Clinical trial NCT01353508: Sodium Excretion of LCZ696 in Patients With Hypertension; Heart Failure and Healthy Volunteers
Official title: A Randomized, Double-blind, Controlled, Crossover Study to Evaluate the Sodium Excretion of LCZ696 in Patients With Stable Heart Failure, in Patients With Hypertension, and in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: Sodium excretion,
LCZ696
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-05-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Assess mechanism of action of LCZ696 related to sodium excretion.


Eligibility criteria: Inclusion Criteria:

* Patients with heart failure: documented NYHA class II-III heart failure
* Patients with hypertension: stable hypertensive medication for the preceding 2 months

Exclusion Criteria:

* Women of childbearing potential
* History of recent myocardial infarction
* History of dialysis or renal transplant
* Patients with type 1 diabetes mellitus

Primary outcomes:
measure: 24-hour Urinary Sodium Excretion
timeFrame: day 1
measure: Cumulative 7-day Urinary Sodium Excretion
timeFrame: 7 day-cummulative (days 1 through 7)
Secondary outcomes:
measure: 24-hour Diuresis
timeFrame: day 1
measure: 7-day Cumulative Diuresis
timeFrame: 7-day cumulative (days 1 through 7)
measure: Urinary Cyclic Guanosine Monophosphate (cGMP) Excretion Over 24 Hours
timeFrame: day 1, day 6, day 7
measure: Percent Change From Baseline in Plasma Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) Biomarker
timeFrame: 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 2, 4, 6 and 12 hours post dose on day 7
measure: Percent Change From Baseline in Brain Natriuretic Peptide (BNP) Biomarker
timeFrame: 0.5, 1, 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7
measure: Percent Change From Baseline in Mid-regional Pro-adrenomedullin (MR-proADM) Biomarker
timeFrame: 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7
measure: Percent Change From Baseline in C-type Natriuretic Peptide (proCNP) Biomarker
timeFrame: 2, 4, 6, 8 and 12 hours post dose on day 1; day 2; 0, 4, 6, 8 and 12 hours post dose on day 7
measure: Percent Change From Baseline in C-terminal-proendothelin-1 (CT-proET-1) Biomarker
timeFrame: 12 hours post dose on day 1; 24 hours post dose on day 2; 0 and 12 hours post dose on day 7
measure: Percent Change From Baseline in N-terminal-proBNP (NT-proBNP) Biomarker
timeFrame: 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7
measure: Percent Change From Baseline in Aldosterone Biomarker
timeFrame: 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 6 and 12 hours post dose on day 7
measure: Percent Change From Baseline in Urinary Electrolyte Excretion (Sodium, Potassium, Chloride and Calcium)
timeFrame: 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7
measure: Percent Change From Baseline in Blood Plasma Creatinine
timeFrame: 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7
measure: Glomerular Filtration Rate (GFR) Over Time
timeFrame: 0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7
measure: Renal Blood Flow (RBF) Over Time
timeFrame: 0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7
measure: Supine Systolic Blood Pressure
timeFrame: 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7
measure: Supine Diastolic Blood Pressure
timeFrame: 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7
measure: Supine Pulse Rate
timeFrame: 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: