NCT04194632Toboroz
Right Ventricular Pacing in Pulmonary Arterial Hypertension
Right Ventricular Pacing to Treat Right Ventricular Failure: A Single Arm Hemodynamic Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 2.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 16 (tervezett)
- Első benyújtás
- 2019. dec. 9.
- Kezdés
- 2021. jan. 1.
- Elsődleges befejezés
- 2027. jan. 1.
- Fő szponzor
- University of California, San Francisco
- Betegségek
- Pulmonális artériás hipertónia, Szívelégtelenség
- NCT-szám
- NCT04194632
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 16
- 2021. jan. 1. és az elsődleges befejezés (2027. jan. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Patients treated with parenteral or subcutaneous therapies for pulmonary hypertension
Más betegség
- 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
Laborértékek
- Contraindication to right heart catheterization including significant thrombocytopenia (platelets < 50,000), coagulopathy (INR > 1.8), or pregnancy as determined by routine screening laboratory work
Egyéb
- 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
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of California San Francisco | San Francisco | Egyesült Államok | Toboroz |
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