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临床试验/NCT06751082
NCT06751082招募中不适用

Sotatercept Pulmonary Hypertension Observational Registry

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年1月20日最近更新:
适应症

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

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert P. Frantz

Principal Investigator

Mayo Clinic

研究点 (1)

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