Physical ActivityNCT03099889
WHISH-2-Prevent Heart Failure
A study testing Physical Activity in people with Physical Activity and Heart Failure, run by Memorial Hospital of Rhode Island at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 66 to 102 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Heart Failure, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49,936 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2015to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 to 102 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- alive, community dwelling,
Who cannot join
- Dementia, need walking aide, reside in nursing home
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity, Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Normal Ejection Fraction, Strength Training, Elderly
- Being tested
- Physical Activity
- Medical subject headings
- Motor Activity, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Physical activity intervention based upon stage of change and social cognitive theory based interventions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physical Activity |
| Control arm | No intervention | Receive general health mailings |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospitalized heart failure
first acute decompensated hospitalized heart failure event
Measured: within 4 years of randomization
Secondary outcomes (4)
Heart failure with reduced ejection fraction
reduced systolic function on echo or other objective imaging
Measured: within 4 years of randomization
Heart failure with preserved ejection fraction
normal systolic function on echo or other objective imaging
Measured: within 4 years of randomization
Recurrent hospitalized heart failure
number of acute decompensated heart failure events
Measured: within 4 years of randomization
Cardiovascular disease mortality
Underlying cause of death was either heart failure or cardiovascular disease
Measured: within 4 years of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start15 Apr 2015
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized consent design
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 49,936 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Charles B. Eaton, Memorial Hospital of Rhode Island
- Investigators
- Charles B Eaton, MD, MS, Principal investigator, Memorial Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099889
- Sponsor's protocol ID
- 5R01HL130591-02
- Status last verified
- May 2019
- First submitted
- 22 Mar 2017
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Health Initiative Strong and Healthy Exercise Trial-2-Prevent Heart Failure
- ClinicalTrials.gov ID
- NCT03099889
- Acronym / sponsor ID
- 5R01HL130591-02
- Conditions
- Physical Activity, Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Normal Ejection Fraction, Strength Training, Elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49,936 participants (actual)
- Lead sponsor
- Memorial Hospital of Rhode IslandUniversity, hospital or other
- 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
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized consent design
| Arm | Type | Receives |
|---|---|---|
| Physical Activity intervention arm | Experimental | Behavioral: Physical ActivityReceive 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. |
| Control arm | No intervention | –Receive general health mailings |
Who may qualify
- Ages
- 66 to 102 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- alive, community dwelling,
Key exclusion criteria (1 listed)
- Dementia, need walking aide, reside in nursing home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityPhysical activity intervention based upon stage of change and social cognitive theory based interventions | Behavioural | Physical Activity intervention arm |
Primary outcome
hospitalized heart failure
Time frame: within 4 years of randomization
first acute decompensated hospitalized heart failure event
4 secondary outcomes
Heart failure with reduced ejection fraction
Time frame: within 4 years of randomization
Heart failure with preserved ejection fraction
Time frame: within 4 years of randomization
Recurrent hospitalized heart failure
Time frame: within 4 years of randomization
Cardiovascular disease mortality
Time frame: within 4 years of randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles B Eaton, MD, MS principal investigator
Memorial Hospital of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Physical Activity and Heart Failure, run by Memorial Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospitalized heart failure (time frame: within 4 years of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019; AzTrials last refreshed its copy on 28 Oct 2026.