Reducing Heart Failure Risk in Late-Life With Physical Activity

NCT06247774 | Not Yet Recruiting DMC

• 1 other identifier: 2023p002781
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Proteomics; Hypertension; Exercise Training; Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (18)

• Correlation of change in proteins with change in VO2 max

  12 weeks

• Correlation of change in proteins with change in LV global longitudinal strain

  12 weeks

• Correlation of change in proteins with change in LV diastolic function

  12 weeks

• Correlation of change in proteins with change in VE/VCO2

  12 weeks

• Correlation of change in proteins with change in Short Physical Performance Battery (SPPB)

  12 weeks

Study Arms (2)

Cardiac Rehabilitation

EXPERIMENTAL

Participants will participate in a 12-week cardiac rehabilitation program

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.

Behavioral: Attention Control

Interventions

Cardiac Rehabilitation BEHAVIORAL

Participation in a 12-week cardiac rehabilitation program

Cardiac Rehabilitation

Attention Control BEHAVIORAL

Participants will receive regular phone calls in place of cardiac rehabilitation visits

Attention Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Hypertension (controlled on stable medication regimen)
• Structural heart abnormality (LVH or LA enlargement)
• LVEF \> 50%
• Sedentary
• BMI \<30

You may not qualify if:

• Diabetes
• Unable to exercise
• Supplemental oxygen use
• Pulmonary hypertension
• Sleep apnea
• Regular exercise training
• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Related Publications (17)

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• Hieda 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.

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MeSH Terms

Conditions

Hypertension

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sheila Hegde, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila Hegde, MD

CONTACT

6177325500; shegde@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 8, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: March 12, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share