Pulmonary Arterial HypertensionPhase 2NCT01447628
IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients
A Phase 2 study testing Saline and Ferinject or CosmoFer in people with Pulmonary Arterial Hypertension and Iron Deficiency, run by Imperial College London at 5 sites in 3 countries.
Trial summary
This study will establish whether intravenous iron replacement has clinical benefit in idiopathic pulmonary arterial hypertension. A 24-week double-blind, randomised, placebo-controlled, crossover study will investigate whether a single dose of 1g of Ferinject® or CosmoFer improves cardiopulmonary haemodynamics… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Iron Deficiency
- What is being tested?
- Saline and Ferinject or CosmoFer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 29 Mar 2011to 22 Dec 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Unable to provide informed consent.
- Clinically-significant renal disease (Creatinine clearance < 30 ml/min per 1.73 m2 calculated from Chronic Kidney Disease-Epidemiology Collaboration (CKD-Epi) http://www.qxmed.com/renal/Calculate-CKD-EPI-GFR.php) or liver disease (including serum transaminases > 3 times upper limit of normal).
- Haemoglobin concentration <10 g/dl.
- Patients will be excluded if any single parameter (iron, ferritin or transferrin saturation) exceeds 1x upper limit of normal (ULN) in the local lab reference range.
- Patients with moderate to severe hypophosphatemia as defined as <0.65mmol/L
- Known to have haemoglobinopathy e.g. sickle cell disease, thalassaemia.
Show all 17Show fewer
- Admission to hospital related to PAH or change in PAH therapy within 1 month prior to Screening.
- Evidence of left ventricular disease or significant lung disease on high-resolution Computed Tomography (CT) scanning or lung function as judged by the investigator
- Acute or chronic infection or inflammation.
- Significant uncontrolled asthma as judged by the investigator, eczema or atopic allergies.
- Females who are lactating or pregnant.
- Individuals known to have Human Immunodeficiency Virus (HIV), Hepatitis B or C or Creutzfeld-Jakob disease.
- Known hypersensitivity to Ferinject® or any of its excipients.
- Evidence of disturbances in utilisation of iron.
- Significant blood loss (e.g. Gastro-intestinal bleed) within the last 3 months or history of menorrhagia.
- Unable to perform a Cardiopulmonary Exercise Test i.e. due to syncope or musculoskeletal factors.
- Patients who have received an investigational medicinal product within 30 days of entering the baseline visit
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United Kingdom3 sites
Papworth Hospital NHS Foundation Trust
Cambridge
Hammersmith Hospital, Imperial College NHS Trust
London
Royal Hallamshire Hospital
Sheffield
About this study
Official title: What is the Effect of Intravenous Iron Supplementation on Cardiopulmonary Haemodynamics, Exercise Capacity and Quality of Life in Patients With IPAH and Iron Deficiency?
This study will establish whether intravenous iron replacement has clinical benefit in idiopathic pulmonary arterial hypertension.
A 24-week double-blind, randomised, placebo-controlled, crossover study will investigate whether a single dose of 1g of Ferinject® or CosmoFer improves cardiopulmonary haemodynamics, exercise capacity and quality of life and is well-tolerated.
IV iron formulation used in Europe - Ferinject IV iron formulation used in China - CosmoFer
Read the detailed description
These results represent the outcome of two separate clinical trials which were conducted in collaboration, led by Imperial College and Fuwai, China respectively. The protocols were analogous, although in China Endurance Cardio-Pulmonary Exercise Testing (CPET) was not done and instead of Ferinject/Placebo being infused over 15 minutes, Cosmofer/Placebo was infused over 4-6 hours.
The study analyses were performed as Intention to Treat, except for patients 6009-6017 as described below. The study was a cross-over design and results are presented for 2 groups based on the participants' study timepoint, and presented separately for the two study datasets (Europe and Fuwai). A meta-analysis was conducted for the combined data where possible and the relevant p-values have been provided.
Iron results in the European dataset are taken from blood results which were collected centrally and analysed by one laboratory at Imperial College London. N-Terminal B-type natriuretic peptide (NT-PRO-BNP) and Soluble Transferrin Receptors (STFR) were not done at Fuwai.
The study was conducted according to Good Clinical Practice (GCP), but there were some missing data (imputed using multiple imputation techniques), and also some significant protocol deviations which are summarised below.
Six participants (2003, 3004, 4002-4005) had their endurance CPETs set at incorrect workloads which differed significantly from that achieved at the baseline incremental CPET. These data were therefore treated as missing, and relevant values imputed as per the statistical analysis plan.
Visit 5 CPETs for participants 1008 (Incremental CPET 12 weeks later) 1018 (Endurance CPET 13 days later) and 1019 (Incremental CPET 15 days later) were performed outside the protocol-specified window.
Participant 1014 received placebo at both treatment visits in error. Participant 6017 suffered a suspected allergic reaction to their first infusion and was withdrawn from the study. There was a systemic error where participants 6009-6016 received the opposite to their random-assigned treatment at each time point. These participants were analysed according to the treatment actually received, rather than that originally assigned by randomisation.
- Conditions
- Pulmonary Arterial Hypertension, Iron Deficiency
- Being tested
- Saline, Ferinject or CosmoFer
- Keywords
- Idiopathic pulmonary arterial hypertension (IPAH), Iron deficiency
- Medical subject headings
- Pulmonary Arterial Hypertension, Iron Deficiencies, Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Also called Placebo
intravenous, no active drug
Ferinject or CosmoFerDrug
Also called Intravenous Iron
Intravenous, 1000 mg iron
| Study group | Role | What they receive |
|---|---|---|
| Ferinject or CosmoFer followed by Placebo | Active comparator | IV iron formulation used in Europe - Ferinject - given over 15 minutes
IV iron formulation used in China - CosmoFer - over a period of 4 to 6 hours
IV Iron given at Week 0, Placebo (saline) given at Week 12. Receives: Drug: Saline; Drug: Ferinject or CosmoFer |
| Placebo followed by Ferinject or CosmoFer | Placebo comparator | Placebo comparator
Placebo (saline) given at Week 0, IV Iron given at Week 12. Receives: Drug: Saline; Drug: Ferinject or CosmoFer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exercise Capacity - Endurance
Time measured in seconds from start to end of the endurance bicycle cardiopulmonary exercise testing at 80% of the peak work rate. Peak work rate is determined by that achieved at the baseline incremental cardiopulmonary exercise test (CPET).
Note that this was the primary end-point of the European study. Endurance CPET was not done in China.
Measured: 12 Weeks post study treatment
Change in Resting Pulmonary Vascular Resistance (PVR)
To be measured by cardiac catheterisation in wood units.
Measured: 12 weeks post study treatment
Secondary outcomes (30)
Oxygen Consumption (VO2) Level at Peak 12 Weeks After Study Treatment
Level of VO2 at peak measured during incremental cardio-pulmonary exercise testing
Measured: 12 weeks post study treatment
Oxygen Consumption (VO2) at Metabolic Threshold
Level of VO2 at metabolic threshold measured during incremental cardio-pulmonary exercise test
Measured: 12 weeks post study treatment
Ventilation / Volume of Exhaled Carbon Dioxide (VE/VCO2 Slope)
VE/VCO2 slope measured during incremental cardio-pulmonary exercise testing
Measured: 12 weeks post study treatment
Oxygen Consumption (VO2) / Work Rate (WR) Slope
Level of VO2 / WR Slope measured during incremental cardio-pulmonary exercise testing
Measured: 12 weeks post study treatment
Peak Oxygen (O2) Pulse Rate
O2 pulse rate (amount of oxygen consumed per heart beat) at peak measured during incremental cardio-pulmonary exercise test
Measured: 12 weeks post study treatment
Oxygen Consumption (VO2) at the End of Endurance Cardio-pulmonary Exercise Test (CPET)
Level of VO2 measured at end of endurance cardio-pulmonary exercise test. Note that endurance CPET was not done in China, so this is reported only for the European dataset.
Measured: 12 weeks post study treatment
Oxygen Consumption (VO2) at 3 Minutes
Level of VO2 measured at 3 minutes into endurance cardio-pulmonary exercise test (CPET) Note that endurance CPET was not done in China, hence results are presented only for the European dataset.
Measured: 12 weeks post study treatment
Iron Indices: Serum Iron
Measurement of serum iron
Measured: 12 weeks post study treatment
Iron Indices: Transferrin Saturations
Measurement of serum transferrin saturations. The saturation measures the iron concentration as a proportion of the iron binding capacity of transferrin.
Measured: 12 weeks post study treatment
Iron Indices: Ferritin
Measured level of serum ferritin
Measured: 12 weeks post study treatment
Iron Indices: Soluble Transferrin Receptors (sTfR)
Measure of serum sTfR level. Note that this was not measured in China, hence is reported only for the European dataset.
Measured: 12 weeks post study treatment
6 Minute Walk Test: Distance Walked
Distance in metres walked during standardised and validated 6 minute walk test
Measured: 12 weeks post study treatment
6 Minute Walk Test: Borg Dyspnoea Score After Test
Participant reported score on the modified Borg Dyspnoea scale (0-10) following 6 minute walk test. Higher scores indicate worsened dyspnoea.
Measured: 12 weeks post study treatment
Iron Indices: N-terminal Pro B-type Natriuretic Peptide (NT-pro-BNP)
Measured level of NT-pro-BNP in blood sample. Note that this was not measured in China, hence is presented only for the European dataset.
Measured: 12 weeks post study treatment
Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR Questionnaire): Symptom Score
Participant self reported symptom score using the CAMPHOR questionnaire (0-25). Scores for symptoms range from 0-25, with higher scores indicating worse symptoms.
Note that this was not measured in China, hence is presented only for the European dataset.
Measured: 12 weeks post study treatment
Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR Questionnaire): Activity Score
Participants' self reported score of their own level of activity based on the CAMPHOR questionnaire.
Activity scores range from 0-30, with higher scores indicating more physical limitations Note that this was not measured in China, hence is presented only for the European dataset.
Measured: 12 weeks post study treatment
Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR Questionnaire): QoL Score
Quality of Life score based on the Cambridge Pulmonary Hypertension Outcomes Review (CAMPHOR) questionnaire (0-25).
Scores for QoL range from 0-25, with higher scores indicating worse quality of life Note that this was not measured in China, hence is presented only for the European dataset.
Measured: 12 weeks post study treatment
Mean Right Atrial Pressure (Cardiac Catheter)
Mean right atrial pressure at rest measured by cardiac catheter
Measured: 12 weeks post study treatment
Oxygen Consumption (VO2) Level at Peak
VO2 at peak of Incremental Cardio-pulmonary exercise test in ml/min/kg
Measured: 12 weeks post study treatment
Oxygen Consumption (VO2) at Metabolic Threshold
VO2 at Metabolic Threshold measured during incremental cardio-pulmonary exercise test
Measured: 12 weeks post treatment
Stroke Volume (Cardiac Catheter)
Measurement of stroke volume at rest by cardiac catheter at 12 weeks post treatment
Measured: 12 weeks post treatment
Cardiac Magnetic Resonance Imaging (MRI): Right Ventricular End-diastolic Volume
Cardiac MRI: Right ventricular end-diastolic volumes
Measured: 12 weeks
Cardiac Magnetic Resonance Imaging (MRI): Right Ventricular End Systolic Volume (RVESV)
Cardiac MR: Right ventricular end systolic volume
Measured: 12 weeks
Cardiac Magnetic Resonance Imaging (MRI): Right Ventricular Stroke Volume (RVSV)
Right ventricular stroke volumes assessed by cardiac MRI scan
Measured: 12 weeks
Cardiac Magnetic Resonance Imaging (MRI): Right Ventricular Ejection Fraction (RVEF)
Cardiac MR: Right ventricular ejection fractions
Measured: 12 weeks
Cardiac Magnetic Resonance Imaging (MRI): Left Ventricular End Diastolic Volume (LVEDV)
Cardiac MR: Left Ventricular End Diastolic Volume
Measured: 12 weeks
Cardiac Magnetic Resonance Imaging (MRI): Left Ventricular End Systolic Volume (LVESV)
Cardiac MR: Left Ventricular End Systolic Volume
Measured: 12 weeks
Cardiac Magnetic Resonance Imaging: Left Ventricular Stroke Volume (LVSV)
Cardiac MR: Left Ventricular Stroke Volume
Measured: 12 weeks
Cardiac Magnetic Resonance Imaging (MRI): Left Ventricular Ejection Fraction (LVEF)
Cardiac MR: Left Ventricular Ejection Fraction
Measured: 12 weeks
Cardiac Magnetic Resonance Imaging: Left Ventricular Mass
Cardiac MR: Left Ventricular Mass
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study start29 Mar 2011
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China
- Responsible party
- Sponsor
- Investigators
- Luke Howard, DPhil, FRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447628
- Sponsor's protocol ID
- CRO1811
- Status last verified
- Dec 2021
- First submitted
- 4 Oct 2011
- Last updated
- 7 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Howard LSGE, He J, Watson GMJ, Huang L, Wharton J, Luo Q, Kiely DG, Condliffe R, Pepke-Zaba J, Morrell NW, Sheares KK, Ulrich A, Quan R, Zhao Z, Jing X, An C, Liu Z, Xiong C, Robbins PA, Dawes T, de Marvao A, Rhodes CJ, Richter MJ, Gall H, Ghofrani HA, Zhao L, Huson L, Wilkins MR. Supplementation with Iron in Pulmonary Arterial Hypertension. Two Randomized Crossover Trials. Ann Am Thorac Soc. 2021 Jun;18(6):981-988. doi: 10.1513/AnnalsATS.202009-1131OC.
PubMed 33735594
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Effect of Intravenous Iron Supplementation on Cardiopulmonary Haemodynamics, Exercise Capacity and Quality of Life in Patients With IPAH and Iron Deficiency?
- ClinicalTrials.gov ID
- NCT01447628
- Acronym / sponsor ID
- CRO1811
- Conditions
- Pulmonary Arterial Hypertension, Iron Deficiency
- Keywords
- Idiopathic pulmonary arterial hypertension (IPAH), Iron deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China
- Study start
- 29 Mar 2011 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Posted 7 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will establish whether intravenous iron replacement has clinical benefit in idiopathic pulmonary arterial hypertension.
A 24-week double-blind, randomised, placebo-controlled, crossover study will investigate whether a single dose of 1g of Ferinject® or CosmoFer improves cardiopulmonary haemodynamics, exercise capacity and quality of life and is well-tolerated.
IV iron formulation used in Europe - Ferinject IV iron formulation used in China - CosmoFer
Detailed description
These results represent the outcome of two separate clinical trials which were conducted in collaboration, led by Imperial College and Fuwai, China respectively. The protocols were analogous, although in China Endurance Cardio-Pulmonary Exercise Testing (CPET) was not done and instead of Ferinject/Placebo being infused over 15 minutes, Cosmofer/Placebo was infused over 4-6 hours.
The study analyses were performed as Intention to Treat, except for patients 6009-6017 as described below. The study was a cross-over design and results are presented for 2 groups based on the participants' study timepoint, and presented separately for the two study datasets (Europe and Fuwai). A meta-analysis was conducted for the combined data where possible and the relevant p-values have been provided.
Iron results in the European dataset are taken from blood results which were collected centrally and analysed by one laboratory at Imperial College London. N-Terminal B-type natriuretic peptide (NT-PRO-BNP) and Soluble Transferrin Receptors (STFR) were not done at Fuwai.
The study was conducted according to Good Clinical Practice (GCP), but there were some missing data (imputed using multiple imputation techniques), and also some significant protocol deviations which are summarised below.
Six participants (2003, 3004, 4002-4005) had their endurance CPETs set at incorrect workloads which differed significantly from that achieved at the baseline incremental CPET. These data were therefore treated as missing, and relevant values imputed as per the statistical analysis plan.
Visit 5 CPETs for participants 1008 (Incremental CPET 12 weeks later) 1018 (Endurance CPET 13 days later) and 1019 (Incremental CPET 15 days later) were performed outside the protocol-specified window.
Participant 1014 received placebo at both treatment visits in error. Participant 6017 suffered a suspected allergic reaction to their first infusion and was withdrawn from the study. There was a systemic error where participants 6009-6016 received the opposite to their random-assigned treatment at each time point. These participants were analysed according to the treatment actually received, rather than that originally assigned by randomisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferinject or CosmoFer followed by Placebo | Active comparator | Drug: Saline, Drug: Ferinject or CosmoFerIV iron formulation used in Europe - Ferinject - given over 15 minutes IV iron formulation used in China - CosmoFer - over a period of 4 to 6 hours IV Iron given at Week 0, Placebo (saline) given at Week 12. |
| Placebo followed by Ferinject or CosmoFer | Placebo comparator | Drug: Saline, Drug: Ferinject or CosmoFerPlacebo comparator Placebo (saline) given at Week 0, IV Iron given at Week 12. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Unable to provide informed consent.
- Clinically-significant renal disease (Creatinine clearance < 30 ml/min per 1.73 m2 calculated from Chronic Kidney Disease-Epidemiology Collaboration (CKD-Epi) http://www.qxmed.com/renal/Calculate-CKD-EPI-GFR.php) or liver disease (including serum transaminases > 3 times upper limit of normal).
- Haemoglobin concentration <10 g/dl.
- Patients will be excluded if any single parameter (iron, ferritin or transferrin saturation) exceeds 1x upper limit of normal (ULN) in the local lab reference range.
- Patients with moderate to severe hypophosphatemia as defined as <0.65mmol/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalineAlso: Placebointravenous, no active drug | Drug | Ferinject or CosmoFer followed by Placebo, Placebo followed by Ferinject or CosmoFer |
| Ferinject or CosmoFerAlso: Intravenous IronIntravenous, 1000 mg iron | Drug | Ferinject or CosmoFer followed by Placebo, Placebo followed by Ferinject or CosmoFer |
Primary outcome
Change in Exercise Capacity - Endurance
Time frame: 12 Weeks post study treatment
Time measured in seconds from start to end of the endurance bicycle cardiopulmonary exercise testing at 80% of the peak work rate. Peak work rate is determined by that achieved at the baseline incremental cardiopulmonary exercise test (CPET). Note that this was the primary end-point of the European study. Endurance CPET was not done in China.
Change in Resting Pulmonary Vascular Resistance (PVR)
Time frame: 12 weeks post study treatment
To be measured by cardiac catheterisation in wood units.
30 secondary outcomes
Oxygen Consumption (VO2) Level at Peak 12 Weeks After Study Treatment
Time frame: 12 weeks post study treatment
Oxygen Consumption (VO2) at Metabolic Threshold
Time frame: 12 weeks post study treatment
Ventilation / Volume of Exhaled Carbon Dioxide (VE/VCO2 Slope)
Time frame: 12 weeks post study treatment
Oxygen Consumption (VO2) / Work Rate (WR) Slope
Time frame: 12 weeks post study treatment
Peak Oxygen (O2) Pulse Rate
Time frame: 12 weeks post study treatment
Oxygen Consumption (VO2) at the End of Endurance Cardio-pulmonary Exercise Test (CPET)
Time frame: 12 weeks post study treatment
Oxygen Consumption (VO2) at 3 Minutes
Time frame: 12 weeks post study treatment
Iron Indices: Serum Iron
Time frame: 12 weeks post study treatment
Iron Indices: Transferrin Saturations
Time frame: 12 weeks post study treatment
Iron Indices: Ferritin
Time frame: 12 weeks post study treatment
Iron Indices: Soluble Transferrin Receptors (sTfR)
Time frame: 12 weeks post study treatment
6 Minute Walk Test: Distance Walked
Time frame: 12 weeks post study treatment
6 Minute Walk Test: Borg Dyspnoea Score After Test
Time frame: 12 weeks post study treatment
Iron Indices: N-terminal Pro B-type Natriuretic Peptide (NT-pro-BNP)
Time frame: 12 weeks post study treatment
Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR Questionnaire): Symptom Score
Time frame: 12 weeks post study treatment
Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR Questionnaire): Activity Score
Time frame: 12 weeks post study treatment
Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR Questionnaire): QoL Score
Time frame: 12 weeks post study treatment
Mean Right Atrial Pressure (Cardiac Catheter)
Time frame: 12 weeks post study treatment
Oxygen Consumption (VO2) Level at Peak
Time frame: 12 weeks post study treatment
Oxygen Consumption (VO2) at Metabolic Threshold
Time frame: 12 weeks post treatment
Stroke Volume (Cardiac Catheter)
Time frame: 12 weeks post treatment
Cardiac Magnetic Resonance Imaging (MRI): Right Ventricular End-diastolic Volume
Time frame: 12 weeks
Cardiac Magnetic Resonance Imaging (MRI): Right Ventricular End Systolic Volume (RVESV)
Time frame: 12 weeks
Cardiac Magnetic Resonance Imaging (MRI): Right Ventricular Stroke Volume (RVSV)
Time frame: 12 weeks
Cardiac Magnetic Resonance Imaging (MRI): Right Ventricular Ejection Fraction (RVEF)
Time frame: 12 weeks
Cardiac Magnetic Resonance Imaging (MRI): Left Ventricular End Diastolic Volume (LVEDV)
Time frame: 12 weeks
Cardiac Magnetic Resonance Imaging (MRI): Left Ventricular End Systolic Volume (LVESV)
Time frame: 12 weeks
Cardiac Magnetic Resonance Imaging: Left Ventricular Stroke Volume (LVSV)
Time frame: 12 weeks
Cardiac Magnetic Resonance Imaging (MRI): Left Ventricular Ejection Fraction (LVEF)
Time frame: 12 weeks
Cardiac Magnetic Resonance Imaging: Left Ventricular Mass
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33735594Howard LSGE, He J, Watson GMJ, Huang L, Wharton J, Luo Q, Kiely DG, Condliffe R, Pepke-Zaba J, Morrell NW, Sheares KK, Ulrich A, Quan R, Zhao Z, Jing X, An C, Liu Z, Xiong C, Robbins PA, Dawes T, de Marvao A, Rhodes CJ, Richter MJ, Gall H, Ghofrani HA, Zhao L, Huson L, Wilkins MR. Supplementation with Iron in Pulmonary Arterial Hypertension. Two Randomized Crossover Trials. Ann Am Thorac Soc. 2021 Jun;18(6):981-988. doi: 10.1513/AnnalsATS.202009-1131OC.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke Howard, DPhil, FRCP principal investigator
Imperial College London
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Saline and Ferinject or CosmoFer in people with Pulmonary Arterial Hypertension and Iron Deficiency, run by Imperial College London at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, China, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Exercise Capacity - Endurance (time frame: 12 Weeks post study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01447628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.