Heart FailurePhase 2NCT01125514

A Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction Between Aliskiren and Furosemide in Patients With Heart Failure

A Phase 2 study testing Aliskiren 150 mg, Furosemide 60 mg and Aliskiren 300 mg in people with Heart Failure, run by Novartis Pharmaceuticals at 2 sites in 2 countries.

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

This study assessed the interaction between single and multiple doses of aliskiren (150 mg and 300 mg) and furosemide (60 mg) in patients with heart failure. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Heart Failure
What is being tested?: Aliskiren 150 mg, Furosemide 60 mg and Aliskiren 300 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 37 participants
Where: 2 sitesin 2 countries
Study dates: May 2010to Aug 2011
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Systolic or diastolic heart failure, diagnosed with either NYHA functional class II to III at least 3 months prior to screening and on stable medication for at least 12 weeks.
Patients must have met either of the criteria at screening:
Documented left ventricular ejection fraction (LVEF) greater than 20% but lower than 40% OR
Patients with a documented LVEF greater than 40% and with a history of NT-pro-BNP> 400pg/mL (or BNP > 100pg/mL) within 12 months of screening.

Who cannot join

Treatment with Angiotensin Receptor Blockers (ARBs), aldosterone receptor antagonists and diuretics (other than furosemide) within 3 weeks of first dose and during the study. Beta blockers were permitted provided the dose was stable for at least 3 weeks before the first dose and remains so throughout the study.
Hypertrophic cardiomyopathy (HCMP).
If a subject is currently treated with furosemide, the dose must be stable for at least 3 weeks before the first dose and the dose must not exceed 60 mg daily
Stable heart failure requiring treatment with both an ACE inhibitor and an ARB or Current acute decompensated heart failure.
Mean sitting systolic blood pressure ≥160 mmHg and/or mean sitting diastolic blood pressure ≥ 100mmHg and/or secondary forms of hypertension.
Persistent sitting systolic blood pressure <90 mmHg.
History of angioedema.
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Germany1 site

Novartis Investigative Site
Berlin

Other trials in Germany

Lithuania1 site

Novartis Investigative Site
Vilnius

Other trials in Lithuania

About this study

Official title: A Single-blind, Multiple Dose, Placebo-controlled, Double Dummy Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction Between Aliskiren and Furosemide in Patients With Heart Failure

This study assessed the interaction between single and multiple doses of aliskiren (150 mg and 300 mg) and furosemide (60 mg) in patients with heart failure.

Conditions: Heart Failure
Being tested: Aliskiren 150 mg, Furosemide 60 mg, Placebo for Aliskiren, Aliskiren 300 mg
Keywords: Heart failure,, aliskiren,, furosemide,, diuretic efficacy,, interaction
Medical subject headings: Heart Failure

What participants receive

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

Aliskiren 150 mgDrug
Aliskiren 150 mg tablet
Furosemide 60 mgDrug
Furosemide 60 mg commercially-available tablets
Placebo for AliskirenDrug
Matching placebo for aliskiren 150 mg and 300 mg
Aliskiren 300 mgDrug
Aliskiren 300 mg tablet

Study groups in NCT01125514
Study group	Role	What they receive
Furosemide 60 mg	Experimental	Treatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily. Receives: Drug: Furosemide 60 mg; Drug: Placebo for Aliskiren
Furosemide 60 mg + Aliskiren 150 mg	Experimental	Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily. Receives: Drug: Aliskiren 150 mg; Drug: Furosemide 60 mg; Drug: Placebo for Aliskiren
Furosemide 60 mg + Aliskiren 300 mg	Experimental	Treatment Period 3 (Day 18 to day 27): Patients received 60 mg furosemide, 300 mg aliskiren and 150 mg placebo of aliskiren once daily. Receives: Drug: Furosemide 60 mg; Drug: Placebo for Aliskiren; Drug: Aliskiren 300 mg

What is being measured

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

Diuretic Efficacy Index 1 for Sodium Excretion
Efficacy of furosemide for sodium excretion (efficacy index 1) was defined by dividing urinary sodium excretion by the urinary excretion of furosemide. Diuretic index 1 for sodium was calculated for the for the total 0 to 4 hour urine collection.
Measured: 0 to 4 hours
Diuretic Efficacy Index 1 for Sodium Excretion
Efficacy of furosemide for sodium excretion (efficacy index 1) was defined by dividing urinary sodium excretion by the urinary excretion of furosemide. Diuretic index 1 for sodium was calculated for the for the total 0 to 24 hour urine collection.
Measured: 0 to 24 hours
Diuretic Efficacy Index 2 for Water Excretion
Efficacy of furosemide for water excretion (efficacy index 2) was defined by dividing urine volume by the urinary excretion of furosemide.Diuretic index 2 for water was calculated for the 0 to 4 hour fraction urine collection.
Measured: 0 to 4 hours
Diuretic Efficacy Index 2 for Water Excretion
Efficacy of furosemide for water excretion (efficacy index 2) was defined by dividing urine volume by the urinary excretion of furosemide.Diuretic index 2 for water was calculated for the 0 to 4 hour fraction and for the total 0 to 24 hour urine collection.
Measured: 0 to 24 hours

Secondary outcomes (13)

Plasma Pharmacokinetics (PK) of Furosemide: Area Under the Plasma Concentration-time Curve (AUC)
Pharmacokinetic (PK) parameters were determined from the plasma concentration time profile of furosemide using a non-compartmental method:
AUCtau: Area under the plasma concentration-time curve from time zero to the end of the dosing interval
AUC (0-24): Area under the plasma concentration-time curve from time zero to 24 hours
AUClast: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. AUClast was calculated as the sum of linear trapezoids using non-compartmental analysis.
AUCinf: Area under the plasma concentration-time curve from time zero to infinity. AUCinf was calculated by adding AUClast and the value obtained from dividing the last measurable plasma concentration by λz, where λz was determined from automated linear regression of the last three time points with non-zero concentrations in the terminal phase of the log-transformed concentration-time profile
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose
Plasma Pharmacokinetics (PK) of Furosemide: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax, ss)
Cmax,ss was directly determined from the raw plasma concentration-time data.
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose
Plasma Pharmacokinetics (PK) of Furosemide: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Tmax was directly determined from the raw plasma concentration-time data.
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose
Plasma Pharmacokinetics (PK) of Furosemide: Average Steady State Plasma Concentration During Multiple Dosing (Cav,ss)
The average steady-state drug concentration in the plasma, blood, serum, or other body fluids during multiple dosing [amount x volume-1]. This was estimated as AUCτ/τ
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose
Plasma Pharmacokinetics (PK) of Furosemide: Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin, ss)
The minimum observed steady-state drug concentration in the plasma, blood, serum, or other body fluids at the end of the dosing interval during multiple dosing [amount x volume-1]
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24 hours post dose
Urine Pharmacokinetics (PK) of Furosemide: Amount of Drug Excreted Into the Urine From Time Zero to 24 Hours After Administration (Ae0-24)
The area under the plasma (or serum or blood) concentration-time curve from time zero to 24 h [mass × time × volume-1]
Measured: 0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose
Urine Pharmacokinetics (PK) of Furosemide: Renal Clearance (CLR)
The renal clearance of drug [volume x time-1]
Measured: 0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose
Creatinine Clearance
Creatinine clearance= (Urine creatinine/Serum creatinine) x (Urine volume/(24*60)).
Measured: 0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose
Urine Sodium and Potassium Excretion Per Treatment at 4 Hours Postdose
Urine was collected 4 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 4 hours.
Measured: 4 hours postdose
Urine Sodium and Potassium Excretion Per Treatment at 8 Hours Postdose
Urine was collected 8 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 8 hours.
Measured: 8 hours postdose
Urine Sodium and Potassium Excretion Per Treatment at 12 Hours Postdose
Urine was collected 12 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 12 hours.
Measured: 12 hours postdose
Urine Sodium and Potassium Excretion Per Treatment at 24 Hours Postdose
Urine was collected 24 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 24 hours.
Measured: 24 hours postdose
Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP)
Sitting blood pressure was measured three times at 1 to 2-minute intervals. The mean of the three sitting blood pressure measurements was used as the average of the sitting office blood pressure. The msSBP and msDBP data were analyzed using a mixed effect model with fixed effects from treatment and treatment*time; random effect from patients and predose as covariate.
Measured: 0.5 hour pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose.

Timeline

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

May 2010Aug 2011

First posted18 May 2010 (estimated)
Study startMay 2010
Primary completionAug 2011
Study completionAug 2011

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 FailureStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe 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: Non-randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01125514
Sponsor's protocol ID: CSPP100A2255
Status last verified: Aug 2012
First submitted: 17 May 2010
Last updated: 10 Sep 2012
Results posted: Yes, on ClinicalTrials.gov

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

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-blind, Multiple Dose, Placebo-controlled, Double Dummy Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction Between Aliskiren and Furosemide in Patients With Heart Failure
ClinicalTrials.gov ID: NCT01125514
Acronym / sponsor ID: CSPP100A2255
Conditions: Heart Failure
Keywords: Heart failure,, aliskiren,, furosemide,, diuretic efficacy,, interaction
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 18 May 2010 (estimated)
Results: Posted 10 Sep 2012

Clinical summary

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

This study assessed the interaction between single and multiple doses of aliskiren (150 mg and 300 mg) and furosemide (60 mg) in patients with heart failure.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Furosemide 60 mg	Experimental	Drug: Furosemide 60 mg, Drug: Placebo for AliskirenTreatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily.
Furosemide 60 mg + Aliskiren 150 mg	Experimental	Drug: Aliskiren 150 mg, Drug: Furosemide 60 mg, Drug: Placebo for AliskirenTreatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily.
Furosemide 60 mg + Aliskiren 300 mg	Experimental	Drug: Furosemide 60 mg, Drug: Placebo for Aliskiren, Drug: Aliskiren 300 mgTreatment Period 3 (Day 18 to day 27): Patients received 60 mg furosemide, 300 mg aliskiren and 150 mg placebo of aliskiren once daily.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Systolic or diastolic heart failure, diagnosed with either NYHA functional class II to III at least 3 months prior to screening and on stable medication for at least 12 weeks.
Patients must have met either of the criteria at screening:
Documented left ventricular ejection fraction (LVEF) greater than 20% but lower than 40% OR
Patients with a documented LVEF greater than 40% and with a history of NT-pro-BNP> 400pg/mL (or BNP > 100pg/mL) within 12 months of screening.

Key exclusion criteria (8 listed)

Treatment with Angiotensin Receptor Blockers (ARBs), aldosterone receptor antagonists and diuretics (other than furosemide) within 3 weeks of first dose and during the study. Beta blockers were permitted provided the dose was stable for at least 3 weeks before the first dose and remains so throughout the study.
Hypertrophic cardiomyopathy (HCMP).
If a subject is currently treated with furosemide, the dose must be stable for at least 3 weeks before the first dose and the dose must not exceed 60 mg daily
Stable heart failure requiring treatment with both an ACE inhibitor and an ARB or Current acute decompensated heart failure.
Mean sitting systolic blood pressure ≥160 mmHg and/or mean sitting diastolic blood pressure ≥ 100mmHg and/or secondary forms of hypertension.

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
Aliskiren 150 mgAliskiren 150 mg tablet	Drug	Furosemide 60 mg + Aliskiren 150 mg
Furosemide 60 mgFurosemide 60 mg commercially-available tablets	Drug	Furosemide 60 mg, Furosemide 60 mg + Aliskiren 150 mg, Furosemide 60 mg + Aliskiren 300 mg
Placebo for AliskirenMatching placebo for aliskiren 150 mg and 300 mg	Drug	Furosemide 60 mg, Furosemide 60 mg + Aliskiren 150 mg, Furosemide 60 mg + Aliskiren 300 mg
Aliskiren 300 mgAliskiren 300 mg tablet	Drug	Furosemide 60 mg + Aliskiren 300 mg

Primary outcome

Diuretic Efficacy Index 1 for Sodium Excretion
Time frame: 0 to 4 hours
Efficacy of furosemide for sodium excretion (efficacy index 1) was defined by dividing urinary sodium excretion by the urinary excretion of furosemide. Diuretic index 1 for sodium was calculated for the for the total 0 to 4 hour urine collection.
Diuretic Efficacy Index 1 for Sodium Excretion
Time frame: 0 to 24 hours
Efficacy of furosemide for sodium excretion (efficacy index 1) was defined by dividing urinary sodium excretion by the urinary excretion of furosemide. Diuretic index 1 for sodium was calculated for the for the total 0 to 24 hour urine collection.
Diuretic Efficacy Index 2 for Water Excretion
Time frame: 0 to 4 hours
Efficacy of furosemide for water excretion (efficacy index 2) was defined by dividing urine volume by the urinary excretion of furosemide.Diuretic index 2 for water was calculated for the 0 to 4 hour fraction urine collection.
Diuretic Efficacy Index 2 for Water Excretion
Time frame: 0 to 24 hours
Efficacy of furosemide for water excretion (efficacy index 2) was defined by dividing urine volume by the urinary excretion of furosemide.Diuretic index 2 for water was calculated for the 0 to 4 hour fraction and for the total 0 to 24 hour urine collection.

13 secondary outcomes

Plasma Pharmacokinetics (PK) of Furosemide: Area Under the Plasma Concentration-time Curve (AUC)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose
Plasma Pharmacokinetics (PK) of Furosemide: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax, ss)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose
Plasma Pharmacokinetics (PK) of Furosemide: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose
Plasma Pharmacokinetics (PK) of Furosemide: Average Steady State Plasma Concentration During Multiple Dosing (Cav,ss)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose
Plasma Pharmacokinetics (PK) of Furosemide: Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin, ss)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24 hours post dose
Urine Pharmacokinetics (PK) of Furosemide: Amount of Drug Excreted Into the Urine From Time Zero to 24 Hours After Administration (Ae0-24)
Time frame: 0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose
Urine Pharmacokinetics (PK) of Furosemide: Renal Clearance (CLR)
Time frame: 0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose
Creatinine Clearance
Time frame: 0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose
Urine Sodium and Potassium Excretion Per Treatment at 4 Hours Postdose
Time frame: 4 hours postdose
Urine Sodium and Potassium Excretion Per Treatment at 8 Hours Postdose
Time frame: 8 hours postdose
Urine Sodium and Potassium Excretion Per Treatment at 12 Hours Postdose
Time frame: 12 hours postdose
Urine Sodium and Potassium Excretion Per Treatment at 24 Hours Postdose
Time frame: 24 hours postdose
Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: 0.5 hour pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose.

Results and safety

Results posted to the registry on 10 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Furosemide (Fu) /Fu+Aliskiren(Alis)150mg/fu+Alis 300mg	37	35

Primary outcome: Diuretic Efficacy Index 1 for Sodium Excretion

Time frame: 0 to 4 hours. Mean (Standard Deviation). Unit: mmol/mg

Measure	Furosemide 60 mg + Aliskiren Placebo n = 33	Furosemide 60 mg+ Single Dose Aliskiren 150mg n = 32	Furosemide 60 mg + Multiple Dose Aliskiren 150mg n = 31	Furosemide 60 mg + Multiple Dose Aliskiren 300mg n = 28
Value	10.185 (4.4568)	12.122 (6.2867)	13.453 (8.3524)	12.858 (6.1040)

Population analysed: All patients who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data with no major protocol deviation in at least one period were included in the PD analysis set.

Primary outcome: Diuretic Efficacy Index 1 for Sodium Excretion

Time frame: 0 to 24 hours. Mean (Standard Deviation). Unit: mmol/mg

Measure	Furosemide 60 mg + Aliskiren Placebo n = 31	Furosemide 60 mg+ Single Dose Aliskiren 150mg n = 31	Furosemide 60 mg + Multiple Dose Aliskiren 150mg n = 30	Furosemide 60 mg + Multiple Dose Aliskiren 300mg n = 28
Value	10.775 (5.2486)	13.264 (6.3535)	13.364 (6.1511)	14.747 (6.3531)

Primary outcome: Diuretic Efficacy Index 2 for Water Excretion

Time frame: 0 to 4 hours. Mean (Standard Deviation). Unit: mL/mg

Measure	Furosemide 60 mg + Aliskiren Placebo n = 33	Furosemide 60 mg + Single Dose Aliskiren 150mg n = 32	Furosemide 60 mg + Multiple Dose Aliskiren 150mg n = 31	Furosemide 60 mg + Multiple Dose Aliskiren 300mg n = 28
Value	90.402 (34.7866)	109.773 (50.2433)	119.239 (63.3655)	122.157 (58.8815)

Population analysed: All patients who received at least one dose of study drug and had evaluable PD data with no major protocol deviation in at least one period were included in the PD analysis set.

Primary outcome: Diuretic Efficacy Index 2 for Water Excretion

Time frame: 0 to 24 hours. Mean (Standard Deviation). Unit: mL/mg

Measure	Furosemide 60 mg + Aliskiren Placebo n = 31	Furosemide 60 mg + Single Dose Aliskiren 150mg n = 32	Furosemide 60 mg + Multiple Dose Aliskiren 150mg n = 30	Furosemide 60 mg + Multiple Dose Aliskiren 300mg n = 28
Value	119.439 (46.2607)	151.859 (53.6734)	154.116 (40.5598)	175.112 (59.4236)

Population analysed: All patients who received at least one dose of study drug and had evaluable PD data with no major protocol deviation in at least one period were included in the PD analysis set.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
60 mg Furosemide + 150 mg Placebo + 300 mg Placebo	2 of 37 (5.4%)	0 of 37 (0%)	Not reported
60 mg Furosemide + 150 mg Aliskiren + 300 mg Placebo	0 of 33 (0%)	0 of 33 (0%)	Not reported
60 mg Furosemide + 300 mg Aliskiren + 150 mg Placebo	0 of 31 (0%)	0 of 31 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Heart Failure

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

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.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aliskiren 150 mg, Furosemide 60 mg and Aliskiren 300 mg in people with Heart Failure, run by Novartis Pharmaceuticals at 2 sites in 2 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 4 inclusion and 8 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 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, Lithuania. 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 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 10 Sep 2012). 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?

Diuretic Efficacy Index 1 for Sodium Excretion (time frame: 0 to 4 hours). The study lists 4 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 NCT01125514.

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 10 Sep 2012.