WHISH-2-Prevent Heart Failure

Heart Failure Clinical Trial

Official title:

Women's Health Initiative Strong and Healthy Exercise Trial-2-Prevent Heart Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03099889
• Other study ID #: 5R01HL130591-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 15, 2015
• Est. completion date: July 1, 2021

Study information

• Verified date: May 2019
• Source: Memorial Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The WHISH-2-Prevent Heart Failure (HF) study is an ancillary study to the Women's Health Initiative Strong and Healthy (WHISH) exercise pragmatic trial. The WHISH-2-Prevent HF trial examines the intervention effect of physical activity (PA) on both incident HF and HF burden (recurrent HF and CVD death in those with HF) in a cost effective manner in elderly women. In addition, it will allow a dose-finding analysis to better understand the type, intensity and frequency of PA that leads to a reduced risk and burden of HF. The focus of the parent WHISH trial is on atherosclerotic cardiovascular disease and not heart failure.

Description:

A recently funded large pragmatic PA trial, Women's Health Initiative Strong and Healthy (WHISH) trial based upon two decades of PA intervention experience using enhanced communication and behavioral techniques, has randomized 49,936 elderly women (average age 79) and will evaluate its intervention effect on the risk of atherosclerotic CVD. This translational intervention is aimed at reducing sedentary time and achieving or maintaining aerobic and strength enhancing PA levels currently recommended for cardiovascular benefit. The WHISH-2-Prevent HF, represents the first and largest primary prevention exercise trial ever performed focusing on HF and will examine the intervention effect of PA , on both incident HF and HF burden (recurrent HF and CVD death in those with HF) in a cost effective manner in elderly women. In addition, it will allow a dose-finding analysis to better understand the type, intensity and frequency of PA that leads to a reduced risk and burden of HF.

Aim 1: Test whether older women who are initially free of HF and randomized to a translational PA intervention will reduce the rate of incident HF compared to those not randomized to the translational PA intervention.

H1: Women free of HF randomized to the PA intervention will have reduced rates of incident HF compared to those not randomized.

Aim 2: Test whether older women with and without HF at baseline randomized to a translational PA intervention will reduce the HF burden (number of acute HF hospitalizations and CVD death in those with antecedent HF) compared to those not randomized to the translational PA intervention. H2: Women randomized to the PA intervention will have reduced HF Burden compared to those not randomized

Exploratory Aim 3: Analyze the type, intensity and frequency of physical activity including skeletal muscle strengthening associated with a reduced risk of HF and HF burden in elderly women. H3: Women who have low levels of sedentary behavior by either increasing or maintaining light intensity or moderate intensity physical activity will have reduced rates of HF compared to women who remain sedentary. Those that add skeletal muscle strengthening will have additional benefits.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49936
• Est. completion date: July 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 66 Years to 102 Years

Eligibility

Inclusion Criteria:

• alive, community dwelling,

Exclusion Criteria:

• Dementia, need walking aide, reside in nursing home

Related Conditions & MeSH terms

• Elderly
• Heart Failure
• Heart Failure With Normal Ejection Fraction
• Heart Failure With Reduced Ejection Fraction
• Physical Activity
• Strength Training
• Women

Intervention

Behavioral:
• Physical Activity
Physical activity intervention based upon stage of change and social cognitive theory based interventions

Locations

Country	Name	City	State
United States	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island

Sponsors (10)

Lead Sponsor	Collaborator
Memorial Hospital of Rhode Island	Fred Hutchinson Cancer Research Center, National Heart, Lung, and Blood Institute (NHLBI), Ohio State University, Stanford University, University at Buffalo, University of California, San Diego, University of California, San Francisco, University of North Carolina, Chapel Hill, Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospitalized heart failure	first acute decompensated hospitalized heart failure event	within 4 years of randomization
Secondary	Heart failure with reduced ejection fraction	reduced systolic function on echo or other objective imaging	within 4 years of randomization
Secondary	Heart failure with preserved ejection fraction	normal systolic function on echo or other objective imaging	within 4 years of randomization
Secondary	Recurrent hospitalized heart failure	number of acute decompensated heart failure events	within 4 years of randomization
Secondary	Cardiovascular disease mortality	Underlying cause of death was either heart failure or cardiovascular disease	within 4 years of randomization