NCT02275819

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

Completed NA Results posted Last updated 8 March 2021

What this trial tests

NA trial testing Exercise in Heart Failure in 11 participants. Completed in 23 April 2019.

Timeline

6 June 2016

Primary endpoint
23 April 2019

23 April 2019

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	6 June 2016
Primary completion	23 April 2019
Estimated completion	23 April 2019
Sites	1 location across United States

Drugs / interventions tested

• Exercise

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

50 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Left Ventricular Systolic Function. Primary · Baseline and endpoint at 3-5 months

Change in left ventricular ejection fraction.

Group	Value	95% CI
Control	.82	± 3.54
Intervention Group	-1.90	± 1.14

Change in Left Ventricular Structure. Primary · Baseline and endpoint at 3-5 months

Change in left ventricular mass.

Group	Value	95% CI
Control	-34.8	± 49.8
Intervention Group	3.1	± 40.8

Change in Diastolic Function. Primary · Baseline and endpoint at 3-5 months

Change in mitral annular early diastolic velocity (e')

Group	Value	95% CI
Control	.31	± .68
Intervention Group	-1.07	± 1.42

Change in Left Ventricular (LV) Diastolic Function Primary · Baseline and endpoint at 3-5 months

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

Group	Value	95% CI
Control	-1.85	± 3.06
Intervention Group	2.68	± 3.49

Change in Right Ventricular Function Primary · Baseline and endpoint at 3-5 months

Change in tricuspid annular tissue doppler velocity

Group	Value	95% CI
Control	0.16	± 1.04
Intervention Group	-0.70	± 2.05

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected while participants were enrolled from enrollment until collection of the final study endpoint at 3-5 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control

Serious: 0/5 (0%)

Deaths: 0/5

Intervention Group

Serious: 4/5 (80%)

Deaths: 0/5

Serious adverse events (4 terms)

Reaction	System	Control	Intervention Group
ER Visit	Respiratory, thoracic and mediastinal disorders	—	—
HF exacerbation	Cardiac disorders	—	—
Low BP	Cardiac disorders	—	—
A-fib Hospitalization	Cardiac disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Control	Intervention Group
Not Fasted	General disorders	—	—

Most-reported serious reactions: ER Visit, HF exacerbation, Low BP, A-fib Hospitalization.

Data from ClinicalTrials.gov NCT02275819 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.