NCT03099889

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
49,936

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

5.4 years

First QC Date

March 22, 2017

Last Update Submit

May 3, 2019

Conditions

Physical ActivityHeart FailureHeart Failure With Reduced Ejection FractionHeart Failure With Normal Ejection FractionStrength TrainingElderlyWomen

Outcome Measures

Primary Outcomes (1)

  • hospitalized heart failure

    first acute decompensated hospitalized heart failure event

    within 4 years of randomization

Secondary Outcomes (4)

  • Heart failure with reduced ejection fraction

    within 4 years of randomization

  • Heart failure with preserved ejection fraction

    within 4 years of randomization

  • Recurrent hospitalized heart failure

    within 4 years of randomization

  • Cardiovascular disease mortality

    within 4 years of randomization

Study Arms (2)

Physical Activity intervention arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

Receive general health mailings

Interventions

Physical ActivityBEHAVIORAL

Physical activity intervention based upon stage of change and social cognitive theory based interventions

Physical Activity intervention arm

Eligibility Criteria

Age66 Years - 102 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsself-identified as post-menopausal women and participate in the women's health initiative study
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • alive, community dwelling,

You may not qualify if:

  • Dementia, need walking aide, reside in nursing home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

MeSH Terms

Conditions

Motor ActivityHeart Failure

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Charles B Eaton, MD, MS

    Memorial Hospital of Rhode Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized consent design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2017

First Posted

April 4, 2017

Study Start

April 15, 2015

Primary Completion

September 1, 2020

Study Completion

July 1, 2021

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

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

Locations

US(1)