50 Participants NeededMy employer runs this trial

Invasive Hemodynamic for Congenital Heart Disease

AR
Alexander Egbe, MBBS, MPH profile photo
Overseen ByAlexander Egbe, MBBS, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather data on adult congenital heart disease using invasive hemodynamic monitoring. This method helps researchers understand blood flow and provides important insights into heart conditions. The trial seeks participants who can consent, have a healthy weight (BMI of 30 or lower), normal blood pressure, and good kidney function. Participants should not have a history of heart disease, current orthopedic issues, or be taking heart medications. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in heart health.

Will I have to stop taking my current medications?

If you are currently taking any heart-related medications, you cannot participate in this trial.

What prior data suggests that this invasive hemodynamic method is safe for congenital heart disease?

Research has shown that invasive heart monitoring is generally well-tolerated by patients, including those with complex congenital heart conditions. One study found that most patients did not experience major problems during this type of monitoring. Another study examined the CardioMEMS™ HF System, a specific device for monitoring heart function, and found it safe for tracking heart issues. However, adults with certain heart conditions, such as Fontan circulation, may experience higher rates of hospital visits and heart failure. This does not imply that the monitoring is unsafe, but it underscores the need for careful medical supervision. Overall, while invasive heart monitoring involves placing devices to closely observe the heart, current evidence suggests it is safe for most patients.12345

Why are researchers excited about this trial?

Researchers are excited about invasive hemodynamic techniques for managing heart conditions because these methods provide real-time, precise measurements of heart function. Unlike standard non-invasive methods, which often rely on indirect indicators, invasive hemodynamic monitoring gives direct insights into pressures within the heart chambers and major blood vessels. This detailed information can lead to more accurate diagnoses and tailored treatments, potentially improving outcomes for patients with complex heart conditions.

What evidence suggests that invasive hemodynamic is effective for congenital heart disease?

Research has shown that advanced techniques for monitoring blood flow and pressure inside the heart can greatly improve care for people with congenital heart disease (CHD). New treatments have extended the lives of these patients. This monitoring reduces the need for more invasive procedures, such as certain heart tests, especially for those with complex heart issues. It provides doctors with crucial information to better manage and treat heart problems. Overall, these advanced monitoring methods hold promise for improving CHD treatment by delivering more accurate and timely information.15678

Who Is on the Research Team?

AE

Alexander Egbe, MBBS, MPH

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

Capacity to Consent
BMI </= 30
Systolic BP </= 140mmHg
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Participants undergo invasive hemodynamic assessments to provide comparative data for the registry

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Invasive Hemodynamic

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Critical Care of the Adult With Congenital Heart Disease - PMC

Advances in the treatment of congenital heart disease (CHD) have led to dramatic improvements in survival for individuals with CHD.

Characteristics and Outcomes of Adults With Congenital ...

ACHD admissions were more commonly for heart failure (21.3% vs 15.7%, P < 0.001), general medical problems (15.6% vs 6.0%, P < 0.001), and atrial arrhythmias ( ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38761965/

Invasive Implanted Hemodynamic Monitoring in Patients ...

IHM has the potential to reduce the number of cardiac catheterizations in anatomically complex patients and, in patients with Fontan circulation ...

Continuous Data-Driven Monitoring in Critical Congenital ...

Analyzing continuous physiologic data to find hemodynamic signatures associated with new brain injury after congenital heart surgery. Crit Care ...

A Study of Hemodynamic Cardiopulmonary Exercise for CHD

The purpose of this study is to compare the difference in the ability to detect hemodynamic abnormalities between invasive hemodynamic assessments performed at ...

Expanding the Use of Invasive Implanted Hemodynamic ...

What is the safety and utility of invasive implanted hemodynamic monitoring (IHM) using the CardioMEMS™ HF System (Abbott Laboratories, Abbott ...

Modeling Major Adverse Outcomes of Pediatric and Adult ...

The goal of this project was to develop a risk-standardization methodology to adjust for patient characteristics when comparing major adverse outcomes.

Critical Care of the Adult With Congenital Heart Disease

Adults with Fontan circulation have a higher incidence of hospitalization and death due to heart failure compared to adults with other CHD as ...