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WHISH-2-Prevent Heart Failure

Primary Purpose

Physical Activity, Heart Failure, Heart Failure With Reduced Ejection Fraction

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
Memorial Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Activity

Eligibility Criteria

66 Years - 102 Years (Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • alive, community dwelling,

Exclusion Criteria:

  • Dementia, need walking aide, reside in nursing home

Sites / Locations

  • Memorial Hospital of Rhode Island

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical Activity intervention arm

Control arm

Arm Description

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.

Receive general health mailings

Outcomes

Primary Outcome Measures

hospitalized heart failure
first acute decompensated hospitalized heart failure event

Secondary Outcome Measures

Heart failure with reduced ejection fraction
reduced systolic function on echo or other objective imaging
Heart failure with preserved ejection fraction
normal systolic function on echo or other objective imaging
Recurrent hospitalized heart failure
number of acute decompensated heart failure events
Cardiovascular disease mortality
Underlying cause of death was either heart failure or cardiovascular disease

Full Information

First Posted
March 22, 2017
Last Updated
May 3, 2019
Sponsor
Memorial Hospital of Rhode Island
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Stanford University, Ohio State University, Fred Hutchinson Cancer Center, University of North Carolina, Chapel Hill, University of California, San Francisco, University of California, San Diego, University at Buffalo, Wake Forest University
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1. Study Identification

Unique Protocol Identification Number
NCT03099889
Brief Title
WHISH-2-Prevent Heart Failure
Official Title
Women's Health Initiative Strong and Healthy Exercise Trial-2-Prevent Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2015 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial Hospital of Rhode Island
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Stanford University, Ohio State University, Fred Hutchinson Cancer Center, University of North Carolina, Chapel Hill, University of California, San Francisco, University of California, San Diego, University at Buffalo, Wake Forest University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Normal Ejection Fraction, Strength Training, Elderly, Women

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized consent design
Masking
Care ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
49936 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Receive general health mailings
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
Physical activity intervention based upon stage of change and social cognitive theory based interventions
Primary Outcome Measure Information:
Title
hospitalized heart failure
Description
first acute decompensated hospitalized heart failure event
Time Frame
within 4 years of randomization
Secondary Outcome Measure Information:
Title
Heart failure with reduced ejection fraction
Description
reduced systolic function on echo or other objective imaging
Time Frame
within 4 years of randomization
Title
Heart failure with preserved ejection fraction
Description
normal systolic function on echo or other objective imaging
Time Frame
within 4 years of randomization
Title
Recurrent hospitalized heart failure
Description
number of acute decompensated heart failure events
Time Frame
within 4 years of randomization
Title
Cardiovascular disease mortality
Description
Underlying cause of death was either heart failure or cardiovascular disease
Time Frame
within 4 years of randomization

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
self-identified as post-menopausal women and participate in the women's health initiative study
Minimum Age & Unit of Time
66 Years
Maximum Age & Unit of Time
102 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: alive, community dwelling, Exclusion Criteria: Dementia, need walking aide, reside in nursing home
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles B Eaton, MD, MS
Organizational Affiliation
Memorial Hospital of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hospital of Rhode Island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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WHISH-2-Prevent Heart Failure

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