Clinical trial for Pulmonary Artery Hypertension
Official title Right Ventricular Pacing in Pulmonary Arterial Hypertension
ClinicalTrials.gov ID: NCT04194632
What this study is testing
- What it's testing
- In pulmonary arterial hypertension (PAH), progressive pulmonary vascular remodeling leads to supraphysiologic right ventricular (RV) afterload. Pharmacologic trials have shown that aggressive upfront treatment reversing pulmonary vascular remodeling successfully increases RV function and improves survival.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients referred for a clinically indicated right heart catheterization to either diagnose pulmonary arterial hypertension prior to initiating...
- Patients with pulmonary arterial hypertension with or without significant right ventricular dysfunction as assessed by baseline echocardiography and...
- Functional class 2 or 3 symptoms
- Are able to undergo cardiac MRI, endocardial mapping, and pressure volume measurements
- English speaking
You likely can't join if
- Preexisting left bundle branch block, current atrial fibrillation, or pacemaker/ defibrillators
- Functional class 4 symptoms
- Patients treated with parenteral or subcutaneous therapies for pulmonary hypertension
- Contraindication to right heart catheterization including significant thrombocytopenia (platelets \ 1.8), or pregnancy as determined by routine...
- Mean pulmonary artery pressure less than 25 mmHg as determined by the right heart catheterization on the day of the study procedure
- Pulmonary capillary wedge pressure greater than or equal to 15 mmHg as determined by the right heart catheterization on the day of the study procedure
See the full eligibility criteria
- Patients referred for a clinically indicated right heart catheterization to either diagnose pulmonary arterial hypertension prior to initiating therapies or monitor response to ongoing therapies in patients with...
- Patients with pulmonary arterial hypertension with or without significant right ventricular dysfunction as assessed by baseline echocardiography and standard of care right heart catheterization
- Functional class 2 or 3 symptoms
- Are able to undergo cardiac MRI, endocardial mapping, and pressure volume measurements
- English speaking
- All patients will be required to have evidence of right ventricular hypertrophy or conduction delay (QRS \> 130ms) on surface ECG
- Preexisting left bundle branch block, current atrial fibrillation, or pacemaker/ defibrillators
- Functional class 4 symptoms
- Patients treated with parenteral or subcutaneous therapies for pulmonary hypertension
- Contraindication to right heart catheterization including significant thrombocytopenia (platelets \ 1.8), or pregnancy as determined by routine screening laboratory work
- Mean pulmonary artery pressure less than 25 mmHg as determined by the right heart catheterization on the day of the study procedure
- Pulmonary capillary wedge pressure greater than or equal to 15 mmHg as determined by the right heart catheterization on the day of the study procedure
- Severe tricuspid regurgitation as determined by baseline transthoracic echocardiogram.
- Left ventricular dysfunction (EF \< 50%) as determined by baseline transthoracic echocardiogram.
- Inability to complete cardiac MRI or transthoracic echocardiography
- Patients with confounding systemic disease specifically portopulmonary hypertension and scleroderma associated pulmonary hypertension
- Patients otherwise deemed not appropriate for the study as determined by the study investigators
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.