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Trial record 6 of 41 for:    women's health initiative

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 : April 4, 2017
Sponsor:
Collaborators:
Stanford University
Ohio State University
Fred Hutchinson Cancer Research Center
University of North Carolina, Chapel Hill
University of California, San Francisco
University of California, San Diego
University at Buffalo
Information provided by (Responsible Party):
Charles B. Eaton, Memorial Hospital of Rhode Island

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.

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

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  (Clinical Trial)
Actual Enrollment : 49936 participants
Allocation: Randomized
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
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. hospitalized heart failure [ Time Frame: within 4 years of randomization ]
    first acute decompensated hospitalized heart failure event


Secondary Outcome Measures :
  1. Heart failure with reduced ejection fraction [ Time Frame: within 4 years of randomization ]
    reduced systolic function on echo or other objective imaging

  2. Heart failure with preserved ejection fraction [ Time Frame: within 4 years of randomization ]
    normal systolic function on echo or other objective imaging

  3. Recurrent hospitalized heart failure [ Time Frame: within 4 years of randomization ]
    number of acute decompensated heart failure events

  4. Cardiovascular disease mortality [ Time Frame: within 4 years of randomization ]
    Underlying cause of death was either heart failure or cardiovascular disease



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Ages Eligible for Study:   66 Years to 102 Years   (Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-identified as post-menopausal women and participate in the women's health initiative study
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • alive, community dwelling,

Exclusion Criteria:

  • Dementia, need walking aide, reside in nursing home

Information from the National Library of Medicine

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


Locations
United States, Rhode Island
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States, 02860
Sponsors and Collaborators
Memorial Hospital of Rhode Island
Stanford University
Ohio State University
Fred Hutchinson Cancer Research Center
University of North Carolina, Chapel Hill
University of California, San Francisco
University of California, San Diego
University at Buffalo
Investigators
Principal Investigator: Charles B Eaton, MD, MS Memorial Hospital of Rhode Island

Responsible Party: Charles B. Eaton, Principal Investigator, Memorial Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT03099889     History of Changes
Other Study ID Numbers: 5R01HL130591-02 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases