- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03099889
WHISH-2-Prevent Heart Failure
Women's Health Initiative Strong and Healthy Exercise Trial-2-Prevent Heart Failure
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Rhode Island
-
Pawtucket, Rhode Island, Förenta staterna, 02860
- Memorial Hospital of Rhode Island
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- alive, community dwelling,
Exclusion Criteria:
- Dementia, need walking aide, reside in nursing home
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Inget ingripande: Control arm
Receive general health mailings
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
hospitalized heart failure
Tidsram: within 4 years of randomization
|
first acute decompensated hospitalized heart failure event
|
within 4 years of randomization
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Heart failure with reduced ejection fraction
Tidsram: 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
Tidsram: within 4 years of randomization
|
normal systolic function on echo or other objective imaging
|
within 4 years of randomization
|
|
Recurrent hospitalized heart failure
Tidsram: within 4 years of randomization
|
number of acute decompensated heart failure events
|
within 4 years of randomization
|
|
Cardiovascular disease mortality
Tidsram: within 4 years of randomization
|
Underlying cause of death was either heart failure or cardiovascular disease
|
within 4 years of randomization
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Charles B Eaton, MD, MS, Memorial Hospital of Rhode Island
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 5R01HL130591-02 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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