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

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Exercise, Echocardiography

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control

Intervention group

Arm Description

Will not receive intervention with exercise

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

Outcomes

Primary Outcome Measures

Change in Left Ventricular Systolic Function.

Change in left ventricular ejection fraction.

Change in Left Ventricular Structure.

Change in left ventricular mass.

Change in Diastolic Function.

Change in mitral annular early diastolic velocity (e')

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')

Change in Right Ventricular Function

Change in tricuspid annular tissue doppler velocity

Secondary Outcome Measures

Full Information

NCT ID

NCT02275819

First Posted

October 3, 2014

Last Updated

March 4, 2021

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT02275819

Brief Title

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

Official Title

Exercise Training in Heart Failure: Structural and Functional Cardiac Remodeling

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

June 6, 2016 (Actual)

Primary Completion Date

April 23, 2019 (Actual)

Study Completion Date

April 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Prevalence of systolic heart failure (HF) is high among the growing population of older adults. Progressive cardiac remodeling and deteriorating cardiac output have been implicated as key factors underlying HF-related exercise intolerance and quality of life. Even after implementing medical and device therapies that moderate remodeling, exercise tolerance remains impaired. While exercise training has been demonstrated to improve exercise capacity, mechanisms facilitating this benefit remain unclear. Peripheral adaptations in the skeletal muscle and vasculature provide at least some benefit, however reverse cardiac remodeling (beyond effects of pharmacological and device therapies) may be additive. The investigators propose to study the impact of 2 different types of exercise on cardiac morphology as well as systolic and diastolic performance and related functional gains. The investigators will compare traditional aerobic training to a novel regimen of inspiratory muscle training (IMT). IMT is a specific type of exercise training that may be particularly useful for frail, infirmed HF patients who are unlikely to tolerate aerobic training. Effects of IMT on remodeling have not been previously studied. The proposed echocardiography pilot study builds on a funded VA Merit F0834-R "Exercise Therapy to Reduce Heart Failure Symptoms; Sorting Mechanisms of Benefit" (Exercise therapy) PI, Forman that compares different modes of exercise training in older (age 50yrs) systolic (EF 45%) HF patients. The original study assesses peripheral mechanisms affected by exercise training, but was not designed to assess cardiac remodeling. The proposed pilot study provides a vital complementary analysis, i.e., it adds assessments of cardiac remodeling as well as related changes in systolic and diastolic performance.

6. Conditions and Keywords

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

Heart Failure

Keywords

Heart Failure, Exercise, Echocardiography

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

No Intervention

Arm Description

Will not receive intervention with exercise

Arm Title

Intervention group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

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)

Primary Outcome Measure Information:

Title

Change in Left Ventricular Systolic Function.

Description

Change in left ventricular ejection fraction.

Time Frame