right ventricular hypertrophy associated with COPD or Interstitial Lung Disease and pulmonary hypertension MedDRA version: 17.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 17.1 Level: PT Classification code 10022611 Term: Interstitial lung disease
Conditions
Sponsors
University of Dundee/ NHS Tayside
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •participant is willing and able to give informed consent are aged 18 years or over • previously diagnosed with COPD or ILD • screening echocardiography based diagnosis of PH and/or RVH (RVSP>25mmHg, and/or PAT 5.5mm) stable lung disease medication for at least two weeks prior to consent - women of child bearing potential must agree to shceduled pregnancy testing prior to and during study treatment period and to use an appropraite method of contraception if sexually active Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: - patients who are uinable to give informed consent • documented intolerance or allergy to allopurinol - objection to taking capsules made from animal sourced gelatine • left Ventricular Ejection Fraction <45% on echocardiography screening • severe aortic stenosis on echocardiography screening • already had gout or currently taking allopurinol • severe hepatic disease • renal disease; CKD class 3B or greater • taking prohibited medication:azathioprine, 6 mercaptopurine, or theophylline • malignancy (receiving active treatment) or other life threatening diseases • pregnant or lactating • any contraindication to MRI (claustrophobia, metal implants) • patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days will be excluded • women unwilling to agreet to use an appropriate method of contraception during the study treatment period if sexually active • any other considered by a study physician to be inappropriate for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective will be to see if Allopurinol can improve right ventricular hypertrophy in patients with pulmonary hypertension associated with COPD or interstitial lung disease(ILD). This will be done by measuring the size of the right side of the heart muscle with an MRI scan before and after one years of treatment with allopurinol or placebo. ; Secondary Objective: The secondary objectives are to assess the effect of allopurinol on other functions of the heart, such as its pumping ability and the size of the left side of the heart This will be measured by scanning the heart using ultrasound and MRI scans, in patients with COPD or ILD and pulmonary hypertension. We will also assess the effect of allopurinol exercise capacity pre and post six minute walk test and how well the participants lungs are functioning with respect to how much oxygen is available in their blood and how well their lungs are working doing breathing tests. We will also assess if allopurinol improves quality of life in these participants. We will also assess the safety of allopurinol in COPD or ILD and its effects on inflammatory and other blood markers in COPD or ILD. ;Primary end point(s): The primary outcome is to determine if allopurinol induces a change in Right Ventricular Mass Index in patients with COPD or ILD associated Pulmonary Hypertension when compared to placebo.;Timepoint(s) of evaluation of this end point: 12 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes are: • To determine if there is a change in RVEDV, RVESV, RVEF, LV Mass, LVESV, LVEDV, LVEF or pulmonary compliance with allopurinol in COPD/ILD patients compared with placebo. • To determine if there is a difference in pulmonary artery pressure, RVSP, or PAT with allopurinol compared with placebo as measured by both echocardiography and/or MRI. • To determine if allopurinol improves oxygen saturation as measured pre and post 6MWT in COPD/ILD compared with placebo. • To determine if allopurinol improves exercise capacity as measured by 6MWT in COPD/ILD compared with placebo. • To determine if there is an improvement in quality of life measures in COPD/ILD with allopurinol compared to placebo. • To determine if there are changes in inflammatory and other blood markers, in COPD/ILD with allopurinol compared with placebo. ;Timepoint(s) of evaluation of this end point: 12 MONTHS FOR ALL OF ABOVE | — |
Countries
United Kingdom
Contacts
Public ContactStephen McSwiggan
University of Dundee, Tayside Clinical Trials Unit
Outcome results
None listed