NCT04194632Recruiting
Right Ventricular Pacing in Pulmonary Arterial Hypertension
Right Ventricular Pacing to Treat Right Ventricular Failure: A Single Arm Hemodynamic Study
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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. To date, however, there are no proven treatments that target RV contractile function. Echocardiographic studies of RV dysfunction in the setting of pressure overload have demonstrated intra and interventricular dyssynchrony even in the absence of overt right bundle branch block (RBBB). Electrophysiologic studies of patients with chronic thromboembolic disease (CTEPH) at the time of pulmonary endarterectomy have shown prolongation of action potential and slowed conduction in the right ventricle which has correlated with echocardiographic measures of dyssynchrony. Cardiac MRI measures of RV strain in patients with PAH demonstrated simultaneous initiation of RV and left ventricular (LV) contraction, but delayed peak RV strain suggesting that interventricular dyssynchrony is a mechanical rather than electrical phenomenon. Prior studies of RV dysfunction in an animal model, computer model, congenital heart disease, and CTEPH have suggested acute hemodynamic benefits of RV pacing. However, RV pacing has not been studied in patients with PAH. Furthermore, it remains unclear if pacing particular regions of the RV can achieve a hemodynamic benefit and what cost this hemodynamic improvement may incur with regards to myocardial energetics and wall stress. Therefore, the investigators propose to examine RV electrical activation in PAH, map the area of latest activation, and then evaluate the hemodynamic and energetic effects of RV pacing in these patients.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 9 Dec 2019
- Start date
- 1 Jan 2021
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- University of California, San Francisco
- NCT number
- NCT04194632
What you commit to
- Study type: Interventional
- Planned participants: 16
- From 1 Jan 2021 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients treated with parenteral or subcutaneous therapies for pulmonary hypertension
Other illness
- 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
- Inability to complete cardiac MRI or transthoracic echocardiography
- Patients with confounding systemic disease specifically portopulmonary hypertension and scleroderma associated pulmonary hypertension
Lab values
- Contraindication to right heart catheterization including significant thrombocytopenia (platelets \< 50,000), coagulopathy (INR \> 1.8), or pregnancy as determined by routine screening laboratory work
Other
- Preexisting left bundle branch block, current atrial fibrillation, or pacemaker/ defibrillators
- Functional class 4 symptoms
- Severe tricuspid regurgitation as determined by baseline transthoracic echocardiogram.
- Left ventricular dysfunction (EF \< 50%) as determined by baseline transthoracic echocardiogram.
- Patients otherwise deemed not appropriate for the study as determined by the study investigators
Who the study is looking for
- 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 diagnosed pulmonary arterial hypertension.
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.