD. Heart Failure Stages Among Older Adults in the Community: The Atherosclerosis Risk in Communities Study. Circulation. 2017 Jan 17;135(3):224-240. doi: 10.1161/CIRCULATIONAHA.116.023361. Epub 2016 Nov 23.
PubMed 27881564Hieda M, Sarma S, Hearon CM Jr, Dias KA, Martinez J, Samels M, Everding B, Palmer D, Livingston S, Morris M, Howden E, Levine BD. Increased Myocardial Stiffness in Patients With High-Risk Left Ventricular Hypertrophy: The Hallmark of Stage-B Heart Failure With Preserved Ejection Fraction. Circulation. 2020 Jan 14;141(2):115-123. doi: 10.1161/CIRCULATIONAHA.119.040332. Epub 2019 Dec 23.
PubMed 31865771Hieda M, Sarma S, Hearon CM Jr, MacNamara JP, Dias KA, Samels M, Palmer D, Livingston S, Morris M, Levine BD. One-Year Committed Exercise Training Reverses Abnormal Left Ventricular Myocardial Stiffness in Patients With Stage B Heart Failure With Preserved Ejection Fraction. Circulation. 2021 Sep 21;144(12):934-946. doi: 10.1161/CIRCULATIONAHA.121.054117. Epub 2021 Sep 20.
PubMed 34543068O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Pina IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454.
PubMed 19351941Whellan DJ, O'Connor CM, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Houston-Miller N, Fleg JL, Schulman KA, Pina IL; HF-ACTION Trial Investigators. Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. Am Heart J. 2007 Feb;153(2):201-11. doi: 10.1016/j.ahj.2006.11.007.
PubMed 17239677Bozkurt B, Fonarow GC, Goldberg LR, Guglin M, Josephson RA, Forman DE, Lin G, Lindenfeld J, O'Connor C, Panjrath G, Pina IL, Shah T, Sinha SS, Wolfel E; ACC's Heart Failure and Transplant Section and Leadership Council. Cardiac Rehabilitation for Patients With Heart Failure: JACC Expert Panel. J Am Coll Cardiol. 2021 Mar 23;77(11):1454-1469. doi: 10.1016/j.jacc.2021.01.030.
PubMed 33736829Keteyian SJ, Ades PA, Beatty AL, Gavic-Ott A, Hines S, Lui K, Schopfer DW, Thomas RJ, Sperling LS. A Review of the Design and Implementation of a Hybrid Cardiac Rehabilitation Program: AN EXPANDING OPPORTUNITY FOR OPTIMIZING CARDIOVASCULAR CARE. J Cardiopulm Rehabil Prev. 2022 Jan 1;42(1):1-9. doi: 10.1097/HCR.0000000000000634.
PubMed 34433760
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Heart Failure Risk in Late-Life With Physical Activity: Impact on Cardiac Structure and Function and Proteomic Signatures
- ClinicalTrials.gov ID
- NCT06247774
- Acronym / sponsor ID
- 2023p002781
- Conditions
- Hypertension, Exercise Training, Cardiac Rehabilitation, Proteomics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 8 Feb 2024 (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 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 don't 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 don't 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 (n=228) 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation | Experimental | Behavioral: Cardiac RehabilitationParticipants will participate in a 12-week cardiac rehabilitation program |
| Attention Control | Placebo comparator | Behavioral: Attention ControlParticipants will not participate in a cardiac rehabilitation program and will receive phone calls in place of cardiac rehabilitation visits. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Hypertension (controlled on stable medication regimen)
- Structural heart abnormality (LVH or LA enlargement)
- LVEF > 50%
- Sedentary
- BMI <30
Key exclusion criteria (12 listed)
- Diabetes
- Unable to exercise
- Supplemental oxygen use
- Pulmonary hypertension
- Sleep apnea
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 |
|---|---|---|
| Cardiac RehabilitationParticipation in a 12-week cardiac rehabilitation program | Behavioural | Cardiac Rehabilitation |
| Attention ControlParticipants will receive regular phone calls in place of cardiac rehabilitation visits | Behavioural | Attention Control |
Primary outcome
Impact of Cardiac Rehabilitation training on single protein changes
Time frame: 12 weeks
Change in protein levels assessed by blood draws and measured by Somascan assay. ANCOVA analysis adjusting for baseline protein levels with intention to treat group assignment
18 secondary outcomes
Correlation of change in proteins with change in VO2 max
Time frame: 12 weeks
Correlation of change in proteins with change in LV global longitudinal strain
Time frame: 12 weeks
Correlation of change in proteins with change in LV diastolic function
Time frame: 12 weeks
Correlation of change in proteins with change in VE/VCO2
Time frame: 12 weeks
Correlation of change in proteins with change in Short Physical Performance Battery (SPPB)
Time frame: 12 weeks
Correlation of change in proteins with change in 6-minute walk test
Time frame: 12 weeks
Correlation of change in proteins with change in grip strength
Time frame: 12 weeks
Correlation of change in proteins with change in EQ-5D (QOL)
Time frame: 12 weeks
Correlation of change in proteins with change in step counts
Time frame: 12 weeks
Correlation of baseline proteins with change in VO2 max
Time frame: 12 weeks
Correlation of baseline proteins with change in LV global longitudinal strain
Time frame: 12 weeks
Correlation of baseline proteins with change in LV diastolic function
Time frame: 12 weeks
Correlation of baseline proteins with change in VE/VCO2
Time frame: 12 weeks
Correlation of baseline proteins with change in SPPB
Time frame: 12 weeks
Correlation of baseline proteins with change in 6-minute walk test
Time frame: 12 weeks
Correlation of baseline proteins with change in grip strength
Time frame: 12 weeks
Correlation of baseline proteins with change in EQ-5D (QOL)
Time frame: 12 weeks
Correlation of baseline proteins with change in step counts
Time frame: 12 weeks
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 12 Mar 2026.
- Background: PubMed 27444932Ngo D, Sinha S, Shen D, Kuhn EW, Keyes MJ, Shi X, Benson MD, O'Sullivan JF, Keshishian H, Farrell LA, Fifer MA, Vasan RS, Sabatine MS, Larson MG, Carr SA, Wang TJ, Gerszten RE. Aptamer-Based Proteomic Profiling Reveals Novel Candidate Biomarkers and Pathways in Cardiovascular Disease. Circulation. 2016 Jul 26;134(4):270-85. doi: 10.1161/CIRCULATIONAHA.116.021803.
- Background: PubMed 29222138Jacob J, Ngo D, Finkel N, Pitts R, Gleim S, Benson MD, Keyes MJ, Farrell LA, Morgan T, Jennings LL, Gerszten RE. Application of Large-Scale Aptamer-Based Proteomic Profiling to Planned Myocardial Infarctions. Circulation. 2018 Mar 20;137(12):1270-1277. doi: 10.1161/CIRCULATIONAHA.117.029443. Epub 2017 Dec 8.
- Background: PubMed 33439866Wallentin L, Eriksson N, Olszowka M, Grammer TB, Hagstrom E, Held C, Kleber ME, Koenig W, Marz W, Stewart RAH, White HD, Aberg M, Siegbahn A. Plasma proteins associated with cardiovascular death in patients with chronic coronary heart disease: A retrospective study. PLoS Med. 2021 Jan 13;18(1):e1003513. doi: 10.1371/journal.pmed.1003513. eCollection 2021 Jan.
- Background: PubMed 33034202Sanders-van Wijk S, Tromp J, Beussink-Nelson L, Hage C, Svedlund S, Saraste A, Swat SA, Sanchez C, Njoroge J, Tan RS, Fermer ML, Gan LM, Lund LH, Lam CSP, Shah SJ. Proteomic Evaluation of the Comorbidity-Inflammation Paradigm in Heart Failure With Preserved Ejection Fraction: Results From the PROMIS-HFpEF Study. Circulation. 2020 Nov 24;142(21):2029-2044. doi: 10.1161/CIRCULATIONAHA.120.045810. Epub 2020 Oct 9.
- Background: PubMed 30236049Santos-Parker JR, Santos-Parker KS, McQueen MB, Martens CR, Seals DR. Habitual aerobic exercise and circulating proteomic patterns in healthy adults: relation to indicators of healthspan. J Appl Physiol (1985). 2018 Nov 1;125(5):1646-1659. doi: 10.1152/japplphysiol.00458.2018. Epub 2018 Sep 20.
- Background: PubMed 31409108Stattin K, Lind L, Elmstahl S, Wolk A, Lemming EW, Melhus H, Michaelsson K, Byberg L. Physical activity is associated with a large number of cardiovascular-specific proteins: Cross-sectional analyses in two independent cohorts. Eur J Prev Cardiol. 2019 Nov;26(17):1865-1873. doi: 10.1177/2047487319868033. Epub 2019 Aug 14.
- 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.
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- Background: PubMed 27881564Shah AM, Claggett B, Loehr LR, Chang PP, Matsushita K, Kitzman D, Konety S, Kucharska-Newton A, Sueta CA, Mosley TH, Wright JD, Coresh J, Heiss G, Folsom AR, Solomon SD. Heart Failure Stages Among Older Adults in the Community: The Atherosclerosis Risk in Communities Study. Circulation. 2017 Jan 17;135(3):224-240. doi: 10.1161/CIRCULATIONAHA.116.023361. Epub 2016 Nov 23.
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- 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.
Sheila Hegde, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Rehabilitation in people with Hypertension and Exercise Training, run by Brigham and Women's Hospital.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact Sheila Hegde, MD (6177325500, shegde@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Cardiac Rehabilitation training on single protein changes (time frame: 12 weeks). 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 NCT06247774, which also lists 17 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 12 Mar 2026.