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WHISH-2-Prevent Heart Failure

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03099889
Enrollment
49936
Registered
2017-04-04
Start date
2015-04-15
Completion date
2021-07-01
Last updated
2019-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Detailed 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.

Interventions

BEHAVIORALPhysical Activity

Physical activity intervention based upon stage of change and social cognitive theory based interventions

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

Participant in intervention arm signed an informed consent umasking the exercise intervention, participants in the control arm have already consented to ongoing outcomes assessment and yearly surveys regarding physical activity and other lifestyle activities

Intervention model description

randomized consent design

Eligibility

Sex/Gender
FEMALE
Age
66 Years to 102 Years
Healthy volunteers
Yes

Inclusion criteria

* alive, community dwelling,

Exclusion criteria

* Dementia, need walking aide, reside in nursing home

Design outcomes

Primary

MeasureTime frameDescription
hospitalized heart failurewithin 4 years of randomizationfirst acute decompensated hospitalized heart failure event

Secondary

MeasureTime frameDescription
Heart failure with reduced ejection fractionwithin 4 years of randomizationreduced systolic function on echo or other objective imaging
Heart failure with preserved ejection fractionwithin 4 years of randomizationnormal systolic function on echo or other objective imaging
Recurrent hospitalized heart failurewithin 4 years of randomizationnumber of acute decompensated heart failure events
Cardiovascular disease mortalitywithin 4 years of randomizationUnderlying cause of death was either heart failure or cardiovascular disease

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026