Clinical Trials Logo
  1. Home
  2. Pulmonary Arterial Hypertension
  3. NCT05861479
  4. Details
NCT05861479 Clinical Trial

Prognostic Value of Estimated Plasma Volume in Pulmonary Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:
Assessment of the Prognostic Value of the Estimation of Plasma Volume or Its Variation in Patients With Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) After Acute Right Heart Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05861479
Other study ID # 2022PI167
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date April 1, 2023

Study information
Verified date April 2023
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Assessment of the prognostic value of the estimation of plasma volume or its variation in patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH) after acute right heart failure.

Description:

The aim of the study is to show that a low plasma volume status, assessed by the Strauss (estimated plasma volume variation) and the Duarte (instantaneous estimated plasma volume) formulas evaluated during acute right heart failure in patients presenting with PAH or CTEPH, is associated with better long-term outcomes. Optimization of plasma volume is important for patients with PAH and CTEPH and constitutes a prognostic factor. However, plasma volume status can be difficult to assess in clinical practice. Different formulas have been developed and have shown interest in patients with congestive heart failure with an association between plasma volume estimation and long-term prognosis. Acute right heart failure may occur in patients with PAH and CTEPH. Thus, the investigators plan to study the prognostic value of these formulas evaluating plasma volume, in patients with PAH or CTEPH, after acute right heart failure.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date April 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients with confirmed diagnosis of PAH or CTEPH, referred to the medical department of the investigators 2. Patient with acute right heart failure defined by at least 2 of the following clinical features: worsening of peripheral oedema, development or increase of ascites, weight gain of more than 2.5 kg in 1 week preceding the visit and decline in one NYHA functional class compared to the previous stable state Exclusion Criteria: 1) Patients with another cause of pulmonary hypertension than PAH or CTEPH, either groups 2, 3 or 5 of the current clinical classification of pulmonary hypertension

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome
Type Measure Description Time frame Safety issue
Primary Survival Death From the first visit to 1st April 2023
Primary Recurrence of acute right heart failure Hospital admission for acute right heart failure From the first visit to 1st April 2023
Primary Acute right heart failure-free survival First event: death or hospital admission for acute right heart failure From the first visit to 1st April 2023
See also
  Status Clinical Trial Phase
Completed NCT04076241 - Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension N/A
Completed NCT05521113 - Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
Recruiting NCT04972656 - Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension N/A
Completed NCT04908397 - Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension Phase 1
Active, not recruiting NCT03288025 - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE) N/A
Completed NCT01959815 - Novel Screening Strategies for Scleroderma PAH
Recruiting NCT04266197 - Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study Phase 2
Active, not recruiting NCT06092424 - High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA) N/A
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Terminated NCT02060487 - Effects of Oral Sildenafil on Mortality in Adults With PAH Phase 4
Terminated NCT02253394 - The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study Phase 4
Withdrawn NCT02958358 - FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan N/A
Terminated NCT01953965 - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. Phase 2
Not yet recruiting NCT01649739 - Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost Phase 4
Withdrawn NCT01723371 - Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children Phase 1/Phase 2
Unknown status NCT01712997 - Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients Phase 3
Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01165047 - Nitric Oxide, GeNO Nitrosyl Delivery System Phase 2
Completed NCT00942708 - Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension Phase 2
Completed NCT00963001 - Effect of Food on the Pharmacokinetics of Oral Treprostinil Phase 1