Sotatercept Pulmonary Hypertension Observational Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- EmPHasis10 Questionnaire
研究概览
简要总结
The purpose of this study seeks to describe the real world initial experience with sotatercept in the treatment of pulmonary hypertension.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18 or greater who are being treated with sotatercept in the Mayo Pulmonary hypertension clinic.
排除标准
- •Adults lacking capacity to consent
结局指标
主要结局
EmPHasis10 Questionnaire
时间窗: Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
The EmPHasis10 Questionnaire consists of 10 questions to assess quality of life. The scores can range from 0-50, a higher score indicates a worse quality of life.
Number of pulmonary hypertension vasodilator medications taken by a subject
时间窗: Baseline, Year 10
Pulmonary hypertension vasodilator medications are used to decrease pressure in the pulmonary arteries.
Number of patients to have a change in dose of prostanoid medications
时间窗: Baseline, Year 10
A change in dose of prostanoid medications will be determined by a change from baseline dosage.
Number of patient hospitalizations
时间窗: Baseline, Year 10
Number of patient hospitalizations will be determined by the number of patients admitted into the hospital.
Number of patients to cease therapy sessions
时间窗: Baseline, Year 10
Cease of therapy session will be determined by a patient's termination of all therapy sessions
Number of patients to discontinue prostanoid therapy
时间窗: Baseline, Year 10
Number of patients to discontinue prostanoid therapy will be determined by a patients termination of all prostanoid therapy
Number of patients with bleeding complications
时间窗: Baseline, Year 10
Bleeding complications include nosebleeds not requiring ER visit or transfusion, epistaxis or GI hemorrhage requiring ED visit/hospitalization.
Number of patients to develop Skin telangiectasias
时间窗: Baseline, Year 10
Development of skin telangiectasias includes new development, worsening, or distribution
Change in 6 min walk distance
时间窗: Baseline, Year 10
6 minute walk distance will be measured in meters (m).
Number of patients to have a change in hemodynamics
时间窗: Baseline, Year 10
Change in hemodynamics include the change in Blood Flow, Blood Pressure, Cardiac Output, Vascular Resistance, Perfusion
Change in Right Ventricular Systolic Pressure (RVSP)
时间窗: Baseline, Year 10
Right Ventricular Systolic Pressure is the pressure in the right ventricle during contraction. RVSP will be measured in mmHg.
Right Ventricular Strain
时间窗: Baseline, Year 10
Right Ventricular Strain refers to strain on the right ventricle during contraction. Right Ventricular Strain will be determined by echocardiogram and measured as a percentage.
Change in Right Ventricle (RV) function
时间窗: Baseline, Year 10
Change in RV function will be determined by echocardiogram and measured as a percentage.
Change in capacitance
时间窗: Baseline, Year 10
Capacitance is the ability for blood vessels to store and release blood. capacitance will be determined by echocardiogram.
Change in tricuspid regurgitation
时间窗: Baseline, Year 10
Tricuspid regurgitation is the regurgitation of blood into the right atrium during contraction of the heart.
Change in Stroke Volume (SV)
时间窗: Baseline, Year 10
Stroke Volume is calculated by End-Diastolic Volume (EDV)-End-Systolic Volume (ESV) and measured in mL
Change in Pulse Pressure (PP)
时间窗: Baseline, Year 10
Pulse Pressure is calculated by PP=systolic blood pressure (SBP) - diastolic blood pressure (DBP) and measured in mmHg
Change in functional class
时间窗: Baseline, Year 10
Functional class refers to the severity of patients heart condition. A change in class would refer to the increase or decrease in severity of the condition.
Number of patients to survive without receiving a transplant
时间窗: Baseline, Year 10
A transplant is defined as receiving an organ or tissue from a donor.
次要结局
未报告次要终点
研究者
Robert P. Frantz
Principal Investigator
Mayo Clinic
