Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05716984
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-10-10
First Post:
2022-09-14
Brief Title:
rhBNP in Type 3 Pulmonary Hypertension
Sponsor:
Shengjing Hospital
Organization:
Shengjing Hospital
Study Overview
Official Title:
A Prospective Multicenter Randomized Double-blind Placebo-controlled Clinical Study on the Efficacy and Safety of Recombinant Human Brain Natriuretic Peptide in Improving Type 3 Pulmonary Hypertension
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pulmonary hypertension is a common clinical syndrome which seriously affects the quality of life and survival of patients Pulmonary hypertension PH is defined as an increase in mean pulmonary arterial pressure mPAP to 20 mmHg at rest as measured invasively by right heart catheterisation RHC Pulmonary hypertension can be divided into five types among which pulmonary hypertension caused by chronic pulmonary diseases andor hypoxia is called Group 3 pulmonary hypertension which is the most important factor of pulmonary heart disease The drugs currently used to treat patients with PAH prostanoids endothelin receptor antagonists phosphodiesterase-5 inhibitors sGC stimulators have not been sufficiently investigated in Group 3 PH except indirect treatment methods such as improving hypoxia and controlling infection
Recombinant human brain natriuretic peptide rhBNP is a biological agent with a molecular weight of 3664Da synthesized by DNA technology It is availble in China It has many functions such as diuresis vasodilation inhibition of renin-angiotensin-aldosterone and sympathetic nervous systems etc RhBNP has been suggested in patients with acute myocardial infarction and congestive heart failure In view of the dilating effect of rhBNP on pulmonary vessels it is speculated that rhBNP may reduce type 3 pulmonary hypertension Based on this hypothesis we conducted a preliminary clinical trial The results showed that compared with the placebo group after rhBNP was continuously pumped for 24 hours the pulmonary artery hemodynamic indexes continuously monitored by Swan-Ganz catheter were significantly improved In view of the pharmacological effect of rhBNP and our previous clinical trial results this study intends to conduct a prospective multicenter placebo-controlled double-blind clinical trial to evaluate the efficacy and safety of rhBNP in the treatment of patients with group 3 pulmonary hypertension
Recombinant human brain natriuretic peptide rhBNP is a biological agent with a molecular weight of 3664Da synthesized by DNA technology It is availble in China It has many functions such as diuresis vasodilation inhibition of renin-angiotensin-aldosterone and sympathetic nervous systems etc RhBNP has been suggested in patients with acute myocardial infarction and congestive heart failure In view of the dilating effect of rhBNP on pulmonary vessels it is speculated that rhBNP may reduce type 3 pulmonary hypertension Based on this hypothesis we conducted a preliminary clinical trial The results showed that compared with the placebo group after rhBNP was continuously pumped for 24 hours the pulmonary artery hemodynamic indexes continuously monitored by Swan-Ganz catheter were significantly improved In view of the pharmacological effect of rhBNP and our previous clinical trial results this study intends to conduct a prospective multicenter placebo-controlled double-blind clinical trial to evaluate the efficacy and safety of rhBNP in the treatment of patients with group 3 pulmonary hypertension
Detailed Description:
The study was divided into three stages including screening period 3 days treatment period 72 hours and follow-up period 10 2 days and 30 5 days Clinical visits were conducted for 5 times including admissionscreening - V0 V1 randomization the end of treatment V2 and 10 2 days before discharge V3 in the research center The telephone interview will be followed up and evaluated on the 30th 5 day V4
After the subjects signed the informed consent form they completed all screening tests The qualified subjects immediately started the basic treatment of Group 3 pulmonary hypertension Three days later they underwent right heart echocardiography and Swan-Ganz catheterization The qualified subjects who met all the inclusion criteria and did not meet all the exclusion criteria were randomly allocated to the rhBNP treatment group or the placebo group at a ratio of 11 and the course of treatment was 72 hours Due to the potential risk of hypotension blood pressure should be monitored regularly during study drug administration After the treatment continue to follow up once by telephone and the whole study period is 33 5 days During the whole treatment period the study doctor recorded symptoms vital signs physical examination and adverse reactions AESAE according to the requirements of the visit
Except for emergency safety issues no protocol violation or exemption is allowed Therefore the study must be carried out according to the study design including the operation items specified in the time and event table
After the subjects signed the informed consent form they completed all screening tests The qualified subjects immediately started the basic treatment of Group 3 pulmonary hypertension Three days later they underwent right heart echocardiography and Swan-Ganz catheterization The qualified subjects who met all the inclusion criteria and did not meet all the exclusion criteria were randomly allocated to the rhBNP treatment group or the placebo group at a ratio of 11 and the course of treatment was 72 hours Due to the potential risk of hypotension blood pressure should be monitored regularly during study drug administration After the treatment continue to follow up once by telephone and the whole study period is 33 5 days During the whole treatment period the study doctor recorded symptoms vital signs physical examination and adverse reactions AESAE according to the requirements of the visit
Except for emergency safety issues no protocol violation or exemption is allowed Therefore the study must be carried out according to the study design including the operation items specified in the time and event table
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None