Monitoring pregnant women with congenital heart disease using wrist wearables
Single Center Pilot Study of Remote Monitoring in Pregnant Women With Congenital Heart Disease Using Wrist Wearables
This study is testing whether using wrist wearables to monitor the health of pregnant women with congenital heart disease can help track their condition and improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06818760 on ClinicalTrials.gov |
What this trial studies
This study focuses on pregnant women with congenital heart disease (CHD) and aims to utilize continuous physiologic data obtained from wearable biosensors to improve biomarkers of disease progression and prognosis. By monitoring these patients at home, the study seeks to enhance understanding of their health status and experiences with wearable technology. The research is particularly relevant given the rising maternal cardiovascular disease rates and the need for better monitoring to prevent serious complications. The study will involve women evaluated in a cardio-obstetrics clinic, ensuring a targeted approach to this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with congenital heart disease classified as mWHO Class II or higher.
Not a fit: Patients with mild congenital heart conditions classified as mWHO Class I are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and outcomes for pregnant women with congenital heart disease.
How similar studies have performed: While there have been advances in maternal cardiovascular disease monitoring, this specific approach using wearable technology is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Women evaluated in the cardio-obstetrics clinic either prepartum, intrapartum, or postpartum with congenital heart disease. * Congenital heart disease: Based on modified World Health Organization (mWHO) classification of maternal cardiovascular disease group ≥ II. * mWHO Class I include mild pulmonary stenosis, uncomplicated patent ductus arteriosus, and repaired shunts, to be excluded. * mWHO Class II includes unoperated atrial septal defect or ventricular septal defect and repaired tetralogy of Fallot. * mWHO Class II-III includes mild left ventricular impairment, valvular heart disease not in class I, repaired aortic coarctation, Marfan without aortic dilation, bicuspid aortic valve with \<45 mm root, hypertrophic cardiomyopathy. * mWHO Class III includes systemic right ventricle, Fontan circulation, unrepaired cyanotic heart disease, Marfan with aorta 40-45 mm, bicuspid aortic valve with root 45-50 mm, other complex congenital heart disease (such as Shone complex). * mWHO Class IV includes Marfan with \>45 mm aorta, bicuspid aortic valve with \> 50 mm aorta, severe systemic ventricular dysfunction (EF\<30%), severe symptomatic AS or MS, native severe coarctation, all severe pulmonary hypertension patients from any cause. * Congenital valvular heart disease: * Native valvular heart disease: tricuspid, pulmonary, mitral and aortic with ≥ moderate regurgitation or stenosis by echocardiography. * Bioprosthetic valvular heart disease with ≥ moderate regurgitation or stenosis by echocardiography. * Any mechanical valve prosthesis * Congenital Cardiomyopathy * Cardiomyopathy with EF \< 30% * Cardiomyopathy with EF 30-50% * Provide Informed consent * Age \> 18 years of age Exclusion Criteria: * Patients on hemodialysis
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Joanna Ghobrial, MD — The Cleveland Clinic
- Study coordinator: Joanna Ghobrial, MD
- Email: GHOBRIJ@ccf.org
- Phone: 216-444-5923
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.