Goal Oriented Strategy to Preserve Ejection Fraction Trial

NCT03236818 | Unknown Phase 4

• 1 other identifier: NL41878.029.13
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective long term feasibility study we examine whether a goal oriented therapeutic strategy that is able to preserve right ventricular function will result in improved clinical outcome in patients with pulmonary arterial hypertension. We hypothesize that right ventricular function can only be preserved when early and aggressive medical combination therapy not only reduces pulmonary vascular resistance but also pulmonary pressures.

Conditions

Pulmonary Arterial Hypertension

Keywords

pulmonary arterial hypertension; right ventricle; MRI; medical combination therapy

Outcome Measures

Primary Outcomes (1)

• Change in right ventricular ejection fraction

  The primary endpoint will be change in right ventricular ejection fraction (RVEF) during 2 years of follow-up.

  4,12, 24 months of follow-up

Secondary Outcomes (5)

• pulmonary vascular resistance

  4,12, 24 months of follow-up

• mPAP

  4,12, 24 months of follow-up

• Cardiac output in L/min (Thermodilution method)

  4,8, 12, 24 months of follow-up

• Exercise capacity

  4,8, 12, 24 months of follow-up

• New York Heart Association functional class

  4,8, 12, 24 months of follow-up

Other Outcomes (2)

• NT-proBNP

  4,8, 12, 24 months of follow-up

• Quality of Life by SF-36 questionnaire

  4,8, 12, 24 months of follow-up

Study Arms (1)

Upfront combination therapy

OTHER

Combination of an ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan)

Drug: ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan)

Interventions

ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan) DRUG

Combination of an ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan)

Upfront combination therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic or heritable pulmonary arterial hypertension
• New York Heart Association (NYHA) functional class II or III

You may not qualify if:

• Other causes of pulmonary arterial hypertension (i.e. collagen vascular disease, congenital heart disease, chrono-thromboembolic pulmonary hypertension, pulmonary venous hypertension, left heart failure, hypoxemic lung disease)

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VU University Medical Center, dept Pulmonary diseases

Amsterdam, 1081 HV, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Sildenafil Citrate; Tadalafil; Bosentan; macitentan

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbolines; Pyridines; Indole Alkaloids; Indoles; Heterocyclic Compounds, 3-Ring; Benzenesulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrimidines

Study Officials

• Anton Vonk Noordegraaf, MD, PhD

  VU University Medical Center, department of pulmonary diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Principal Investigator

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: August 2, 2017
• Study Start: May 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 2, 2017

Record last verified: 2017-07

Locations

NL (1)