Exercise Training in Heart Failure: Changes in Cardiac Structure and Function

NCT02275819 | Completed Results

• 1 other identifier: E1423-P
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study being conducted to better understand the impact of exercise training on changes on the structure and function of the heart. Exercise training in patients with heart failure has been shown to be beneficial at decreasing symptoms of heart failure and improving overall functional capacity or capacity to exercise. However the mechanisms responsible for this are still unclear. This study will look specifically at how exercise creates changes within the hearts filling ability, the hearts pumping strength as well as the hearts ability to rebuild.

Conditions

Heart Failure

Keywords

Heart Failure; Exercise; Echocardiography

Outcome Measures

Primary Outcomes (5)

• Change in Left Ventricular Systolic Function.

  Change in left ventricular ejection fraction.

  Baseline and endpoint at 3-5 months

• Change in Left Ventricular Structure.

  Change in left ventricular mass.

  Baseline and endpoint at 3-5 months

• Change in Diastolic Function.

  Change in mitral annular early diastolic velocity (e')

  Baseline and endpoint at 3-5 months

• Change in Left Ventricular (LV) Diastolic Function

  Change in the ratio of early mitral in-flow velocity (E) to mitral annular early diastolic velocity (e')

  Baseline and endpoint at 3-5 months

• Change in Right Ventricular Function

  Change in tricuspid annular tissue doppler velocity

  Baseline and endpoint at 3-5 months

Study Arms (2)

control

NO INTERVENTION

Will not receive intervention with exercise

Intervention group

ACTIVE COMPARATOR

2 groups will receive 2 different types of therapy (exercise or Inspiratory Muscle Therapy)

Other: Exercise

Interventions

Exercise OTHER

Exercise (walking 3 times a week for 60 minutes) or Inspiratory Muscle Therapy (breathing against an inspiratory resistive load 3 times a week for up to 60 minutes)

Intervention group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New York Heart Association (NYHA) class II or III for the previous three months despite a minimum of 6 weeks of optimal treatment.
• Age \>50 years.
• Left Ventricular Ejection Fraction (LVEF)\<45% (by echocardiogram or radionucleotide imaging study within 6 months of enrollment). If a patient has initiated or received any therapy that might improve the ejection fraction, the qualifying EF must be assessed after the patient is on a stable dose of these therapies. Additionally the LVEF of \<45% will be confirmed with a brief echocardiogram prior to randomization. If LVEF is not 45%, the patient will not be enrolled in to the study.
• Optimal therapy according to the American Heart Association (AHA)/American College of Cardiology (ACC) and the Heart Failure Society of America (HFSA) Heart Failure (HF) guidelines, including treatment with an angiotensin-converting-enzyme (ACE) Inhibitor (or an angiotensin receptor blocker) and beta-blocker therapy (for at least 6 weeks), or have documented reason for variation, including medication intolerance, contraindication, patient preference, or personal physician's judgment.
• In addition to the above we have now added patients with heart failure with preserved ejection fraction (similar to the parent study )pending Institutional Review Board (IRB) review.

You may not qualify if:

• Major cardiovascular event or procedure within the prior 6 weeks.
• Dementia.
• Severe chronic obstructive pulmonary disease (COPD) (FEV1\<50%), peripheral vascular disease (PVD), and/or Anemia.
• End-stage malignancy.
• Severe valvular heart disease.
• Orthopedic exercise limitation.
• Women who are pregnant, breastfeeding, or likely to become pregnant within the next 6 months.
• Psychiatric hospitalization within the last 3 months.
• Implantable Cardioverter Defibrillator (ICD) device with heart rate limits that prohibit exercise assessments or exercise training. Referring physicians will be provided with an opportunity to reprogram devices so that patients can participate.
• Chronic ethyl alcohol (ETOH) or drug dependency.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Participation in this study hinged on recruitment into the parent study which was delayed due to various location and staff changes and early termination.

Results Point of Contact

• Title: Dr. Jayashri Aragam
• Organization: VA Boston Healthcare System

Jayashri.Aragam@va.gov

617-323-7700

Study Officials

• Jayashri Aragam, MD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Non-randomized case control study with two groups. One group received exercise and the controls did not.

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 27, 2014
• Study Start: June 6, 2016
• Primary Completion: April 23, 2019
• Study Completion: April 23, 2019
• Last Updated: March 8, 2021
• Results First Posted: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)