Features of the Clinical Course and Prognosis in Patients With Idiopathic Pulmonary Hypertension When Using Modern Strategies of Specific Therapy

NCT06587074 | Active Not Recruiting

• 1 other identifier: SHAM-3232
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be performed based on a retrospective analysis of the cases of 150-170 patients with IPAH observed at the Research Institute of Clinical Cardiology over the past 10 years, for a comparative assessment of the survival of groups of patients with IPAH diagnosed in the period 2004-2013 and 2014-2023. The demographic, clinical, functional, hemodynamic characteristics of patients, comorbidity, blood biomarker levels, received PAH-specific and symptomatic therapy will be assessed in order to determine the clinical characteristics of patients with IPAH. The prospective part of study will include 50 patients with IPAH.

Conditions

Idiopathic Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Mortality in 3 years after diagnosed IPAH

  3 years

Study Arms (2)

Group 1

Group 2

Eligibility Criteria

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

Study Population

IPAH diagnosed patients in 2004-2023

You may qualify if:

• age over 18 years;
• verified diagnosis of IPAH

You may not qualify if:

• age under 18 years;
• Other etiology op PAH,
• ischemic heart disease confirmed by MSCT of the coronary arteries or coronary angiography;
• diseases of the musculoskeletal system that prevent 6MWT
• severe liver dysfunction (more than 9 points on the Child-Pugh scale, class C)
• severe renal dysfunction (CC less than 15 ml/min), need for hemodialysis

Sponsors & Collaborators

• Russian Cardiology Research and Production Center: lead

Study Sites (1)

Russian National Cardilogy Reasearch Center

Moscow, 121552, Russia

Location

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tamila V Martyunuk, Yes

  Russian National Cardiology Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of pulmonary hypertension department

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: May 30, 2023
• Primary Completion: August 14, 2024
• Study Completion: July 22, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

RU (1)