- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03099889
WHISH-2-Prevent Heart Failure
Women's Health Initiative Strong and Healthy Exercise Trial-2-Prevent Heart Failure
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Rhode Island
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Pawtucket, Rhode Island, Forente stater, 02860
- Memorial Hospital of Rhode Island
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- alive, community dwelling,
Exclusion Criteria:
- Dementia, need walking aide, reside in nursing home
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Physical activity intervention based upon stage of change and social cognitive theory based interventions
|
|
Ingen inngripen: Control arm
Receive general health mailings
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
hospitalized heart failure
Tidsramme: within 4 years of randomization
|
first acute decompensated hospitalized heart failure event
|
within 4 years of randomization
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Heart failure with reduced ejection fraction
Tidsramme: within 4 years of randomization
|
reduced systolic function on echo or other objective imaging
|
within 4 years of randomization
|
|
Heart failure with preserved ejection fraction
Tidsramme: within 4 years of randomization
|
normal systolic function on echo or other objective imaging
|
within 4 years of randomization
|
|
Recurrent hospitalized heart failure
Tidsramme: within 4 years of randomization
|
number of acute decompensated heart failure events
|
within 4 years of randomization
|
|
Cardiovascular disease mortality
Tidsramme: within 4 years of randomization
|
Underlying cause of death was either heart failure or cardiovascular disease
|
within 4 years of randomization
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Charles B Eaton, MD, MS, Memorial Hospital of Rhode Island
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 5R01HL130591-02 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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