WHISH-2-Prevent Heart Failure
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|ClinicalTrials.gov Identifier: NCT03099889|
Recruitment Status : Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Physical Activity Heart Failure Heart Failure With Reduced Ejection Fraction Heart Failure With Normal Ejection Fraction Strength Training Elderly Women||Behavioral: Physical Activity||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49936 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized consent design|
|Masking:||Triple (Care Provider, 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|
|Official Title:||Women's Health Initiative Strong and Healthy Exercise Trial-2-Prevent Heart Failure|
|Actual Study Start Date :||April 15, 2015|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||July 1, 2021|
Experimental: Physical Activity intervention arm
Receive a tailored behavioral interventions for exercise and strength training via multiple channels including frequent mailings, integrated voice response and outreach phone calls, interactive website, and referral to local community exercise resources.
Behavioral: Physical Activity
Physical activity intervention based upon stage of change and social cognitive theory based interventions
No Intervention: Control arm
Receive general health mailings
- hospitalized heart failure [ Time Frame: within 4 years of randomization ]first acute decompensated hospitalized heart failure event
- Heart failure with reduced ejection fraction [ Time Frame: within 4 years of randomization ]reduced systolic function on echo or other objective imaging
- Heart failure with preserved ejection fraction [ Time Frame: within 4 years of randomization ]normal systolic function on echo or other objective imaging
- Recurrent hospitalized heart failure [ Time Frame: within 4 years of randomization ]number of acute decompensated heart failure events
- Cardiovascular disease mortality [ Time Frame: within 4 years of randomization ]Underlying cause of death was either heart failure or cardiovascular disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099889
|United States, Rhode Island|
|Memorial Hospital of Rhode Island|
|Pawtucket, Rhode Island, United States, 02860|
|Principal Investigator:||Charles B Eaton, MD, MS||Memorial Hospital of Rhode Island|