WHISH-2-Prevent Heart Failure

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Physical Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: alive, community dwelling, Exclusion Criteria: Dementia, need walking aide, reside in nursing home

Ages Eligible for Study
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Minimum Age: 66 Years
Maximum Age: 102 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized consent design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Activity intervention arm<br>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<br>* Physical activity intervention based upon stage of change and social cognitive theory based interventions<br>|
| No Intervention: Control arm<br>Receive general health mailings | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospitalized heart failure | first acute decompensated hospitalized heart failure event | within 4 years of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure with reduced ejection fraction | reduced systolic function on echo or other objective imaging | within 4 years of randomization | 
| Heart failure with preserved ejection fraction | normal systolic function on echo or other objective imaging | within 4 years of randomization | 
| Recurrent hospitalized heart failure | number of acute decompensated heart failure events | within 4 years of randomization | 
| Cardiovascular disease mortality | Underlying cause of death was either heart failure or cardiovascular disease | within 4 years of randomization |