Women's Health Initiative Silent Atrial Fibrillation Recording Study

Atrial Fibrillation Clinical Trial

— WHISH STAR  

Official title:

Women's Health Initiative Strong and Healthy Silent Atrial Fibrillation Recording Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05366803
• Other study ID #: 40082
• Status: Completed
• Phase: N/A
• Start date: September 8, 2017
• Est. completion date: February 11, 2020

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the WHISH STAR study is to investigate whether or not those who are randomized to exercise intervention have higher rates of atrial fibrillation on review of medical records and, in a subset, on screening with a cardiac ECG patch monitor. We will also study whether those with a known history of AF have any changes in AF hospitalizations due to exercise.

Description:

The Silent Atrial Fibrillation Recording study (STAR) study is an ancillary study of the NIH-funded Women's Health Initiative Strong and Healthy (WHISH). The purpose of the Women's Health Initiative Strong and Healthy study (WHISH) is to investigate if light to moderate exercise decreases incident atrial fibrillation (AF) among women over 65 who have no baseline AF. The purpose of the STAR study is to investigate the effect of exercise intervention on incident atrial fibrillation ascertained with diagnostic codes. In a subset of women, subclinical atrial fibrillation will be ascertained with cardiac patch ECG monitoring technology (iRhythm's ZIO® XT Patch). This subgroup of WHISH study participants will undergo an 8 day cardiac patch recording at baseline, six (6) months, and one (1) year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1257
• Est. completion date: February 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years to 100 Years

Eligibility

Inclusion Criteria:

• Subjects already enrolled in the parent WHISH study.

• Subjects who are at high risk of developing atrial fibrillation.

Exclusion Criteria:

• Subjects who have had atrial fibrillation at baseline.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Behavioral:
• Physical Activity
The PA intervention will consist of a multimodal activity program of aerobics, balance, strength, flexibility. The intervention will involve encouraging participants to increase all forms of PA throughout the day and to decrease sedentary time, such as sitting. This may include activities such as leisure sports, gardening, use of stairs instead of escalators, leisurely walks with friends, and less use of remote control devices.The intervention is conducted primarily by mail with website support and resources available.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Incidence of Atrial Fibrillation Due to Exercise		One year
Primary	Number of Participants without Clinically Diagnosed Atrial Fibrillation (AF) Found to have Silent AF with Prolonged ECG Patch Monitoring		One year