Vasopressor Agents in Pulmonary Hypertension Crisis

NCT07667829 | Not Yet Recruiting DMC

• 1 other identifier: 2024ZD0526703
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Pulmonary Arterial Hypertension (PAH); Chronic Thromboembolic Pulmonary Hypertension (CTEPH); Hypertension, Pulmonary

Keywords

Hypertension, Pulmonary; Cardiovascular Diseases; Vascular Diseases; Dopamine; Norepinephrine; Epinephrine; Haemodynamic Monitoring; Efficacy and Safety; Chronic thromboembolic pulmonary hypertension; Heart Failure; Pulmonary circulation; Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• All-cause mortality within 28 days

  28 days after enrolment

Secondary Outcomes (7)

• 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

Study Arms (3)

Norepinephrine group

EXPERIMENTAL

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

Dopamine group

EXPERIMENTAL

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

Epinephrine group

EXPERIMENTAL

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

Interventions

Norepinephrine DRUG

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.

Norepinephrine group

Dopamine DRUG

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

Dopamine group

Epinephrine DRUG

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

Epinephrine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (3)

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, 10037, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510180, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Wuhan, 430072, China

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Cardiovascular Diseases; Vascular Diseases; Heart Failure

Interventions

Norepinephrine; Dopamine; Epinephrine

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Heart Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Qing Gu,MD

CONTACT

+86 010-88392814; guqingfw@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Chair

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 25, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)