WHISH-2-Prevent Heart Failure

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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Physical Activity; Elderly; Heart Failure With Reduced Ejection Fraction; Heart Failure With Normal Ejection Fraction; Women; Strength Training
• Intervention / Treatment: Behavioral: Physical Activity

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.

• Study Type: Interventional
• Enrollment (Actual): 49936
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • Memorial Hospital of Rhode Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 66 years to 102 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• alive, community dwelling,

Exclusion Criteria:

• Dementia, need walking aide, reside in nursing home

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Hospital of Rhode Island
• Collaborators: University of California, San Diego; National Heart, Lung, and Blood Institute (NHLBI); University of California, San Francisco; Fred Hutchinson Cancer Center; Stanford University; Ohio State University; University at Buffalo; University of North Carolina, Chapel Hill; Wake Forest University
• Investigators: Principal Investigator: Charles B Eaton, MD, MS, Memorial Hospital of Rhode Island

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2015
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 5R01HL130591-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Within two years of completion of study, de-identified data will be made available via WHI website after approval by the Publications and Presentation committee and data use agreement signed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No