Heart Failure, CongestivePhase 1NCT02135861

A Method Validation Study for Evaluation of Novel Treatments Limiting Pulmonary Oedema in Cardiac Failure

A Phase 1 study testing DCE-MRI scans and Gadobutrol in people with Heart Failure, Congestive, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Heart Failure, Congestive
What is being tested?: DCE-MRI scans and Gadobutrol
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteUnited Kingdom
Study dates: 30 Jul 2014to 22 Feb 2017
Phase: Phase 1
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or females over 18 years of age at the time of signing the informed consent.
Body weight >=50 kilogram (kg) and Body Mass Index (BMI) within the range 18.0-40.0 kilogram/square meter (kg/m^2) (inclusive).
Able to understand and comply with protocol requirements, instructions and protocol stated restrictions and is willing to take part in the imaging sessions.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Inclusion Criteria for Heart Failure Group (group 2) - Established diagnosis of mild to moderate heart failure of any aetiology with symptoms defined as corresponding to the New York Heart Association (NYHA) class II or III.
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, brief physical examination, clinical laboratory tests, and Electrocardiogram (ECG).

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Male subjects OR female subjects of non reproductive potential as defined as pre-menopausal females with a documented tubal ligation or hysterectomy, or post-menopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 million international units (MIU)/millilitre (mL) and oestradiol < 40picogram (pg)/mL (< 140 pmol/L) is confirmatory.
50 years of age or over at the time of signing the informed consent
Hospitalized for the management of acute decompensated HF
Presence of dyspnoea at rest or with minimal activity
Presence of at least one of the following signs: Tachypnea with respiratory rate >=20 breaths/min or Rales or crackles audible on auscultation
Chest x-ray with evidence of pulmonary congestion/oedema performed approximately within the last 48 hours (if not available - an additional research CXR may be requested)
Have received at least one treatment with an intravenous diuretic prior to the first MRI scan
Body weight >= 50kg and BMI within the range 18-40 kg/m^2 (inclusive)
Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is willing to take part in the imaging sessions
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Who cannot join

History of known primary pulmonary disease requiring current medication or other therapy.
Orthopnoea of sufficient severity to preclude supine scanning as determined at screening.
Unstable angina within the past 3 months.
Uncontrolled hypertension (resting systolic Blood Pressure (BP) >160 millimeters of mercury (mmHg) or resting diastolic BP >100 mmHg).
Resting hypoxia while breathing room air (Saturation of Oxygen [SaO2] <88%). Exclusion Criteria for Healthy Volunteer Group and Heart Failure Groups
Current smoker, defined as having smoked in the preceding 6 months.

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Contraindication for MRI scanning (as assessed by local MRI safety questionnaire) which includes but not limited to: Intracranial aneurysm clips or other metallic objects; Intra-orbital metal fragments that have not been removed ; Pacemakers or other implanted cardiac rhythm management devices and non-MRI compatible heart valves; Inner ear implants; and History of claustrophobia.
Pregnant females as determined by positive urine human chorionic gonadotropin (HCG) test at screening or any scanning session.
Positive test for drugs of abuse, not due to current prescription drugs as determined by the GSK Medical Monitor and principal investigator (PI), and alcohol screen.
Estimated Creatinine Clearance (Cockcroft-Gault) <60 millilitre (mL)/minute.
End-stage heart failure defined as requiring left ventricular assist devices, intra-aortic balloon pump or any type of mechanical support
Chronic or intermittent renal support therapy (hemodialysis, ultrafiltration, or peritoneal dialysis)
Ongoing or planned intravenous diuretic treatment within 1 hour of MRI scan appointment
History of known primary pulmonary disease requiring current medication or other therapy
Orthopnoea of sufficient severity to preclude supine scanning (as determined by a 15-minute test of lying supine with or without the use of oxygen)
Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to: Intracranial aneurysm clips (except Sugita) or other metallic objects OR intra-orbital metal fragments that have not been removed OR pacemakers or other implanted cardiac rhythm management devices and non-MRI compatible heart valves OR inner ear implants OR history of claustrophobia
Estimated creatinine clearance (Cockcroft-Gault) <40mL/minute
Contraindication to MRI contrast agents
Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden(a significant radiation burden being defined as 10 millisieverts (mSv) in addition to natural background radiation, in the previous 3 years including the dose from this study).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
Cambridge, CB2 2GG

Other trials in United Kingdom

About this study

Official title: An Evaluation of DCE-MRI Measures of Pulmonary Oedema and Vascular Permeability in Healthy Subjects and in Patients With Cardiac Failure: A Methods Validation Study for Evaluation of Novel Treatments Limiting Pulmonary Oedema in Cardiac Failure

Transient receptor potential vanilloid 4 (TRPV4) channel blockade may be promising in the treatment of pulmonary oedema and dyspnoea in heart failure (HF) and acute decompensated heart failure (ADHF) patients by re-establishing the alveolar septal barrier. Dynamic contrast enhanced (DCE) Magnetic Resonance Imaging (MRI) is an established technique for assessing changes in vascular permeability and interstitial water volume. The aim of this study is to establish the potential utility of DCE-MRI as a novel endpoint for dose ranging and proof of mechanism studies of TRPV4 blockers. The DCE-MRI markers of vascular permeability and pulmonary oedema will be measured in subjects with HF (group 2) and healthy volunteers (HV) (group 1) at rest to determine if there is a difference between the two populations. Apart from this, exercise induced changes relative to rest in interstitial volume and exchange rate will be evaluated in both HV and subjects with HF. Additionally, the capability of DCE-MRI to detect changes in interstitial lung fluid in patients with acute decompensated heart failure (ADHF) (group 3) will be investigated. DCE-MRI markers of pulmonary oedema will be assessed when patients are initially hospitalized with ADHF and subsequently after receiving standard of care treatment to determine whether differences can be detected by this methodology.This study will enrol a sufficient number of subjects to have at least 24 subjects in Group 1 and 2 (group 1:12 HV and group 2: 12 subjects with HF) and atleast 5 subjects in Group 3. For each subject, the MRI data must be of sufficient quality to enable DCE-MRI modelling from 2 Sessions. For group 1 and 2, the subjects will have screening visit and 3 MRI sessions. For the first scanning session, subjects will undergo the baseline procedure. The second imaging session will occur approximately one week later to measure within subject variability. A third imaging session (which will be conducted in 2 visits) will incorporate a bicycle exercise challenge prior to the MRI scan, and this third scan will be performed approximately one to three days after the second imaging session. For group 3: Screening will occur during hospitalization for eligibility. Session 1of MRI will be conducted while the subject is still hospitalized. Session 2 will be conducted within 4 weeks of the first scan, when the signs of pulmonary oedema are considered to be resolved. If a subject's pulmonary oedema has not resolved at Session 2, then the subject will be not be scanned by MRI at Session 2 and will be brought back for Session 3 up to 4 weeks after Session 2 for their second MRI.

Conditions: Heart Failure, Congestive
Being tested: DCE-MRI scans, Gadobutrol
Keywords: Acute decompensated heart failure, heart failure, MRI, trpV4 channel inhibitors, pulmonary oedema
Medical subject headings: Heart Failure, Pulmonary Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DCE-MRI scansProcedure or surgery
Subjects will be placed supine in the scanner and will be prepared for intravenous contrast agent administration. The contrast agent is administered using a power injector before imaging.
GadobutrolOther
Gadobutrol at a dose less than or equal to 0.1 millimoles per kilogram (mmol/kg) will be given intravenously as a bolus using a power injector.

Study groups in NCT02135861
Study group	Role	What they receive
Healthy volunteers	Experimental	All subjects will undergo MRI scanning conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system. Receives: Procedure: DCE-MRI scans; Other: Gadobutrol
Heart failure patients	Experimental	All subjects will undergo DCE-MRI scanning conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 T system. Receives: Procedure: DCE-MRI scans; Other: Gadobutrol
Acute decompensated heart failure	Experimental	All subjects will undergo DCE-MRI scanning conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 T system Receives: Procedure: DCE-MRI scans; Other: Gadobutrol

What is being measured

The primary outcome is the main question the study is designed to answer.

Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers at Baseline
Interstitial volume (ve) was measured by DCE-MRI. ve for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal has been presented. Session 1 values were considered as Baseline values.
Measured: Day 1
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers at Baseline
Exchange rate (Ktrans) was measured by DCE-MRI. Ktrans for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal has been presented. Session 1 values were considered as Baseline values.
Measured: Day 1
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Interstitial volume (ve) was measured by DCE-MRI. ve for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal before and following exercise has been presented.
Measured: Day 11
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Exchange rate (Ktrans) was measured by DCE-MRI. Ktrans for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal before and following exercise has been presented.
Measured: Day 11
Change in Interstitial Volume (ve) in ADHF Participants
Interstitial volume (ve) was measured by DCE-MRI. Three participants underwent 3 DCE-MRI scans. The data has been presented for individual participant in each session. The data presented below is only for total lung.
Measured: Up to Week 8
Change in Exchange Rate (Ktrans) in ADHF Participants
Exchange rate (Ktrans) was measured by DCE-MRI. Three participants underwent 3 DCE-MRI scans. The data has been presented for individual participant in each session. The data presented below is only for total lung.
Measured: Up to Week 8

Secondary outcomes (2)

Assessment of Intra-subject Variability in Ve Between Session 1 and Session 2 of DCE-MRI
Coefficient of variation (percentage) of intra-subject variability in Ve between Session 1 and Session 2 for total lung has been presented.
Measured: Day 1 (Session 1) and Day 9 (Session 2)
Assessment of Intra-subject Variability in Ktrans Between Session 1 and Session 2 of DCE-MRI
Coefficient of variation (percentage) of intra-subject variability in Ktrans between Session 1 and Session 2 for total lung has been presented.
Measured: Day 1 (Session 1) and Day 9 (Session 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 201422 Feb 2017

First posted12 May 2014 (estimated)
Study start30 Jul 2014
Primary completion22 Feb 2017
Study completion22 Feb 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.
Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02135861
Sponsor's protocol ID: 201137
Status last verified: Jul 2018
First submitted: 24 Apr 2014
Last updated: 27 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Heart Failure, Congestive trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of DCE-MRI Measures of Pulmonary Oedema and Vascular Permeability in Healthy Subjects and in Patients With Cardiac Failure: A Methods Validation Study for Evaluation of Novel Treatments Limiting Pulmonary Oedema in Cardiac Failure
ClinicalTrials.gov ID: NCT02135861
Acronym / sponsor ID: 201137
Conditions: Heart Failure, Congestive
Keywords: Acute decompensated heart failure, heart failure, MRI, trpV4 channel inhibitors, pulmonary oedema
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 30 Jul 2014 (actual)
Primary completion: 22 Feb 2017 (actual)
Study completion: 22 Feb 2017 (actual)
First posted: 12 May 2014 (estimated)
Results: Posted 27 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Healthy volunteers	Experimental	Procedure: DCE-MRI scans, Other: GadobutrolAll subjects will undergo MRI scanning conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system.
Heart failure patients	Experimental	Procedure: DCE-MRI scans, Other: GadobutrolAll subjects will undergo DCE-MRI scanning conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 T system.
Acute decompensated heart failure	Experimental	Procedure: DCE-MRI scans, Other: GadobutrolAll subjects will undergo DCE-MRI scanning conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 T system

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Male or females over 18 years of age at the time of signing the informed consent.
Body weight >=50 kilogram (kg) and Body Mass Index (BMI) within the range 18.0-40.0 kilogram/square meter (kg/m^2) (inclusive).
Able to understand and comply with protocol requirements, instructions and protocol stated restrictions and is willing to take part in the imaging sessions.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Inclusion Criteria for Heart Failure Group (group 2) - Established diagnosis of mild to moderate heart failure of any aetiology with symptoms defined as corresponding to the New York Heart Association (NYHA) class II or III.

Key exclusion criteria (19 listed)

History of known primary pulmonary disease requiring current medication or other therapy.
Orthopnoea of sufficient severity to preclude supine scanning as determined at screening.
Unstable angina within the past 3 months.
Uncontrolled hypertension (resting systolic Blood Pressure (BP) >160 millimeters of mercury (mmHg) or resting diastolic BP >100 mmHg).
Resting hypoxia while breathing room air (Saturation of Oxygen [SaO2] <88%). Exclusion Criteria for Healthy Volunteer Group and Heart Failure Groups

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
DCE-MRI scansSubjects will be placed supine in the scanner and will be prepared for intravenous contrast agent administration. The contrast agent is administered using a power injector before imaging.	Procedure or surgery	Acute decompensated heart failure, Healthy volunteers, Heart failure patients
GadobutrolGadobutrol at a dose less than or equal to 0.1 millimoles per kilogram (mmol/kg) will be given intravenously as a bolus using a power injector.	Other	Acute decompensated heart failure, Healthy volunteers, Heart failure patients

Primary outcome

Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers at Baseline
Time frame: Day 1
Interstitial volume (ve) was measured by DCE-MRI. ve for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal has been presented. Session 1 values were considered as Baseline values.
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers at Baseline
Time frame: Day 1
Exchange rate (Ktrans) was measured by DCE-MRI. Ktrans for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal has been presented. Session 1 values were considered as Baseline values.
Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Time frame: Day 11
Interstitial volume (ve) was measured by DCE-MRI. ve for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal before and following exercise has been presented.
Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise
Time frame: Day 11
Exchange rate (Ktrans) was measured by DCE-MRI. Ktrans for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal before and following exercise has been presented.
Change in Interstitial Volume (ve) in ADHF Participants
Time frame: Up to Week 8
Interstitial volume (ve) was measured by DCE-MRI. Three participants underwent 3 DCE-MRI scans. The data has been presented for individual participant in each session. The data presented below is only for total lung.
Change in Exchange Rate (Ktrans) in ADHF Participants
Time frame: Up to Week 8
Exchange rate (Ktrans) was measured by DCE-MRI. Three participants underwent 3 DCE-MRI scans. The data has been presented for individual participant in each session. The data presented below is only for total lung.

2 secondary outcomes

Assessment of Intra-subject Variability in Ve Between Session 1 and Session 2 of DCE-MRI
Time frame: Day 1 (Session 1) and Day 9 (Session 2)
Assessment of Intra-subject Variability in Ktrans Between Session 1 and Session 2 of DCE-MRI
Time frame: Day 1 (Session 1) and Day 9 (Session 2)

Results and safety

Results posted to the registry on 27 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Volunteers	21	21
Heart Failure Participants	12	12
Acute Decompensated Heart Failure Participants	3	3

Primary outcome: Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers at Baseline

Time frame: Day 1. Least squares mean (Standard Error). Unit: Liter

Measure	Healthy Volunteers n = 17	Heart Failure Participants n = 12
Total lung	0.4946 (0.0362)	0.3346 (0.0325)
Left lung	0.5078 (0.0349)	0.3253 (0.0317)
Right lung	0.4960 (0.0417)	0.3395 (0.0371)
Left lung apical	0.4952 (0.0339)	0.3188 (0.0306)
Left lung basal	0.5349 (0.0397)	0.3350 (0.0362)
Right lung apical	0.4865 (0.0392)	0.3506 (0.0352)
Right lung basal	0.5045 (0.0444)	0.3297 (0.0390)

Healthy Volunteers vs Heart Failure Participants: Mean Difference (Final Values): 0.1600 (95% CI 0.0600 to 0.2600), p = 0.0029, ANOVA
Healthy Volunteers vs Heart Failure Participants: Mean Difference (Final Values): 0.1825 (95% CI 0.0855 to 0.2795), p = 0.0007, ANOVA
Healthy Volunteers vs Heart Failure Participants: Mean Difference (Final Values): 0.1565 (95% CI 0.0419 to 0.2711), p = 0.0093, ANOVA

Population analysed: The Evaluable Population will include participants in safety population who are 40 years and older .The safety Population includes all enrolled participants who have initiated Session 1 DCE-MRI scan

Primary outcome: Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers at Baseline

Time frame: Day 1. Least squares mean (Standard Error). Unit: Liter/minute

Measure	Heart Failure Participants n = 12	Healthy Volunteers n = 17
Total lung	0.2216 (0.0298)	0.2353 (0.0273)
Left lung	0.2309 (0.0256)	0.2173 (0.0236)
Right lung	0.2216 (0.0338)	0.2474 (0.0309)
Left lung apical	0.2166 (0.0265)	0.2161 (0.0244)
Left lung basal	0.2621 (0.0270)	0.2225 (0.0249)
Right lung apical	0.2166 (0.0355)	0.2528 (0.0326)
Right lung basal	0.2313 (0.0329)	0.2431 (0.0301)

Heart Failure Participants vs Healthy Volunteers: Mean Difference (Final Values): -0.0137 (95% CI -0.0968 to 0.0695), p = 0.7381, ANOVA
Heart Failure Participants vs Healthy Volunteers: Mean Difference (Final Values): 0.0136 (95% CI -0.0580 to 0.0852), p = 0.6992, ANOVA
Heart Failure Participants vs Healthy Volunteers: Mean Difference (Final Values): -0.0258 (95% CI -0.1201 to 0.0684), p = 0.5778, ANOVA

Population analysed: The Evaluable Population

Primary outcome: Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise

Time frame: Day 11. Least squares mean (Standard Error). Unit: Liter

Measure	Heart Failure Participants n = 12	Healthy Volunteers n = 17
Pre-exercise; Total lung	0.4353 (0.0335)	0.3205 (0.0292)
Post-exercise; Total lung	0.4568 (0.0307)	0.3140 (0.0263)
Pre-exercise; Left lung	0.4487 (0.0311)	0.3121 (0.0267)
Post-exercise; Left lung	0.4832 (0.0266)	0.3055 (0.0228)
Pre-exercise; Right lung	0.4361 (0.0357)	0.3294 (0.0311)
Post-exercise; Right lung	0.4534 (0.0355)	0.3274 (0.0298)
Pre-exercise; Left lung apical	0.4272 (0.0335)	0.3126 (0.0289)
Post-exercise; Left lung apical	0.4449 (0.0257)	0.2986 (0.0216)

Heart Failure Participants vs Healthy Volunteers: Mean Difference (Final Values): 0.1148 (95% CI 0.0236 to 0.2061), p = 0.0156, ANOVA
Heart Failure Participants vs Healthy Volunteers: Mean Difference (Final Values): 0.1366 (95% CI 0.0523 to 0.2209), p = 0.0026, ANOVA
Heart Failure Participants vs Healthy Volunteers: Mean Difference (Final Values): 0.1067 (95% CI 0.0094 to 0.2040), p = 0.0328, ANOVA

Population analysed: The Evaluable Population

Primary outcome: Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise

Time frame: Day 11. Least squares mean (Standard Error). Unit: Liter/minute

Measure	Heart Failure Participants n = 12	Healthy Volunteers n = 17
Pre-exercise; Total lung	0.2044 (0.0281)	0.2567 (0.0247)
Post-exercise; Total lung	0.1841 (0.0221)	0.2108 (0.0190)
Pre-exercise; Left lung	0.2102 (0.0285)	0.2525 (0.0245)
Post-exercise; Left lung	0.1785 (0.0200)	0.1986 (0.0172)
Pre-exercise; Right lung	0.2034 (0.0299)	0.2550 (0.0263)
Post-exercise; Right lung	0.1926 (0.0269)	0.2114 (0.0226)
Pre-exercise; Left lung apical	0.1856 (0.0293)	0.2459 (0.0253)
Post-exercise; Left lung apical	0.1621 (0.0199)	0.1780 (0.0167)

Heart Failure Participants vs Healthy Volunteers: Mean Difference (Final Values): -0.0524 (95% CI -0.1292 to 0.0244), p = 0.1730, ANOVA
Heart Failure Participants vs Healthy Volunteers: Mean Difference (Final Values): -0.0423 (95% CI -0.1196 to 0.0349), p = 0.2704, ANOVA
Heart Failure Participants vs Healthy Volunteers: Mean Difference (Final Values): -0.0515 (95% CI -0.1334 to 0.0303), p = 0.2072, ANOVA

Population analysed: The Evaluable Population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) and AEs related to study procedure were planned to be collected from the start of study procedure and up to last visit (Up to Week 8). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Volunteers	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Heart Failure Patients	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Acute Decompensated Heart Failure	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DCE-MRI scans and Gadobutrol in people with Heart Failure, Congestive, run by GlaxoSmithKline at 1 site in United Kingdom.

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 16 inclusion and 19 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 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 27 Feb 2019). 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?

Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers at Baseline (time frame: Day 1). The study lists 6 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 NCT02135861.

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 27 Feb 2019.