Vasopressor Agents in Pulmonary Hypertension Crisis

Comparison of the Efficacy and Safety of Dopamine, Norepinephrine and Epinephrine in the Treatment of Pulmonary Hypertensive Crisis Under Hemodynamic Monitoring

Comparison of the efficacy and safety of three vasoactive agents-dopamine, norepinephrine, and epinephrine-in the treatment of patients with pulmonary hypertension crisis: prospective, randomised controlled trial monitored by haemodynamic monitoring

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension, Pulmonary; Chronic Thromboembolic Pulmonary Hypertension (CTEPH); Pulmonary Arterial Hypertension (PAH)
• Intervention / Treatment: Drug: Norepinephrine; Drug: Dopamine; Drug: Epinephrine

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qing Gu,MD; Phone Number: +86 010-88392814; Email: guqingfw@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 10037
      • Chinese Academy of Medical Sciences, Fuwai Hospital
      • Contact: Qing Gu,MD; Phone Number: +86 010-88392814; Email: guqingfw@126.com
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Guangdong Provincial people's hospital
      • Contact: Li Huang; Phone Number: +86 020-83827812; Email: huangli1991ly@126.com
  • Wuhan
    • Wuhan, Wuhan, China, 430072
      • Zhongnan Hospital of Wuhan University
      • Contact: Gangcheng Zhang; Phone Number: +86 027-68756878; Email: zgcsir@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age > 18 years old;
2. Signed informed consent form;
3. Confirmed diagnosis of arterial pulmonary hypertension (PAH) and/or chronic thromboembolic pulmonary hypertension (CTEPH);
4. Presenting with manifestations of pulmonary hypertensive crisis;
5. Receiving both diagnosis and treatment in-hospital;
6. No intravenous administration of the vasopressor drugs (including dopamine, norepinephrine, and epinephrine) under study at enrollment.

Exclusion Criteria:

1. At SCAI stage D or stage E ;
2. Patients who only receive a diagnosis but no treatment in the hospital;
3. Uncontrolled hyperthyroidism;
4. Complicated with angle-closure glaucoma;
5. Hypersensitivity to the study drug;
6. Ongoing use of halogenated hydrocarbon general anesthetics such as cyclopropane and halothane;
7. Ongoing use of monoamine oxidase inhibitor (MAOI) antidepressants or anti-Parkinson drugs (phenelzine, tranylcypromine, isocarboxazid, moclobemide);
8. Pregnancy;
9. Already receiving the vasopressor drugs (dopamine, norepinephrine, epinephrine) under study at enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Norepinephrine group; The initial dose is 0.02 mg/kg/min of norepinephrine; each dose adjustment (increase or decrease) is 0.02 mg/kg/min of norepinephrine; the maximum dose of norepinephrine is 0.2 mg/kg/min.	Drug: Norepinephrine; The initial dose is 0.02 mg/kg/min of norepinephrine; each dose adjustment (increase or decrease) is 0.02 mg/kg/min of norepinephrine; the maximum dose of norepinephrine is 0.2 mg/kg/min.
Experimental: Dopamine group; The initial dose is 2 μg/kg/min of dopamine; each dose adjustment (increase or decrease) is 2 μg/kg/min of dopamine; the maximum dose of dopamine is 20 μg/kg/min.	Drug: Dopamine; The initial dose is 2 μg/kg/min of dopamine; each dose adjustment (increase or decrease) is 2 μg/kg/min of dopamine; the maximum dose of dopamine is 20 μg/kg/min
Experimental: Epinephrine group; The initial dose is 0.02 μg/kg/min of epinephrine; each adjustment (increase or decrease) is 0.02 μg/kg/min of epinephrine; the maximum dose of epinephrine is 0.2 μg/kg/min	Drug: Epinephrine; The initial dose is 0.02 μg/kg/min of epinephrine; each adjustment (up or down) is 0.02 μg/kg/min of epinephrine; the maximum dose of epinephrine is 0.2 μg/kg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality within 28 days	28 days after enrolment

Secondary Outcome Measures

Outcome Measure	Time Frame
Haemodynamic parameters	Haemodynamic parameters at H0, H6, H24, H48 and H72
Severe arrhythmia (ventricular tachycardia, ventricular fibrillation)	Time of onset of severe arrhythmia
Adverse effects of vasopressors	Time at which adverse effects occur
Arterial Blood Gas Analysis	H0, H6, H24, H48, H72, Day 7, Day 14, Day 21, Day 28 (if the length of hospital stay is between 7 and 28 days, a test must be performed on the day of discharge)
Vital Signs	Record at H0, H2, H4, H6, H12, H24, H48 and H72 after administration of medication; thereafter, record once every 24 hours until the day of discharge
BNP or NT-proBNP	H0, H24, H48, H72, Day 7, Day 14, Day 21, Day 28 (if the length of hospital stay is between 7 and 28 days, a test must be performed on the day of discharge)
Echocardiographic parameters	H0, H24, H48, H72, Day 7, Day 14, Day 21, Day 28 (if the length of hospital stay is between 7 and 28 days, a measurement must be taken on the day of discharge)

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 21, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Heart Failure; Vascular Diseases; Cardiovascular Diseases; Efficacy and Safety; Norepinephrine; Dopamine; Pulmonary Arterial Hypertension; Epinephrine; Chronic thromboembolic pulmonary hypertension; Hypertension, Pulmonary; Pulmonary circulation; Haemodynamic Monitoring
• Additional Relevant MeSH Terms: Heart Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Arterial Hypertension; Heart Failure; Cardiovascular Diseases; Vascular Diseases; Hypertension, Pulmonary; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amines; Catechols; Phenols; Benzene Derivatives; Alcohols; Amino Alcohols; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Norepinephrine; Epinephrine; Dopamine
• Other Study ID Numbers: 2024ZD0526703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No